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

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Fudan University

Status

Unknown

Conditions

Liver Metastases
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT04525313
BECOME1

Details and patient eligibility

About

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

Full 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.

Enrollment

116 estimated patients

Sex

All

Ages

18 to 79 years old

Volunteers

No Healthy Volunteers

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.

Trial design

116 participants in 2 patient groups

training set
Description:
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
Description:
another 58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2018.01 and 2022.12.

Trial contacts and locations

0

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Central trial contact

Jianmin Xu

Data sourced from clinicaltrials.gov

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