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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-03

Study Completion Date

2022-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Advanced Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR-1210 + paclitaxel + cisplatin

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

Group Type EXPERIMENTAL

SHR-1210

Intervention Type DRUG

SHR-1210 200mg

paclitaxel

Intervention Type DRUG

paclitaxel 175mg/m2

cisplatin

Intervention Type DRUG

cisplatin 75mg/m2

placebo+paclitaxel + cisplatin

Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

paclitaxel

Intervention Type DRUG

paclitaxel 175mg/m2

cisplatin

Intervention Type DRUG

cisplatin 75mg/m2

Interventions

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SHR-1210

SHR-1210 200mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

paclitaxel

paclitaxel 175mg/m2

Intervention Type DRUG

cisplatin

cisplatin 75mg/m2

Intervention Type DRUG

Other Intervention Names

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camrelizumab

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No