Status:
NOT_YET_RECRUITING
Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes
Lead Sponsor:
Fujian Cancer Hospital
Conditions:
Liver Metastases of Colorectal Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 wit...
Eligibility Criteria
Inclusion
- 18-75 years (including 18 and 75 years);
- ECOG PS 0 or 1;
- Colorectal cancer diagnosed histologically and/or cytologically with metastatic or recurrent lesions that are not curable with surgery;
- Patients with liver metastases of RAS wild-type colorectal cancer who have not received prior treatment;
- At least one measurable lesion as defined in RECIST version 1.1;
- 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;
- Have fully understood the study and voluntarily signed the informed consent.
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06490913
Start Date
November 1 2024
End Date
December 31 2025
Last Update
July 8 2024
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