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

Phase 3

Completed

• Conditions: Advanced Esophageal Cancer
• Interventions: Drug: Placebo; Drug: SHR-1210; Drug: paclitaxel; Drug: cisplatin

• Registration Number: NCT03691090
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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.

Study Timeline

• Study First Submitted: 2018-09-21
• Study First Submitted QC: 2018-09-26
• Study First Posted: 2018-10-01
• Study Start: 2018-12-03
• Primary Completion: 2020-10-30
• Study Completion: 2022-04-30
• Status Verified: 2022-06
• Last Update Submitted: 2022-12-05
• Last Update Posted: 2022-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 596

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;

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo+paclitaxel + cisplatin	Placebo	Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
SHR-1210 + paclitaxel + cisplatin	SHR-1210	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
SHR-1210 + paclitaxel + cisplatin	paclitaxel	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
SHR-1210 + paclitaxel + cisplatin	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
placebo+paclitaxel + cisplatin	paclitaxel	Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance
placebo+paclitaxel + cisplatin	cisplatin	Paclitaxel 175mg/m2, Day 1，cisplatin 75mg/m2，Day 1，placebo，Day 2，every 3 weeks, maximum 6 cycles, then placebo maintenance

Primary Outcome Measures

Name	Time	Method
PFS assessed by IRC	approximately 22 months	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
OS	approximately 22 months	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.

Secondary Outcome Measures

Name	Time	Method
PFS assessed by investigators	approximately 22 months	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
6 and 9 month OS rate	approximately 6 and 9 months	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.
ORR	approximately 22 months	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
DCR	approximately 22 months	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
DoR	approximately 22 months	based on response evaluation criteria in solid tumors 1.1 (RECIST 1.1)
AE	approximately 22 months	adverse events

Trial Locations

Locations (1)

Cancer Center of Sun-Yat Sen University (CCSYSU); 🇨🇳 Guangzhou, Guangdong, China