Using chemotherapy with cetuximab to treat unresectable liver metastasis from right-sided colon cancer

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 observational study aims to evaluate the efficacy and safety of adding cetuximab to doublet or triplet chemotherapy for patients with right-sided BRAF/RAS wild-type colorectal liver metastases. It focuses on assessing the radical resection rate (R0) as the primary endpoint, alongside secondary endpoints such as response rate, no evidence of disease (NED), depth of remission, early tumor shrinkage, and progression-free survival. The study is designed to address the challenges and controversies surrounding optimal conversion therapies for this specific subgroup of colorectal cancer patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent obtained before any study specific procedures. Subjects must be able to understand and willing to sign a written informed consent;
* Male or female subjects \> 18 years \< 75 of age;
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ;
* Life expectancy of more than 3 months;
* Patients with pathologically confirmed metastatic colorectal liver metastases with molecular testing RAS/BRAF wild-type, MSS;
* At least one measurable lesion in liver metastases according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.1;
* No previous any systemic anticancer therapy; if received primary tumor surgery and postoperative adjuvant chemotherapy, more than 6 months from the end of the last chemotherapy;
* Liver metastases are initially unresectable, but can have the opportunity to achieve complete resection or NED status with conversion therapy;
* Patients have adequate bone marrow, hepatic and renal function;

Exclusion Criteria:

* Any evidence of extra-hepatic metastases, lymph node (including portal lymph nodes) metastases and primary tumor recurrence.
* The primary tumor cannot be completely resected;
* If the possibility of R0 transformation is achieved, the patient refuses surgery due to non-medical factors.

Where it's running

• Qilu hospital of Shandong University
  Jinan, Shandong, China Recruiting

Study contacts

• Study coordinator: Jing Hao, PhD
• Email: hedi0084@hotmail.com
• Phone: 18560082857

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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.