Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis

• Status: Not yet recruiting
• Trial end date: 2024-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fudan University
• Treatments: Cetuximab

Criteria

Inclusion Criteria:

1. Primary tumour was histologically confirmed colorectal adenocarcinoma;

2. Clinical or radiological evidence of non-resectable liver metastases;

3. With at least one measurable tumor;

4. Received first-line cetuximab (RAS gene wild type) treatment and progressed

5. Received second-line non-cetuximab treatment and progressed

6. Received circulating tumor DNA test and has RAS gene wild type status;

7. Performance status (ECOG) 0~1

8. A life expectancy of ≥ 3 months

9. Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)

10. Adequate hepatic and renal function: Serum bilirubin≤1.5 x upper limit of normal (ULN), alkaline phosphatase ≤5x ULN, and serum transaminase (either aspartate transaminase (AST) or alanine transaminase (ALT)) ≤ 5 x ULN(within 1 week prior to randomization);

11. Written informed consent for participation in the trial.

Exclusion Criteria:

1. Patients with known hypersensitivity reactions to any of the components of the study treatments.

2. Acute or sub-acute intestinal occlusion

3. Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding

4. Other previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix Known drug abuse/ alcohol abuse

5. Legal incapacity or limited legal capacity

6. Pre-existing peripheral neuropathy.