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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04525313
• Other study ID #: BECOME1
• Status: Not yet recruiting
• Start date: August 2020
• Est. completion date: December 2022

Study information

• Verified date: August 2020
• Source: Fudan University
• Contact: Jianmin Xu
• Phone: +8613501984869
• Email: xujmin[@]aiiyun.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 116
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Metastases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response rate	response rate will be assessed by local MDT every two months	6 months
Secondary	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
Secondary	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