NCT06229041

Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 472 (estimated)
• Sponsor: Peking University Cancer Hospital & Institute · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant treatment ±immunotherapy followed by surgery. Researchers will compare neoadjuvant treatment ±immunotherapy to see the PCR rate.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
DRUG	Camrelizumab ＋Immunotherapy	Camrelizumab was used in preoperative treatment.

Timeline

• Start date: 2023-03-29
• Primary completion: 2027-10-01
• Completion: 2029-10-01
• First posted: 2024-01-29
• Last updated: 2024-01-29

Locations

1 site across 1 country: China