NCT02435433 · STUDY IN CONTEXT

A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.

All randomized participants. Participants were censored in Ramucirumab arm = 50 and Placebo arm = 21. All randomized participants (including the censored participants) were included in the analyses.

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secondary · POSTED

Progression-free survival is defined as time from the date of randomization to the date of first observation of objective progression or death from any cause.

All randomized participants. Participants were censored in the Ramucirumab arm = 25 and in the Placebo arm = 9. All randomized participants (including the censored participants) were included in the analyses.

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secondary · POSTED

Time to radiographic progression is defined as the time from the date of randomization to the date of first observation of objective progression.

All randomized participants.

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secondary · POSTED

Objective response rate is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is the disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.

All randomized participants who received at least one dose of study drug.

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secondary · POSTED

PK Cmin of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.

All randomized participants who received at least one dose of study drug.

→

secondary · POSTED

PK Cmax of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.

All randomized participants who received at least one dose of study drug.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-liver-neoplasm
nct id: NCT02435433
qol key: qol-0007
source section id: NCT02435433-om-0007
source outcome index: 7
instrument: FACT
instrument basis: matched 'fact' in the study's own wording
scale title: Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
measure definition: The FACT Hepatobiliary Symptom Index (FHSI-8) is a instrument with specific focus regarding the most frequent and concerning symptoms experienced by participants with hepatobiliary malignancies, including lack of energy, nausea, pain, weight loss, pain in back, fatigue, jaundice, stomach pain or discomfort. The (FHSI-8) questionnaire was used to assess the time to deterioration of FSHI-8 total score issued from the date of randomization to the first date observing deterioration, with the deterioration threshold defined as a decrease ≥ 3-points from baseline. In case of no deterioration, the participants were censored at the time of the last FSHI-8 item recording. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. Kaplan-Meier method Hazard ratio was used to estimate (Ramucirumab versus Placebo) and 95% Confidence Interval (CI) (Wald) were estimated from un-stratified/stratified Cox model.
time frame: From Randomization to the First Date of Deterioration Observation (≥ 3-point decrease) (Up to 28 Months)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: All randomized participants who had evaluable FHSI-8 data.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

EQ-5D · Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id: clinical-indications-draft-1
disease state id: ds-liver-neoplasm
nct id: NCT02435433
qol key: qol-0008
source section id: NCT02435433-om-0008
source outcome index: 8
instrument: EQ-5D
instrument basis: matched 'eq-5d' in the study's own wording
scale title: Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
measure definition: The EQ-5D-5L is a nonspecific and standardized instrument for use as a measure of self-reported health status (EuroQol Group 1990; Herdman et al. 2011). Participants completed the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D-5L health state scale ranges from 0 to 100 and is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
time frame: From Randomization through End of Study (Up to 28 Months)
analysis role: secondary
reporting status: POSTED
higher is better: Source null
direction quote: Source null
population note: All randomized participants and had evaluable EQ-5D-5L data.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z

Open the exact result →

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-liver-neoplasm
nct id: NCT02435433
trial label: A Study of Ramucirumab (LY3009806) Versus Placebo in Participants With Hepatocellular Carcinoma and Elevated Baseline Alpha-Fetoprotein
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: regulator-cited
discovery note: Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count: 6
harms Count: 5
qol Count: 2

