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

First-line Treatment of mCapOX Plus Cetuximab Versus mFOLFOX6 Plus Cetuximab for Metastatic Left-sided CRC Patients With Wild-type RAS/BRAF Genes: a Multicenter, Randomised, Phase 2 Study

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.

Study Overview

• Status: Recruiting
• Conditions: Colo-rectal Cancer; Capecitabine; Cetuximab
• Intervention / Treatment: Drug: mCapOX plus cetuximab; Drug: mFOLFOX6 plus cetuximab

Detailed Description

The patients, who meet the inclusion criteria and have signed the informed consent, will be randomly assigned (1:1 ratio) to receive mCapOX plus cetuximab regimen (arm A) and mFOLFOX6 plus cetuximab regimen (arm B).

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xiaofen Li, M.D.; Phone Number: +86-28-85422589; Email: lxf0827@163.com

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Recruiting
      • West China Hospital of Sichuan University
      • Contact: Xiaofen Li, M.D.; Phone Number: +86-28-85422589; Email: lxf0827@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.
• Patients with other serious diseases that the investigator considers not suitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; mCapOX (capecitabine+oxaliplatin) plus cetuximab	Drug: mCapOX plus cetuximab; capecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w
Active Comparator: Arm B; mFOLFOX6 (fluorouracil+leucovorin+oxaliplatin) plus cetuximab	Drug: mFOLFOX6 plus cetuximab; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival	Progression free survival is defined as the period from randomization to disease progress or death.	up to 3 years
Objective response rate	The rate of complete response and partial response	6 months
Disease control rate	The rate of complete response, partial response and stable disease.	6 months
Overall survival	Overall survial is defined as the period from randomization to death.	up to 4 years
Adverse event rate	The rate of adverse event after treatment	3 years

Collaborators and Investigators

• Sponsor: West China Hospital
• Collaborators: First Affiliated Hospital of Chongqing Medical University
• Investigators: Principal Investigator: Meng Qiu, M.D., West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2021
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 7, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cetuximab
• Other Study ID Numbers: 20210602

Drug and device information, study documents

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