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

Doublet or Triplet Chemotherapy With Cetuximab as Conversion Therapy in RAS/BRAF Wild Type Unresectable Liver Metastasis Right-sided Colon Cancer With Curative Intent：Multi-center, Ambispective Observational Trial

This study is testing if adding cetuximab to standard chemotherapy can help people with right-sided colon cancer that has spread to the liver get better and possibly have surgery to remove their tumors.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qilu Hospital of Shandong University (other)
• Drugs / interventions: chemotherapy, cetuximab
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06322147 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with unresectable right-sided colorectal liver metastases that are RAS/BRAF wild-type and have not received prior systemic anticancer therapy.

Not a fit: Patients with left-sided colorectal liver metastases or those who have previously received systemic anticancer therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve the chances of achieving curative surgery for patients with unresectable liver metastases from right-sided colon cancer.

How similar studies have performed: While there is limited data on the specific approach for right-sided colorectal liver metastases, similar studies have shown promise in using cetuximab with chemotherapy for other colorectal cancer subtypes.

Eligibility criteria

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 this trial is running

Jinan, Shandong

• Qilu hospital of Shandong University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Jing Hao, PhD

Conditions: Colon Cancer