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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04525313

Enrollment

116

Registered

2020-08-25

Start date

2020-08-31

Completion date

2022-12-31

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Liver Metastases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 79 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
response rate	6 months	response rate will be assessed by local MDT every two months

Secondary

Measure	Time frame	Description
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

Contacts

Primary ContactJianmin Xu

xujmin@aiiyun.com+8613501984869

Outcome results