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ACTIVE NOT RECRUITING
NCT07127497
PHASE2

Clinical Study on the Safety and Relationship of Sintilimab Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Rectal Adenocarcinoma

Sponsor: The First Affiliated Hospital of Anhui Medical University

View on ClinicalTrials.gov

Summary

This study is designed as a single-center, phase II exploratory clinical trial to evaluate the pathological response rate and safety of sintilimab (PD-1 inhibitor) combined with XELOX regimen (oxaliplatin + capecitabine) for neoadjuvant treatment of LARC. The study focuses on the pMMR/MSS patient population and attempts to provide a new treatment option for patients who cannot tolerate radiotherapy or need to preserve organ function.

Official title: Safety and Efficacy Evaluation of Neoadjuvant Chemotherapy Without Radiotherapy Combined With Sintilimab for Locally Advanced Rectal Cancer: Short-term Results of a Single-arm Phase 2 Trial

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2022-06-01

Completion Date

2028-10-01

Last Updated

2025-11-21

Healthy Volunteers

No

Interventions

BIOLOGICAL

Sintilimab combined with XELOX

Sintilimab (3 mg/kg, IV, qd for patients with body weight \< 60 kg; 200 mg, IV, qd for patients with body weight ≥ 60 kg) combined with XELOX (oxaliplatin 130 mg/m2, IV, qd + capecitabine 1000 mg/m2, bid, d1 - d14, q21d) for 2-4 courses

Locations (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China