Status:
UNKNOWN
Cetuximab Re-challenge for Colorectal Cancer Liver Metastasis
Lead Sponsor:
Fudan University
Conditions:
Colorectal Cancer
Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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 cetuxima...
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...
Eligibility Criteria
Inclusion
- Primary tumour was histologically confirmed colorectal adenocarcinoma;
- Clinical or radiological evidence of non-resectable liver metastases;
- With at least one measurable tumor;
- Received first-line cetuximab (RAS gene wild type) treatment and progressed
- Received second-line non-cetuximab treatment and progressed
- Received circulating tumor DNA test and has RAS gene wild type status;
- Performance status (ECOG) 0\~1
- A life expectancy of ≥ 3 months
- Adequate hematological function: Neutrophils≥1.5 x109/l and platelet count≥100 x109/l; Hb ≥9g/dl (within 1 week prior to randomization)
- 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);
- Written informed consent for participation in the trial.
Exclusion
- Patients with known hypersensitivity reactions to any of the components of the study treatments.
- Acute or sub-acute intestinal occlusion
- Pregnancy (absence confirmed by serum/urine β-HCG) or breast-feeding
- 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
- Legal incapacity or limited legal capacity
- Pre-existing peripheral neuropathy.
Key Trial Info
Start Date :
September 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04509635
Start Date
September 1 2020
End Date
August 31 2024
Last Update
August 12 2020
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