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

NCT03691090 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 596

Last updated 2022-12-07

No results posted yet for this study

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.

Conditions

  • Advanced Esophageal Cancer

Interventions

DRUG

SHR-1210

SHR-1210 200mg

DRUG

Placebo

Placebo

DRUG

paclitaxel

paclitaxel 175mg/m2

DRUG

cisplatin

cisplatin 75mg/m2

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ruihua Xu · Cancer Center of Sun-Yat Sen University (CCSYSU)

  • Qing Yang · Jiangsu HengRui Medicine Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2020-10-30
Completion
2022-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03691090 on ClinicalTrials.gov