Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes
- Conditions
- Interventions
- Registration Number
- NCT06490913
- Lead Sponsor
- Fujian Cancer Hospital
- Brief Summary
The purpose of this Phase II single-arm study is to prospectively explore the efficacy of chemotherapy plus EGFR inhibitors in patients with liver metastases from total wild-type colorectal cancer with ctDNA superselective negative genes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 33
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18-75 years (including 18 and 75 years);
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ECOG PS 0 or 1;
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Colorectal cancer diagnosed histologically and/or cytologically with metastatic or recurrent lesions that are not curable with surgery;
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Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;
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At least one measurable lesion as defined in RECIST version 1.1;
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Fertile patients must be willing to take highly effective pregnancy avoidance measures during the study period and ≥120 days after the last dosing; Female patients with negative urine or serum pregnancy test results within ≤7 days before the first administration of the study drug;
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Have fully understood the study and voluntarily signed the informed consent.
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Adequate organ and bone marrow function, meeting the following definitions:
- Blood routine (no transfusion, no use of granulocyte colony stimulating factor [G-CSF], no use of other drugs for correction within 14 days before treatment); Absolute neutrophil count (ANC) ≥1.5×109/L; Hemoglobin (HB) ≥9.0 g/dL; Platelet count (PLT) ≥80×109/L;
- Blood biochemistry, serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min; Serum albumin ≥2.8g/dL. Patients with poor nutritional status before neoadjuvant therapy could also be enrolled if they met the criteria through parenteral nutrition. Total bilirubin (TBIL) ≤ 1.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤2.5×ULN;
- Pregnant or lactating women;
- Patients with a known history of allergy to any investigative drug, similar drug, or excipient;
- Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
- Patients with a history of thromboembolism, except thrombosis caused by PICC;
- There are patients with active infection;
- Patients with difficult to control hypertension (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥90mmHg);
- Patients with brain metastases with clinical symptoms or imaging evidence;
- Treatment contraindications exist in combination with other chronic diseases;
- Patients with previous immunotherapy-related myocarditis, pneumonia, colitis, hepatitis, nephritis and other conditions, and the current AE is still ≥ grade 2;
- According to NCI CTCAE version 5.0 evaluation criteria, existing patients with various toxic and side effects caused by previous treatment ≥ grade 2;
- Other conditions that the investigator determined were not suitable for inclusion in the study.
- Received any anti-tumor therapy and participated in other clinical studies within 4 weeks before enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description cetuximab+chemotherapy 5-FU XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles cetuximab+chemotherapy Oxaliplatin XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles cetuximab+chemotherapy Capecitabine XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles cetuximab+chemotherapy Cetuximab XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles cetuximab+chemotherapy Leucovorin XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles
- Primary Outcome Measures
Name Time Method Objective Response Rate every 2 weeks
- Secondary Outcome Measures
Name Time Method overall survival Around 2 years