NCT04509635

Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

A Single-centre, Prospective, Randomised, Controlled, Unblinded, Parallel-group Trial of Cetuximab Plus Chemotherapy Versus Chemotherapy Alone for Colorectal Cancer Liver Metastasis With Progression After First-line Treatment of Cetuximab

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

For patients with unresectable colorectal cancer liver metastases, preclinical studies have shown that after the resistance of cetuximab, the treatment sensitivity can be restored by stopping cetuximab for a period of time. This is called the cetuximab re-challenge. And the circulating tumor DNA (ctDNA) test is reported a biomarker for the efficacy of cetuximab rechallenge. However, there is still no randomized controlled trial for verification. This study aims at patients after the first-line treatment of cetuximab has progressed. After the second-line non-cetuximab treatment has progressed, the effects of re-application of combined with cetuximab and chemotherapy alone are compared to verify the re-challenge effect.

Detailed description

Patients with colorectal cancer liver metastases were RAS wild type, received first-line cetuximab plus chemotherapy. After first-line progression, second-line non-cetuximab treatment were used. After second-line progression, ctDNA is test, and patients with RAS wild-type are enrolled in the study to compare cetuximab plus chemotherapy vs. chemotherapy alone as third-line treatment. Treatment will continue until disease progression or unacceptable toxic effects. The primary endpoint is the disease control rate，which will be assessed by local multidisciplinary team with the use of contrast-enhanced CT or MRI after 4 cycles and then every other 4 cycles up to 12 cycles.

Conditions

• Colorectal Cancer
• Liver Metastases
• Cetuximab

Interventions

Type	Name	Description
DRUG	Cetuximab	Cetuximab is used for only patients with ctDNA test RAS wild type.
DRUG	Chemotherapy	The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.

Timeline

• Start date: 2020-09-01
• Primary completion: 2022-08-31
• Completion: 2024-08-31
• First posted: 2020-08-12
• Last updated: 2020-08-12