NCT04602013

Sintilimab Injection Combined With Concurrent CCRT in Locally Advanced Esophageal Squamous Cell Carcinoma

A Prospective, Multi-center, Single-arm Clinical Study of Sintilimab Injection Combined With Concurrent Radiotherapy and Chemotherapy in the Treatment of Locally Advanced Esophageal Squamous Cell Carcinoma (IMCORT)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: Sichuan Cancer Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the effectiveness and safety of sintilimab combined with cCRT in patients with locally advanced ESCC.

Detailed description

This study evaluated the effectiveness and safety of sintilimab combined with cCRT in patients with locally advanced ESCC. The primary endpoint is PFS. Secondary points contains：ORR、OS、Qol.

Conditions

• Locally Advanced Esophageal Squamous Cell Carcinoma

Interventions

Type	Name	Description
DRUG	Sintilimab	Body weight \<60kg: 3mg/kg IV Q3W; Body weight ≥60kg: 200mg IV Q3W. Every three weeks is a cycle
DRUG	Chemotherapy	Chemotherapy drugs include cisplatin and albumin-bound paclitaxel for injection Paclitaxel for injection (albumin-bound type) dose: 3 dose groups (di=260 mg/m2, di-1=220 mg/m2, di-2=180 mg/m2). Dosing on the first day, one cycle every three weeks, a total of 2 cycles. Cisplatin (25mg/m2 IV D1-3 Q3W)
RADIATION	Radiation Therapy	The total dose is 60-66 Gy, divided into 30-33 times (2.0 Gy/f, 5 f per week).

Timeline

• Start date: 2020-10-11
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2020-10-26
• Last updated: 2020-10-26

Locations

1 site across 1 country: China