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

NCT06490913 | Not Yet Recruiting Phase 2

• 1 other identifier: CRC-01
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  every 2 weeks

Secondary Outcomes (1)

• overall survival

  Around 2 years

Study Arms (1)

cetuximab+chemotherapy

EXPERIMENTAL

XELOX 1 cycle；cetuximab+chemotherapy up to 12 cycles

Drug: Capecitabine; Drug: oxaliplatin; Drug: Cetuximab; Drug: Leucovorin; Drug: 5-FU

Interventions

Capecitabine DRUG

1000mg/m2, bid, d1-d14，q3w，1cycle

cetuximab+chemotherapy

Oxaliplatin DRUG

130mg/m2, ivgtt, d1，q3w，1cycle

cetuximab+chemotherapy

Cetuximab DRUG

cetuximab 500mg/m2, q2w

cetuximab+chemotherapy

Leucovorin DRUG

400mg/m2, d1,q2w

cetuximab+chemotherapy

5-FU DRUG

400mg/m2，d1,q2w

cetuximab+chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;
• Received any anti-tumor therapy and participated in other clinical studies within 4 weeks before enrollment.

Sponsors & Collaborators

• Fujian Cancer Hospital: lead

MeSH Terms

Interventions

Capecitabine; Oxaliplatin; Cetuximab; Leucovorin; Fluorouracil

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Central Study Contacts

Li hui, bachelor

CONTACT

13600855801; Lihui7701@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 8, 2024
• Study Start: November 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 8, 2024

Record last verified: 2024-07