RecruitingPhase 2NCT05815303

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


Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

92 participants

Start Date

Mar 29, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two treatment approaches before surgery for people with locally advanced rectal cancer: the standard chemotherapy regimen (XELOX) alone versus XELOX combined with cadonilimab, an immunotherapy drug. Researchers want to find out if adding immunotherapy shrinks the tumor more effectively before surgery. **You may be eligible if...** - You are 18 or older - You have been diagnosed with rectal cancer located 5–15 cm from the anal opening, and it is locally advanced - Your tumor is classified as mismatch repair proficient (pMMR) — a specific lab finding - You have not received any prior treatment - You are in good health (ECOG 0–1) **You may NOT be eligible if...** - Your cancer has spread to distant organs - You have had prior chemotherapy, radiation, or surgery for this cancer - Your blood, kidney, or liver tests are outside normal ranges - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCapecitabine

1000mg/m2 po bid on day 1 to 14, every 21 day

DRUGCadonilimab

10mg/kg iv on day 1, every 21 day

DRUGOxaliplatin

130mg/m2 iv on day 1, every 21 day


Locations(1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

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NCT05815303


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