The Prediction Model of Avastin Plus Chemotherapy in Unresectable Ras Mutant CRLM Patients

• Conditions: Liver Metastases; Colorectal Cancer

• Registration Number: NCT04525313
• Lead Sponsor: Fudan University

Brief Summary

establishment and validation of the prediction model of avastin plus chemotherapy as first line treatment in simultaneous ras mutant unresectable CRLM patients

Detailed Description

Ras mutant unresectable CRLM patients with primary tumor resection followed by avastin in combination with chemotherapy were included in this study. The tumor response was assessed by local MDT group. Based on tumor response, 58 CRLM patients were classified into two groups (CR+PR vs SD+PD). Primary samples of the two group patients will be sequenced by mass spectrum. After MS sequencing, a prediction model will be estimated. Another 58 CRLM patients will be inclued for validation of the prediction model.

Study Timeline

• Status Verified: 2020-08
• Study Start: 2020-08
• Study First Submitted: 2020-08-21
• Study First Submitted QC: 2020-08-23
• Last Update Submitted: 2020-08-23
• Study First Posted: 2020-08-25
• Last Update Posted: 2020-08-25
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

age 18-75 years, histologically proven colorectal adenocarcinoma, with liver-dominant disease, a life expectancy of > 3 months, ras mutation, unresectable simultaneous liver metastasis, ECOG 0-1, written informed consent for participation in the trial.

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Exclusion Criteria

patients with known hypersensitivity reactions to any of the components of the study treatments, pregnancy or breast-feeding, accepted chemotherapy, radiotherapy and target therapy before primary tumor resection, other previous malignancy within 5 years, known drug abuse/alcohol abuse, ECOG>1, legal incapacity or limited legal capacity.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
response rate	6 months	response rate will be assessed by local MDT every two months

Secondary Outcome Measures

Name	Time	Method
overall survival	3 years	overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment
progression free survival	3 years	progression free survival will be assessed by local MDT every two months during treatment, and telephone follow-up every three month after treatment