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Biomarkers for Apatinib and Bevacizumab in Second-line Therapy for Colorectal Cancer(BABST-C)

NCT03743428 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-06-29

No results posted yet for this study

Summary

Bevacizumab, an antibody against vascular endothelial generated factor (VEGF), combined with the fluorouracil-based chemotherapy regimens has been approved in the 1st and 2nd line treatments for metastatic colorectal cancers(mCRC). Other inhibitors of the VEGF pathway, such as Ramucirumab and Aflibercept are also approved in the 2nd line therapy. Apatinib is a small molecule tyrosine kinase inhibitor (TKI), which can highly selectively bind to and strongly block VEGF receptor 2 (VEGFR - 2), resulting in reduced cell migration, proliferation, and tumor microvascular density mediated by VEGF . In this study, the patients who have progressed following or on the first-line oxaliplatin and fluorouracil（5-FU） combined with bevacizumab are randomised into two arms(FOLFIRI plus apatinib or FOLFIRI plus bevacizumab) in the 2nd line setting. To identify specific biomarkers at the genetic and proteomic levels between two arms is the primary end point.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Apatinib Mesylate Tablets

Apatinib combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC

DRUG

Bevacizumab Injection

Bevacizumab combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC

Sponsors & Collaborators

  • Shenzhen People's Hospital

    lead OTHER

Principal Investigators

  • Wan He, PhD,MD · Shenzhen People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-22
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03743428 on ClinicalTrials.gov