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

NCT ID: NCT06490913

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-12-31

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.

Conditions

Liver Metastases of Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

cetuximab+chemotherapy

XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles

Group Type: EXPERIMENTAL

Capecitabine

Intervention Type: DRUG

1000mg/m2, bid, d1-d14，q3w，1cycle

oxaliplatin

Intervention Type: DRUG

130mg/m2, ivgtt, d1，q3w，1cycle

Cetuximab

Intervention Type: DRUG

cetuximab 500mg/m2, q2w

Oxaliplatin

Intervention Type: DRUG

85mg/m2, d1,q2w

Leucovorin

Intervention Type: DRUG

400mg/m2, d1,q2w

5-FU

Intervention Type: DRUG

400mg/m2，d1,q2w

Interventions

Capecitabine

1000mg/m2, bid, d1-d14，q3w，1cycle

Intervention Type: DRUG

oxaliplatin

130mg/m2, ivgtt, d1，q3w，1cycle

Intervention Type: DRUG

Cetuximab

cetuximab 500mg/m2, q2w

Intervention Type: DRUG

Oxaliplatin

85mg/m2, d1,q2w

Intervention Type: DRUG

Leucovorin

400mg/m2, d1,q2w

Intervention Type: DRUG

5-FU

400mg/m2，d1,q2w

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Li hui, bachelor

Role: CONTACT

Lihui7701@163.com

13600855801 ext. 86

Other Identifiers

CRC-01

Identifier Type: -

Identifier Source: org_study_id