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

Chemotherapy Plus EGFR Monoclonal Antibody in Patients With Liver Metastases From Colorectal Cancer With ctDNA Superselective Negative Genes：a Phase II Single-arm Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Metastases of Colorectal Cancer
• Intervention / Treatment: Drug: Capecitabine; Drug: oxaliplatin; Drug: Cetuximab; Drug: Leucovorin; Drug: 5-FU; Drug: Oxaliplatin

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Li hui, bachelor; Phone Number: 86 13600855801; Email: Lihui7701@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cetuximab+chemotherapy; XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles	Drug: Capecitabine; 1000mg/m2, bid, d1-d14，q3w，1cycle; Drug: oxaliplatin; 130mg/m2, ivgtt, d1，q3w，1cycle; Drug: Cetuximab; cetuximab 500mg/m2, q2w; Drug: Leucovorin; 400mg/m2, d1,q2w; Drug: 5-FU; 400mg/m2，d1,q2w

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate	every 2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival	Around 2 years

Collaborators and Investigators

• Sponsor: Fujian Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: July 1, 2024
• First Submitted That Met QC Criteria: July 1, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 1, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Liver Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Liver Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Protective Agents; Antineoplastic Agents, Immunological; Micronutrients; Vitamins; Antidotes; Vitamin B Complex; Capecitabine; Oxaliplatin; Leucovorin; Cetuximab
• Other Study ID Numbers: CRC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No