Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cetuximab | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Drug | Cetuximab | ALIAS |
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A
- description
- Using treatment of cetuximab plus chemotherapy. Cetuximab: 500 mg/m2 IV over 2 hours, day 1, every 2 weeks. Chemotherapy: detailed regimen is determined by a multi-disciplinary team.
- interventionNames
- Drug: Cetuximab
- Drug: Chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Arm B
- description
- Using treatment of chemotherapy alone. Chemotherapy: detailed regimen is determined by a multi-disciplinary team
- interventionNames
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- disease control rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available