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

NCT ID: NCT04525313

Last Updated: 2020-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-31

Study Completion Date

2022-12-31

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.

Conditions

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Colorectal Cancer Liver Metastases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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training set

58 unresectable simutaneous CRLM patients with ras mutation accepted Avastin plus chemotherapy treatment after primary tumor resection between 2013.01 and 2017.12.

No interventions assigned to this group

validation set

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

No interventions assigned to this group

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Jianmin Xu

Role: CONTACT

+8613501984869 ext. +8613501984869

Other Identifiers

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BECOME1

Identifier Type: -

Identifier Source: org_study_id

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