outcomes

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0000
source section id
NCT02435433-om-0000
source outcome index
0
endpoint
Overall Survival (OS)
endpoint definition
OS time was measured from date of randomization to date of death from any cause. Participants who were not known to have died on or before the date of data cut-off, OS data was censored on the last date (on or before the cut-off date) the participant was known to be alive.
time origin
From Date of Randomization to Death from Any Cause (Up to 28 Months)
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants. Participants were censored in Ramucirumab arm = 50 and Placebo arm = 21. All randomized participants (including the censored participants) were included in the analyses.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0001
source section id
NCT02435433-om-0001
source outcome index
1
endpoint
Progression Free Survival (PFS)
endpoint definition
Progression-free survival is defined as time from the date of randomization to the date of first observation of objective progression or death from any cause.
time origin
From Randomization to Objective Progression or Death from Any Cause (Up to 28 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants. Participants were censored in the Ramucirumab arm = 25 and in the Placebo arm = 9. All randomized participants (including the censored participants) were included in the analyses.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0002
source section id
NCT02435433-om-0002
source outcome index
2
endpoint
Time to Radiographic Progression
endpoint definition
Time to radiographic progression is defined as the time from the date of randomization to the date of first observation of objective progression.
time origin
From Randomization to Objective Progression (Up to 28 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0003
source section id
NCT02435433-om-0003
source outcome index
3
endpoint
Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR): Objective Response Rate (ORR)
endpoint definition
Objective response rate is defined as the percentage of participants who achieve a best overall response of complete response (CR) + partial response (PR). ORR = CR + PR. CR is the disappearance of all non-target lesions and normalisation of tumour marker level. All lymph nodes must be non-pathological in size (\<10 mm short axis). PR is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. CR: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Tumor marker results must have normalized. Best overall response is classified based on the overall responses assessed by study investigators according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1.
time origin
From Randomization to Objective Progression (Up to 28 Months)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants who received at least one dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0004
source section id
NCT02435433-om-0004
source outcome index
4
endpoint
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) Before 2nd, 4th, 7th, and 10th Infusion
endpoint definition
PK Cmin of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.
time origin
Predose, Weeks 2, 6, 12 and 18, Day 1; Up to 3 Days Before Infusion (14-Day Cycles)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants who received at least one dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0005
source section id
NCT02435433-om-0005
source outcome index
5
endpoint
PK: Serum Concentration Maximum (Cmax) After 1st, 2nd, 4th, 7th and 10th Ram Infusion
endpoint definition
PK Cmax of Ramucirumab Blood samples were collected at specified time points, and in the event of an infusion-related reaction, for assessment of ramucirumab serum concentrations.
time origin
Weeks 0, 2, 6, 12 and 18, Day 1; 1 hour to 1.5 hours Post End of Infusion (14 day-Cycles)
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All randomized participants who received at least one dose of study drug.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0000
arm key
OG000
arm label
Ramucirumab + Best Supportive Care (BSC)
regimen
8 milligrams per kilogram (mg/kg) ramucirumab administered as an intravenous (IV) injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
analyzed count
197
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0000
arm key
OG001
arm label
Placebo + BSC
regimen
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0001
arm key
OG000
arm label
Ramucirumab + BSC
regimen
8 mg/kg ramucirumab administered as an intravenous IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
analyzed count
197
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0001
arm key
OG001
arm label
Placebo + BSC
regimen
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0002
arm key
OG000
arm label
Ramucirumab + BSC
regimen
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
analyzed count
197
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0002
arm key
OG001
arm label
Placebo + BSC
regimen
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0003
arm key
OG000
arm label
Ramucirumab + BSC
regimen
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
analyzed count
197
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0003
arm key
OG001
arm label
Placebo + BSC
regimen
Placebo administered IV on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met. Participants still on treatment at the time of study completion may have the option to crossover to the ramucirumab arm.
analyzed count
95
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0003#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0004
arm key
OG000
arm label
Ramucirumab + BSC
regimen
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
analyzed count
195
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
outcome key
om-0005
arm key
OG000
arm label
Ramucirumab + BSC
regimen
8 mg/kg ramucirumab administered as an IV injection on day 1 of each 14 day cycle. Participants may continue treatment until discontinuation criteria are met.
analyzed count
195
analyzed unit
Participants
is comparator
Source null
source pointer
NCT02435433-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
harm key
EG000
source section id
NCT02435433-ae
event group key
EG000
event group label
Ramucirumab + BSC
serious affected
72
serious at risk
197
other affected
189
other at risk
197
frequency threshold
5
collection period
Baseline up to 3.2 years
event definition
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
harm key
EG001
source section id
NCT02435433-ae
event group key
EG001
event group label
Placebo+BSC
serious affected
27
serious at risk
95
other affected
77
other at risk
95
frequency threshold
5
collection period
Baseline up to 3.2 years
event definition
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
harm key
EG002
source section id
NCT02435433-ae
event group key
EG002
event group label
Open Label Ramucirumab + BSC
serious affected
18
serious at risk
47
other affected
40
other at risk
47
frequency threshold
5
collection period
Baseline up to 3.2 years
event definition
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
harm key
EG003
source section id
NCT02435433-ae
event group key
EG003
event group label
Ramucirumab MEE Cohort
serious affected
10
serious at risk
39
other affected
39
other at risk
39
frequency threshold
5
collection period
Baseline up to 3.2 years
event definition
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
harm key
EG004
source section id
NCT02435433-ae
event group key
EG004
event group label
Placebo MEE Cohort
serious affected
3
serious at risk
21
other affected
17
other at risk
21
frequency threshold
5
collection period
Baseline up to 3.2 years
event definition
All participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
qol key
qol-0007
source section id
NCT02435433-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'fact' in the study's own wording
scale title
Time to Deterioration of Functional Assessment of Cancer Therapy (FACT) Hepatobiliary Symptom Index-8 (FHSI-8)
measure definition
The FACT Hepatobiliary Symptom Index (FHSI-8) is a instrument with specific focus regarding the most frequent and concerning symptoms experienced by participants with hepatobiliary malignancies, including lack of energy, nausea, pain, weight loss, pain in back, fatigue, jaundice, stomach pain or discomfort. The (FHSI-8) questionnaire was used to assess the time to deterioration of FSHI-8 total score issued from the date of randomization to the first date observing deterioration, with the deterioration threshold defined as a decrease ≥ 3-points from baseline. In case of no deterioration, the participants were censored at the time of the last FSHI-8 item recording. FHSI-8 total score ranges from 0 to 32 where "0" is a severely symptomatic participant and the highest score indicates an asymptomatic participant. Kaplan-Meier method Hazard ratio was used to estimate (Ramucirumab versus Placebo) and 95% Confidence Interval (CI) (Wald) were estimated from un-stratified/stratified Cox model.
time frame
From Randomization to the First Date of Deterioration Observation (≥ 3-point decrease) (Up to 28 Months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized participants who had evaluable FHSI-8 data.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-liver-neoplasm
nct id
NCT02435433
qol key
qol-0008
source section id
NCT02435433-om-0008
source outcome index
8
instrument
EQ-5D
instrument basis
matched 'eq-5d' in the study's own wording
scale title
Change From Baseline in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Questionnaire
measure definition
The EQ-5D-5L is a nonspecific and standardized instrument for use as a measure of self-reported health status (EuroQol Group 1990; Herdman et al. 2011). Participants completed the 5-level (no problems, slight problems, moderate problems, severe problems, and extreme problems), 5-dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) questionnaire concerning their current health state. A unique EQ-5D-5L health state scale ranges from 0 to 100 and is defined by combining 1 level from each of the 5 dimensions. Participants indicated their current health status by marking on a continuum ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).
time frame
From Randomization through End of Study (Up to 28 Months)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
All randomized participants and had evaluable EQ-5D-5L data.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

setting source links

Preserved source evidence · Not medical advice