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drugset / Trial / NCT04663763

Neoadjuvant Short-course Radiotherapy Followed by the Combination of Immunotherapy and Chemotherapy in Locally Advanced Rectal Cancer

NCT04663763 ↗

Phase 2 Unknown 40 enrolled Zhejiang Cancer Hospital
NaSingle-groupOpen-labelTreatment

Summary

This is a single arm, open-label, prospective phase II clinical trial to evaluate the combination of neoadjuvant short-course radiotherapy and immunotherapy (PD-1 antibody) for patients with locally advanced rectal cancer (LARC). A total of 40 patients will be enrolled in this trial to receive 5\*5Gy short-course radiotherapy, followed by 4 cycles of CAPOX chemotherapy and PD-1 antibody. Then they will receive the TME surgery and another 4 cycles of CAPOX chemotherapy. There are two cohorts according to the microsatellite instability status: (1) the micro-satellite stable (MSS) cohort（n=32), (2) the MSI-high cohort (n=8). 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.

Timeline

Start
2020-12-01
Primary completion
2022-12-01
Completion
2025-12-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Capecitabine Small molecule 1000 mg/m2 —
Subject Oxaliplatin Small molecule 130 mg/m2 —
Subject Sintilimab Monoclonal antibody 200 mg Intravenous

Indications

No indication recorded.