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

Fudan University

Status: Not yet enrolling

Conditions: Colorectal Cancer Liver Metastases

Treatments: Drug: Cetuximab

Study type: Interventional

Funder types: Other

Identifiers

NCT05873972

CRC-MULTIMODAL-02 RESEARCH

Details and patient eligibility

About

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

Full description

Ras wild unresectable CRLM patients with primary tumor resection followed by Cetuximab in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, almost 100 CRLM patients were classified into two groups (Clinician drived regimen vs Multi-omics model drived regimen). They will be the prospective cohort to validate our deep learning model for predicting Cetuximab efficacy.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

ARM A

Active Comparator group

Description:

Chemotherapy regimens are determined based on the clinical experience of specialists

Treatment:

Drug: Cetuximab

ARM B

Experimental group

Description:

Chemotherapy regimens are determined based on the multimodal deep learning signature

Treatment:

Drug: Cetuximab