TIME in Immunotherapy Combined With nCRT for Rectal Cancer

Sex: All

Ages: 18 Years – 75 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 100

Sponsor: Peking Union Medical College Hospital

Location: Peking Union Medical College Hospital Beijing Beijing Municipality

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.

Eligibility Criteria

Inclusion Criteria: 1. Age ≥ 18 years and ≤75 years on the day of signing informed consent. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 3. Histologically proven rectal adenocarcinoma. 4. \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05507112). StuddyBuddy aggregates publicly available trial information.