NCT05637268

Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Esophageal Squamous Cell Carcinoma

Carrelizumab Combined With Chemotherapy for Adjuvant Therapy of Node-positive Thoracic Esophageal Squamous Cell Carcinoma: a One-arm, Phase II Clinical Study

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-arm, open, exploratory clinical study to evaluate the efficacy and safety of camrelizumab combined with chemotherapy for adjuvant treatment of nodal positive thoracic esophageal squamous cell carcinoma.

Detailed description

Treatment with carrilizumab combined with chemotherapy was planned for 4 to 6 cycles, after which carrilizumab monotherapy was maintained until disease progression, unacceptable toxicity, or patient withdrawal. vial card Rayleigh bead sheet resistance: intravenous drip, fixed dose of 200 mg, with 30 minutes to an intravenous drip (The overall infusion time including the flushing time shall be no less than 20 minutes, no longer than 60 minutes), Day 1, every repeat once every 2 weeks. paclitaxel: 150 mg/m2, intravenous drip for 30 minutes, 1 day, every 14 days for a cycle. cisplatin: 50 mg/m2, 2 days, every 14 days for a cycle. A total of 4 to 6 cycles, after carrilizumab maintenance treatment for one year.

Conditions

• Esophagus Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab	Camrelizumab 200mg iv q2w
DRUG	Paclitaxel	150mg/m² iv d1 q2w
DRUG	Cisplatin	50 mg/m² iv d2 q2w

Timeline

• Start date: 2020-11-26
• Primary completion: 2024-06-01
• Completion: 2025-06-01
• First posted: 2022-12-05
• Last updated: 2022-12-05

Locations

1 site across 1 country: China