NCT05815303

XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for Locally Advanced, pMMR Rectal Cancer

XELOX Combined With Cadonilimab Versus XELOX as Neoadjuvant Treatment for MRF-negative Locally Advanced, pMMR Rectal Cancer: a Randomised, Phase 2 Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a two-arm, open label, randomized phase II clinical study. The aim is to evaluate the safety and efficacy of Cadonilimab (a PD-1/CTLA-4 bispecific antibody) combined with XELOX regimen in pMMR locally advanced rectal cancer during the perioperative period. Eligible patients will receive either Cadonilimab plus XELOX or XELOX alone for 4 cycles before and 4 cycles after surgery. The primary endpoint is the pathological complete response rate.

Conditions

• Rectal Cancer
• MSS

Interventions

Type	Name	Description
DRUG	Cadonilimab	10mg/kg iv on day 1, every 21 day
DRUG	Oxaliplatin	130mg/m2 iv on day 1, every 21 day
DRUG	Capecitabine	1000mg/m2 po bid on day 1 to 14, every 21 day

Timeline

• Start date: 2023-03-29
• Primary completion: 2025-03-01
• Completion: 2026-03-01
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: China