Cadonilimab (AK104) Combined With Chemotherapy and Bevacizumab as First-line Treatment for RAS Mutated or Right Sided-metastatic MSS Colorectal Cancer

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCaigang Liu

About this trial

The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) combined with chemotherapy and bevacizumab as first-line treatment for patients with RAS mutated or right sided-metastatic MSS colorectal cancer

Eligibility criteria

Qualifiers

Able to understand and voluntarily sign a written informed consent form, which must be signed before the designated research procedures required for the study are carried out.

Age at the time of signing the Informed Consent Form (ICF) is ≥ 18 years old and ≤ 75 years old, both male and female.

The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.

The expected survival period is ≥ 3 months.

Disqualifiers

Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, or CTLA-4 monoclonal antibody.

The tumor tissue was found to be dMMR or MSI-H

Received palliative local treatment within the first 2 weeks of randomization; Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within the first 2 weeks of randomization; In the first 2 weeks of randomization, they received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications.

Currently participating in another clinical study, unless it is an observational, non-interventional clinical study, or a follow-up period of an intervention study.

Trial design

Treatments tested in this trial

  • Cadonilimab (AK104) combined with chemotherapy and bevacizumab

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

Caigang Liu

Lead sponsor

Shengjing Hospital

Sponsor institution