NCT07332221

Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter Clinical Trial

Application of Toripalimab as Adjuvant Therapy After Esophageal Cancer Surgery: A Multicenter, Phase III Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 435 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, multicenter, multi-cohort Phase III clinical trial. It primarily enrolls high-risk recurrent esophageal cancer patients who have undergone R0 resection after neoadjuvant chemoimmunotherapy. Eligible patients are stratified based on pathological lymph node status and receive either toripalimab monotherapy as maintenance treatment or clinical observation only.

Detailed description

This is a prospective, multicenter, multi-cohort Phase III clinical study. It primarily enrolls high-risk recurrent esophageal cancer patients who have achieved R0 resection after undergoing neoadjuvant chemoimmunotherapy. Eligible patients are stratified into two cohorts based on pathological lymph node status: Cohort A (ypN+ cohort) and Cohort B (ypN0 cohort). Interventions and Treatment Schedule Cohort A (ypN+ cohort): Patients receive toripalimab monotherapy as consolidation/maintenance treatment. Dosage: Toripalimab 240 mg. Administration: Every 3 weeks per cycle. Duration: Up to 17 cycles, with a total treatment period not exceeding one year. Cohort B (ypN0 cohort): Patients are randomized 1:1 into two groups: Experimental Group: Receives toripalimab monotherapy as consolidation/maintenance treatment (same dosage and schedule as Cohort A). Control Group: Undergoes postoperative observation only. Follow-up and Assessments Disease Evaluation: Assessments including chest + upper abdominal contrast-enhanced CT + neck contrast-enhanced CT are performed every 3 months for 2 years, then every 6 months until the 5th year. PET-CT, chest MRI, gastroscopy, and bronchoscopy are conducted when necessary. Safety Monitoring: Adverse events (AEs) are monitored throughout the study and graded according to CTCAE v5.0. Safety follow-up is performed for all subjects who received the study treatment, including those who discontinued early.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab monotherapy	Toripalimab monotherapy as maintenance treatment

Timeline

• Start date: 2026-01-20
• Primary completion: 2029-10-01
• Completion: 2031-10-01
• First posted: 2026-01-12
• Last updated: 2026-01-12