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

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

Detailed Description
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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.

Official Title
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The Prediction Model of Avastin Plus Chemotherapy as First Line Treatment in Unresectable Ras Mutant Colorectal Liver Metastase (CRLM) Patients

Conditions
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Colorectal Cancer, Liver Metastases

Participation Criteria
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Eligibility Criteria
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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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| training set<br>58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2013.01 and 2017.12. | |
| validation set<br>another 58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2018.01 and 2022.12. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response rate | response rate will be assessed by local MDT every two months | 6 months | 

Secondary Outcome Measures

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