Comparing Cadonilimab with FOLFOX to FOLFOX alone for advanced colorectal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of combining Cadonilimab with the FOLFOX chemotherapy regimen compared to using FOLFOX alone in patients with locally advanced colorectal cancer that is proficient in mismatch repair (pMMR) or microsatellite stable (MSS). Participants will be randomly assigned to receive one of the two treatment regimens, and the study will assess the rates of pathological complete response as well as survival outcomes. The trial is designed as a prospective, randomized, open-label study conducted at a single center, focusing on patients who have not received prior systemic therapy or radiotherapy for their condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age 18 to 75, no gender restrictions;
* Histologically or cytologically confirmed colorectal adenocarcinoma;
* Clinically diagnosed as stage II/III colorectal cancer based on CT and/or MRI (according to the 8th edition of AJCC staging);
* Sufficient tumor tissue specimens for mismatch repair protein expression or microsatellite instability testing;
* No prior systemic drug therapy and/or radiotherapy for colorectal adenocarcinoma;
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
* Normal major organ function, no severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency diseases (see protocol for details);
* Voluntary participation in this study and signed informed consent form;
* Expected good compliance to complete the study treatment, follow-up for efficacy and adverse reactions according to the protocol requirements.

Exclusion Criteria:

* Pathology is other malignant tumors besides adenocarcinoma, such as squamous cell carcinoma, gastrointestinal stromal tumor, melanoma, etc.;
* Within 5 years prior to the first use of investigational drug, diagnosed with other malignant tumors, excluding effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ cervical cancer and/or breast cancer effectively removed;
* Any distant metastatic colorectal adenocarcinoma (according to AJCC 8th edition staging, determined as M1), including but not limited to distant lymph node metastasis, liver metastasis, lung metastasis, intraperitoneal dissemination, or malignant peritoneal effusion;
* Various severe underlying diseases and autoimmune diseases (see protocol for details);
* Unable to control recurrent bleeding or subjects who received blood transfusion within 2 weeks prior to the first use of investigational drug;
* Any other circumstances where the investigator believes it may increase the risk associated with participating in the study, the administration of the investigational drug, or affect the subject's ability to receive the investigational drug and the reliability of the study results.

Where it's running

• Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Recruiting
• Sun Yat-sen University Cancer Center
  Guangzhou, Guangdong, China Recruiting
• Qilu Hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Principal investigator: Qian Liu — vice director of colorectal surgery dept.
• Study coordinator: Qian Liu
• Email: fcwpumch@163.com
• Phone: +8618610506948

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.