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← Penpulimab kcqx: metastatic Nasopharyngeal carcinoma after prior therapy

NCT03581786 · STUDY IN CONTEXT

The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. 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

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.

Source null

→

secondary · POSTED

Overall survival was defined as the time from randomization to death from any cause.

NE below means "not estimable".

→

secondary · POSTED

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.

Source null

→

secondary · POSTED

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.

Source null

→

secondary · POSTED

To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1.

Source null

→

secondary · POSTED

To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1

Source null

→

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

EORTC QLQ · IRC-assessed ORR According to RECIST v1.1

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-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT03581786
qol key
qol-0008
source section id
NCT03581786-om-0008
source outcome index
8
instrument
EORTC QLQ
instrument basis
matched 'eortc' in the study's own wording
scale title
IRC-assessed ORR According to RECIST v1.1
measure definition
health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35
time frame
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
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-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
nct id
NCT03581786
trial label
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
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
2
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0000
    source section id
    NCT03581786-om-0000
    source outcome index
    0
    endpoint
    IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1
    endpoint definition
    To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy as measured by IRC-assessed progression free survival (PFS) according to RECIST v1.1 in all patients. The definition of Progressive Disease: At least a 20% increasein the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. or the appearance of one or more new lesions is also considered progression.
    time origin
    up to 2 years
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0001
    source section id
    NCT03581786-om-0001
    source outcome index
    1
    endpoint
    OS
    endpoint definition
    Overall survival was defined as the time from randomization to death from any cause.
    time origin
    The time frame of OS collected is upto about 48months.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    NE below means "not estimable".
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0002
    source section id
    NCT03581786-om-0002
    source outcome index
    2
    endpoint
    Investigator-assessed ORR According to RECIST v1.1
    endpoint definition
    To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed overall response rate (ORR) according to RECIST v1.1.
    time origin
    From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0003
    source section id
    NCT03581786-om-0003
    source outcome index
    3
    endpoint
    Investigator-assessed DoR According to RECIST v1.1
    endpoint definition
    To evaluate the efficacy of TORIPALIMAB INJECTION(JS001 )plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed duration of response (DoR) according to RECIST v1.1.
    time origin
    From date of response until progressive disease. Up to 2 approximately years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0004
    source section id
    NCT03581786-om-0004
    source outcome index
    4
    endpoint
    Investigator-assessed DCR According to RECIST v1.1
    endpoint definition
    To evaluate the efficacy of TORIPALIMAB INJECTION(JS001) plus chemotherapy compared with placebo plus chemotherapy, as measured by investigator-assessed disease control rate (DCR) according to RECIST v1.1.
    time origin
    From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0005
    source section id
    NCT03581786-om-0005
    source outcome index
    5
    endpoint
    Investigator-assessed PFS According to RECIST v1.1
    endpoint definition
    To evaluate the efficacy of JS001 plus chemotherapy compared with placebo plus chemotherapy, as measured by Investigators-assessed PFS according to RECIST v1.1
    time origin
    From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo Combine With Chemotherapy
    regimen
    Placebos: placebo combine with chemotherapy
    analyzed count
    143
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0000
    arm key
    OG001
    arm label
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
    regimen
    TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy: TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
    analyzed count
    146
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
    analyzed count
    143
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0001
    arm key
    OG001
    arm label
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
    analyzed count
    146
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Placebo Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
    analyzed count
    143
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0002
    arm key
    OG001
    arm label
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
    analyzed count
    146
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Placebo Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
    analyzed count
    108
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0003
    arm key
    OG001
    arm label
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
    analyzed count
    120
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Placebo Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
    analyzed count
    143
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0004
    arm key
    OG001
    arm label
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
    analyzed count
    146
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Placebo Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，placebo will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and placebo for up to 2 years
    analyzed count
    143
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0005#groups/OG000
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    outcome key
    om-0005
    arm key
    OG001
    arm label
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
    regimen
    Gemcitabine 1000 mg/m² IV are given on Days 1 \& 8, and cisplatin 80 mg/m² IV are given on Day 1 of each cycle，JS001 will be administered at the dose of 240 mg Q3W before that. Chemotherapy is given Q3W for up to 6 cycles and JS001 for up to2years
    analyzed count
    146
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03581786-om-0005#groups/OG001
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    harm key
    EG000
    source section id
    NCT03581786-ae
    event group key
    EG000
    event group label
    Placebo Combine With Chemotherapy
    serious affected
    62
    serious at risk
    143
    other affected
    143
    other at risk
    143
    frequency threshold
    5
    collection period
    Up to approximately 48 months
    event definition
    All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    harm key
    EG001
    source section id
    NCT03581786-ae
    event group key
    EG001
    event group label
    TORIPALIMAB INJECTION(JS001 )Combine With Chemotherapy
    serious affected
    64
    serious at risk
    146
    other affected
    146
    other at risk
    146
    frequency threshold
    5
    collection period
    Up to approximately 48 months
    event definition
    All-Cause Mortality (ACM): all randomized participants, Up to approximately 48 months. AEs: All AEs were treatment-emergent AEs (TEAEs), defined as any AE which either began or worsened in severity on or after the date/time of first dose of study treatment and on or before 60 days after the date/time of last dose of study treatment.
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-nasopharyngeal-carcinoma-penpulimab-kcqx-b2e470d4
    nct id
    NCT03581786
    qol key
    qol-0008
    source section id
    NCT03581786-om-0008
    source outcome index
    8
    instrument
    EORTC QLQ
    instrument basis
    matched 'eortc' in the study's own wording
    scale title
    IRC-assessed ORR According to RECIST v1.1
    measure definition
    health related quality of life (HRQoL) in patients treated with JS001 plus chemotherapy compared with placebo plus chemotherapy using the EORTC QLQ-H\&N35
    time frame
    From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 2 approximately years
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    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