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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 end point is the rate of pathological complete response (pCR). 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
2022-09-20
Completion Date
2029-12-01
Last Updated
2022-09-21
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.