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TIME in Immunotherapy Combined With nCRT for Rectal Cancer
Sponsor: Peking Union Medical College Hospital
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.
Official title: The Therapeutic and Prognostic Implications of Tumor Immune Microenvironment in The Neoadjuvant Immunotherapy Combined With Chemoradiotherapy for Rectal Cancer
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-12-20
Completion Date
2029-12-01
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
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
Capecitabine
Capecitabine 1650mg/m2/d orally twice-daily, 5 days a week for a total of 5 weeks.
Long-course radiation therapy
45-50 Gy/day, 5 days a week for a total of 5 weeks.
Locations (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China