Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes

Fujian Provincial Cancer Hospital

Status and phase

Not yet enrolling

Phase 2

Conditions

Liver Metastases of Colorectal Cancer

Treatments

Drug: Capecitabine

Drug: Cetuximab

Drug: 5-FU

Drug: oxaliplatin

Drug: Leucovorin

Drug: Oxaliplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT06490913

CRC-01

Details and patient eligibility

About

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.

Enrollment

33 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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:
1. 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;
2. 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 criteria

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.