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

Comparison of Immune Checkpint Inhibitors Combined With Chemotherapy Versus Chemotherapy Alone in the Neoadjuvant Treatment of Locally Advanced Colorectal Cancer: a Randomized, Open-label, Single-center Phase II Clinical Study

This study is testing whether adding a new drug called Cadonilimab to the FOLFOX chemotherapy can help people with advanced colorectal cancer do better than just using FOLFOX alone.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 3 sites (Beijing, Beijing Municipality and 2 other locations)
• Trial ID: NCT06154538 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with stage II/III colorectal adenocarcinoma that is pMMR or MSS.

Not a fit: Patients with prior systemic therapy or radiotherapy for colorectal adenocarcinoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective neoadjuvant treatment option for patients with locally advanced colorectal cancer.

How similar studies have performed: Other studies have shown promising results with similar combination therapies, indicating potential for success in this approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 2 other locations

• 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

Conditions Locally Advanced Colorectal Carcinoma