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NOT YET RECRUITING
NCT05507112
PHASE2

TIME in Immunotherapy Combined With nCRT for Rectal Cancer

Sponsor: Peking Union Medical College Hospital

View on ClinicalTrials.gov

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

Interventions

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.