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Neoadjuvant/Adjuvant AK104 in Microsatellite Instability-high or Mismatch Repair-deficient, Resectable Colon Cancer

NCT07412613 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386

Last updated 2026-04-22

No results posted yet for this study

Summary

This is a randomized, open-label, controlled, multicenter phase 3 study. All patients are resectable microsatellite instability-high (MSI-H) or mismatch repair-deficient (dMMR) colon cancer. The purpose of this study is to evaluate the efficacy and safety of neoadjuvant/adjuvant treatment of AK104 (Cadonilimab) versus adjuvant chemotherapy in patients with resectable MSI-H/dMMR colon cancer.

Conditions

  • Resectable Colon Cancer
  • MSI-H/dMMR Colorectal Cancer

Interventions

DRUG

Cadonilimab (AK104)

Anti-PD-1/CTLA-4 tetrameric bispecific antibody

DRUG

Oxaliplatin

Intravenous

DRUG

Capecitabine

Oral

DRUG

5- Fluorouracil

Intravenous

DRUG

Calcium Folinate

Intravenous

Sponsors & Collaborators

Principal Investigators

  • Ruihua Xu, PhD · Sun Yat-Sen University Cancer Center

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
2026-04-15
Primary Completion
2030-06-15
Completion
2031-03-15

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT07412613 on ClinicalTrials.gov