First-line mCapOX+Cetuximab vs. mFOLFOX6+Cetuximab for Metastatic Left-sided CRC With Wild-type RAS/BRAF Genes

NCT05022030 | Recruiting Phase 2

• 1 other identifier: 20210602
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, randomized, phase 2 study is conducted to evaluate the efficacy and safety of first line mCapOX plus cetuximab versus mFOLFOX6 plus cetuximab for metastatic left-sided CRC patients with wild-type RAS and BRAF genes.

Conditions

Colo-rectal Cancer; Capecitabine; Cetuximab

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) rate at 9 months

  PFS rate at 9 months is defined as the proportion of patients without PD or death at 9 months after randomization.

  9 months

Secondary Outcomes (5)

• Objective response rate

  6 months

• Disease control rate

  6 months

• Progression free survival

  up to 3 years

• Overall survival

  up to 4 years

• Adverse event rate

  3 years

Study Arms (2)

Arm A

EXPERIMENTAL

mCapOX (capecitabine+oxaliplatin) plus cetuximab

Drug: mCapOX plus cetuximab

Arm B

ACTIVE COMPARATOR

mFOLFOX6 (fluorouracil+leucovorin+oxaliplatin) plus cetuximab

Drug: mFOLFOX6 plus cetuximab

Interventions

mCapOX plus cetuximab DRUG

capecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w

Arm A

mFOLFOX6 plus cetuximab DRUG

oxaliplatin ivgtt 85mg/m2 d1+ leucovorin ivgtt 400mg/m2 d1+ fluorouracil iv bolus 400mg/m2 d1+ fluorouracil 2400mg/m2 continuous infusion for 46h+cetuximab ivgtt 500mg/m2, q2w

Arm B

Eligibility Criteria

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

You may qualify if:

• Able to provide written informed consent and can understand and comply with the requirements of the study;
• Men and women ≥ 18 years of age;
• Patients with histologically or cytologically confirmed metastatic left-sided colorectal adenocarcinoma with wild-type RAS and BRAF genes;
• Presence of at least one evaluable lesion, as defined in RECIST Version 1.1;
• With an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1;
• No palliative first-line chemotherapy, targeted, immunotherapy, or prior platinum-based adjuvant chemotherapy, relapse more than 12 months from the end of adjuvant chemotherapy;
• According to the imaging findings and surgical assessment of initial unresectable, synchronous metastatic colorectal cancer, no serious complications of the primary tumor (obstruction, perforation, massive hemorrhage that cannot be treated in internal medicine, etc.) ;
• Life expectancy of longer than 3 months ( clinical assessment);
• Requirements for lab indicators neutrophils ≥ 1.5 × 109/L, platelets ≥ 75 × 109/L, hemoglobin ≥ 8 g/dL, total bilirubin ≤ 1.5 × upper limit of normal (UNL); ASAT (SGOT) and/or ALAT (SGPT) ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases); alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × UNL if liver metastases, ≤ 10 × UNL if bone metastases); LDH \< 1500 U/L; creatinine clearance (calculated according to Cockcroft and Gault formula) \> 50 mL/min or serum creatinine ≤ 1.5 × UNL;

You may not qualify if:

• Patients with mCRC who were initially resectable with R0 resection or radiofrequency or SBRT were excluded.
• Patients diagnosed with MSI-H or dMMR by PCR or immunohistochemistry
• Hypersensitivity to any therapeutic agent.
• Patients who received adjuvant chemotherapy containing oxaliplatin and fluorouracil within 12 months before entering the study;
• Patients who have failed one or more palliative chemotherapy regimens;
• Patients with uncontrolled hepatitis B virus
• Peripheral neuropathy ≥ CTC grade 2;
• Neurological or psychiatric disorders affecting cognitive performance;
• Patients with central nervous system metastasis could not be controlled with radiotherapy;
• Previous enteritis, chronic diarrhea, or recurrent bowel obstruction; uncontrolled bleeding from internal medicine; bowel perforation
• Uncontrolled concomitant diseases within 6 months before the study, including unstable angina, acute myocardial infarction, cerebrovascular accident, etc.;
• Pregnant or lactating patients, or those of childbearing potential who do not take adequate contraceptive measures;
• History of other malignancies, but no disease-free survival longer than 5 years;
• Patients concurrently receiving other anti-tumor treatment or participating in other interventional clinical trials;
• Patients who are unable to comply with this study for psychological, family or social reasons.

Sponsors & Collaborators

• West China Hospital: lead
• First Affiliated Hospital of Chongqing Medical University: collaborator

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Meng Qiu, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaofen Li, M.D.

CONTACT

+86-28-85422589; lxf0827@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 26, 2021
• Study Start: July 21, 2021
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

CN (1)