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

NCT04525313 | Unknown

• 1 other identifier: BECOME1
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Colorectal Cancer; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• response rate

  response rate will be assessed by local MDT every two months

  6 months

Secondary Outcomes (2)

• overall survival

  3 years

• progression free survival

  3 years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Simultaneous unresectable CRLM patients(ras mutation) with primary tumor resection before Avastin plus chemotherapy as first line treatment

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

primary tumor proteins of CRLM patients before avastin plus chemotherapy treatment will be sequenced by mass spectrum

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Central Study Contacts

Jianmin Xu

CONTACT

+8613501984869; xujmin@aiiyun.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 25, 2020
• Study Start: August 1, 2020
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 25, 2020

Record last verified: 2020-08