NCT05507112

TIME in Immunotherapy Combined With nCRT for Rectal Cancer

The Therapeutic and Prognostic Implications of Tumor Immune Microenvironment in The Neoadjuvant Immunotherapy Combined With Chemoradiotherapy for Rectal Cancer

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, prospective phase II clinical trial to evaluate the therapeutic and prognostic implications of tumor immune microenvironment in the neoadjuvant immunotherapy combined with chemoradiotherapy for patients with rectal cancer. A total of 100 patients will be enrolled in this trial. The primary end point is the rate of pathological complete response (pCR). The long-term prognosis and adverse effects will also be evaluated and analyzed.

Detailed description

Objectives: 1. To clarify the efficacy and safety of combined therapy for locally advanced rectal cancer (LARC) patients and verify the efficacy and safety of neoadjuvant immunotherapy for dMMR/MSI-H LARC patients. 2. To clarify the effect of nCRT on TIME for rectal cancer, and the further effect of adding Immunotherapy. 3. To verify the feasibility of predicting the efficacy of combined therapy by the infiltration level of CD8+ PD1+ TILs in tumor tissue before treatment in pMMR/MSS LARC patients and explore the comprehensive prediction index of the efficacy of combined therapy for LARC patients. 4. To clarify the potential mechanism of immune response or immune escape to neoadjuvant immunotherapy for LARC patients.

Conditions

• Locally Advanced Rectal Cancer

Interventions

Type	Name	Description
DRUG	PD-1 inhibitor	Tislelizumab (3 cycles): 200mg i.v. q3w on day 1 of each cycle, and starting from the second week after the start of radiotherapy
DRUG	Capecitabine	Capecitabine 1650mg/m2/d orally twice-daily, 5 days a week for a total of 5 weeks.
RADIATION	Long-course radiation therapy	45-50 Gy/day, 5 days a week for a total of 5 weeks.

Timeline

• Start date: 2022-09-20
• Primary completion: 2024-07-01
• Completion: 2029-12-01
• First posted: 2022-08-18
• Last updated: 2022-09-21