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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Cetuximab is used for only patients with ctDNA test RAS wild type.
The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.
disease control rate
According to the RECIST v.1.1, the disease control rate (DCR) is the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD), evaluated by radiology (CT, MRI, etc.).
Time frame: 2 years
objective response rate
According to the RECIST v.1.1, the disease control rate (DCR) is the proportion of patients with complete response (CR) and partial response (PR), evaluated by radiology (CT, MRI, etc.).
Time frame: 2 years
progression-free survival
The period from the first day of treatment to the date of disease progression (PD) or to death.
Time frame: 2 years
overall survival
The period from the first day of treatment to the date of death.
Time frame: 2 years
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