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NCT03691090 · CITED IN SOURCE DOCUMENTS

Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2022-12-07

This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
Inclusion Criteria: 1. Histologically or cytologically confirmed unresectable local advanced/recurrent or metastasis esophageal squamous cell carcinoma; 2. No previous systemic anti-tumor treatment; 3. Subjects must have at least one measurable tumor lesion per RECIST 1.1; 4. Tissue samples should be provided for biomarkers (such as PD-L1) analysis; 5. ECOG: 0-1; 6. Adequate organ and bone marrow function; Exclusion Criteria: 1. Allergic to monoclonal antibodies, any SHR-1210 components, paclitaxel, cisplatin and other platinum drugs; 2. Prior therapy as follow: 1. Anti-PD-1 or anti-PD-L1; 2. Any experimental drugs within 4 weeks of the first dose of study medication; 3. Received major operations or serious injuries within 4 weeks of the first dose of study medication; 4. Received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication; 3. Not recovered to ≤CTCAE 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment; 4. Subjects with any active autoimmune disease or history of autoimmune disease; 5. Pregnancy or breast feeding;
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，SHR-1210 200mg，Day 2，every 3 weeks, maximum 6 cycles, then SHR-1210 maintenance
    intervention Names
    1. Drug: SHR-1210
    2. Drug: paclitaxel
    3. Drug: cisplatin
    label
    SHR-1210 + paclitaxel + cisplatin
    type
    EXPERIMENTAL
  2. description
    Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
    intervention Names
    1. Drug: Placebo
    2. Drug: paclitaxel
    3. Drug: cisplatin
    label
    placebo+paclitaxel + cisplatin
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. SHR-1210 + paclitaxel + cisplatin
    description
    SHR-1210 200mg
    name
    SHR-1210
    other Names
    1. camrelizumab
    type
    DRUG
  2. arm Group Labels
    1. placebo+paclitaxel + cisplatin
    description
    Placebo
    name
    Placebo
    type
    DRUG
  3. arm Group Labels
    1. SHR-1210 + paclitaxel + cisplatin
    2. placebo+paclitaxel + cisplatin
    description
    paclitaxel 175mg/m2
    name
    paclitaxel
    type
    DRUG
  4. arm Group Labels
    1. SHR-1210 + paclitaxel + cisplatin
    2. placebo+paclitaxel + cisplatin
    description
    cisplatin 75mg/m2
    name
    cisplatin
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
QUADRUPLE
who Masked
  1. PARTICIPANT
  2. CARE_PROVIDER
  3. INVESTIGATOR
  4. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
596
type
ACTUAL
Registered outcome plans (not posted results)
other Outcomes
  1. description
    To evaluate the incidence of ADAs against SHR-1210
    measure
    Antidrug Antibodies (ADAs)
    time Frame
    approximately 22 months
primary Outcomes
  1. description
    based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
    measure
    PFS assessed by IRC
    time Frame
    approximately 22 months
  2. description
    OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
    measure
    OS
    time Frame
    approximately 22 months
secondary Outcomes
  1. description
    based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
    measure
    PFS assessed by investigators
    time Frame
    approximately 22 months
  2. description
    OS is defined as the time from registration to death due to any cause, or censored at date last known alive. Measured by the method of Kaplan and Meier.
    measure
    6 and 9 month OS rate
    time Frame
    approximately 6 and 9 months
  3. description
    based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
    measure
    ORR
    time Frame
    approximately 22 months
  4. description
    based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
    measure
    DCR
    time Frame
    approximately 22 months
  5. description
    based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
    measure
    DoR
    time Frame
    approximately 22 months
  6. description
    adverse events
    measure
    AE
    time Frame
    approximately 22 months
Full study description
brief Summary
This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial, comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
detailed Description
In this study, eligible subjects will be randomized into study arm or control arm. Treatment cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators. Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and overall survival (OS) will be the primary outcomes.
Source references
references
  1. citation
    Zhang Y, Li C, Du K, Pengkhun N, Huang Z, Gong M, Li Y, Liu X, Li L, Wang D, Wang C, Chen F, Li J. Comparative analysis of immune checkpoint inhibitors in first-line treatment of esophageal squamous cell carcinoma: a network meta-analysis. Immunotherapy. 2023 Jul;15(10):737-750. doi: 10.2217/imt-2022-0236. Epub 2023 May 4.
    pmid
    37139963
    type
    DERIVED
  2. citation
    Luo H, Lu J, Bai Y, Mao T, Wang J, Fan Q, Zhang Y, Zhao K, Chen Z, Gao S, Li J, Fu Z, Gu K, Liu Z, Wu L, Zhang X, Feng J, Niu Z, Ba Y, Zhang H, Liu Y, Zhang L, Min X, Huang J, Cheng Y, Wang D, Shen Y, Yang Q, Zou J, Xu RH; ESCORT-1st Investigators. Effect of Camrelizumab vs Placebo Added to Chemotherapy on Survival and Progression-Free Survival in Patients With Advanced or Metastatic Esophageal Squamous Cell Carcinoma: The ESCORT-1st Randomized Clinical Trial. JAMA. 2021 Sep 14;326(10):916-925. doi: 10.1001/jama.2021.12836.
    pmid
    34519801
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
      1. context exact
        , and 108 patients (36%) who received chemotherapy alone. No new safety signals were observed.</li></ul></div></li><li>The results of <a href="/clinicaltrials/NCT03691090">ESCORT-1st</a> (NCT03691090), a randomized, double-blind, multicenter, placebo-controlled trial conducted in China, corroborated the positive impact of checkp
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      2. context exact
        received chemotherapy alone. No new safety signals were observed.</li></ul></div></li><li>The results of <a href="/clinicaltrials/NCT03691090">ESCORT-1st</a> (NCT03691090), a randomized, double-blind, multicenter, placebo-controlled trial conducted in China, corroborated the positive impact of checkpoint inhibitors combined with
        end
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      source retrieved at
      2026-09-09T23:21:40.423603+00:00
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      source string sha256
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      source title
      Esophageal Cancer Treatment (PDQ®)–Health Professional Version
      source update dates
      1. context
        Updated: March 21, 2025
        datetime
        2025-03-21T12:00:00Z
        display
        March 21, 2025

    Preserved source evidence · Not medical advice