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

NCT05815303 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-04-18

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-29
Primary Completion
2025-03-31
Completion
2026-03-31

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815303 on ClinicalTrials.gov