Multimodal Model for Efficacy Prediction Cetuximab in Colorectal Cancer Liver Metastasis Patient

NCT05873972 | Unknown

• 1 other identifier: CRC-MULTIMODAL-02 RESEARCH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

Establishment and validation of the deep learning model of Cetuximab efficacy in simultaneous RAS wild unresectable CRLM patients

Conditions

Colorectal Cancer Liver Metastases

Outcome Measures

Primary Outcomes (1)

• response rate

  response rate will be assessed by local MDT

  6 months

Secondary Outcomes (2)

• progression free survival

  3 years

• overall survival

  3 years

Study Arms (2)

ARM A

ACTIVE COMPARATOR

Chemotherapy regimens are determined based on the clinical experience of specialists

Drug: Cetuximab

ARM B

EXPERIMENTAL

Chemotherapy regimens are determined based on the multimodal deep learning signature

Drug: Cetuximab

Interventions

Cetuximab DRUG

AEM A：The specialist's decision to add cetuximab to chemotherapy will be based on their own judgment ARM B：The patient's CT imaging,genetic mutation information were input into the signature, and the FOLFOX+cetuximab regimen was selected when the output label was 1. FOLFOX+bevacizumab chemotherapy regimen was selected when the output label was 0

ARM A; ARM B

Eligibility Criteria

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

You may qualify if:

• Age 18-75 years;
• Histologically proven colorectal adenocarcinoma;
• Simultaneous liver-limited metastases;
• Initially unresectable liver metastases determined by a local MDT;
• Life expectancy of \> 6 months;
• RAS and BRAF V600E wild-type;
• ECOG 0-1;
• Available CT imaging before treatment.

You may not qualify if:

• Previous systemic treatment for metastatic disease;
• Previous surgery for metastatic disease;
• Extrahepatic metastases;
• Unresectable primary tumor;
• Major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, CVA) within 12 months before randomisation;
• Acute or subacute intestinal obstruction;
• Second primary malignancy within the past 5 years;
• Drug or alcohol abuse;
• No legal capacity or limited legal capacity;
• Uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs;

Sponsors & Collaborators

• Fudan University: lead

Study Sites (2)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Zhongshan hosptial, Fudan University

Shanghai, 200032, China

Location

MeSH Terms

Interventions

Cetuximab

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jianmin Xu, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianmin Xu, MD

CONTACT

+86-021-64041990; xujmin@aliyun.com

Wenju Chang, MD

CONTACT

+86-021-64041990; chang.wenju@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Colorectal Surgery

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: May 24, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 24, 2023

Record last verified: 2022-06

Locations

CN (2)