NCT03817658

A Phase II Study of SHR-1210 vs Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Locally Advanced ESCC

A Phase II Clinical Trial of Anti-PD-1 Antibody SHR-1210 Versus Placebo as Consolidation Chemotherapy After Radical Concurrent Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 725 (estimated)
• Sponsor: The First Affiliated Hospital of Zhengzhou University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.

Detailed description

In China, the incidence of esophageal cancer has declined in recent years, but the mortality rate has been ranked fourth. Morbidity and mortality were ranked sixth and fourth in all malignancies, respectively. Therefore, esophageal cancer has always been a major malignant tumor that threatens the health of our residents. We designed a multicenter, randomized, double-blind, open-label phase II clinical trial of anti-PD-1 antibody SHR-1210 versus placebo as consolidation chemotherapy (CCT) after radical concurrent chemoradiotherapy for unresectable locally advanced esophageal squamous cell carcinoma (ESCC).The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 vs placebo as consolidation chemotherapy after radical concurrent chemoradiotherapy for unresectable locally advanced ESCC.

Conditions

• Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	SHR-1210	First stage： Concurrent chemoradiotherapy: Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。 Second stage: SHR-1210 was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight \<50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months.
DRUG	Placebo	First stage： Concurrent chemoradiotherapy: Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。 Second stage: Placebo was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight \<50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-10-01
• Completion: 2021-10-01
• First posted: 2019-01-25
• Last updated: 2019-01-25

Locations

1 site across 1 country: China