NCT05507112: TIME in Immunotherapy Combined With nCRT for Rectal Cancer

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 endpoint is the complete response rate, defined as the proportion of patients who achieve pathological complete response (pCR) or clinical complete response (cCR) without evidence of distant metastasis on post-treatment or preoperative assessment. The long-term prognosis and adverse effects will also be evaluated and analyzed.

Timeline

Start: 2022-12-20
Primary completion: 2025-05-30
Completion: 2029-12-01

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tislelizumab	Monoclonal antibody	200 mg	Intravenous
Background	Capecitabine	Small molecule	1650 mg/m2	Oral

Indications

No indication recorded.