Biomarkers for Apatinib and Bevacizumab in Second-line Therapy for Colorectal Cancer(BABST-C) (BABST-C)
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|ClinicalTrials.gov Identifier: NCT03743428|
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms||Drug: Apatinib Mesylate Tablets Drug: Bevacizumab Injection||Not Applicable|
Based on inclusion and exclusion criteria, eligible mCRC patients are enrolled. the chest-abdonimal-pelvic CT with brain MRI and blood tests are examined to assess base-line measurable lesions and guarantee adequate organ function prior to enrollment. The written consents are signed before enrollment. Randomise patients into two arms: Arm A-apatinib plus FOLFIRI regimen and arm B-bevacizumab plus FOLFIRI regimen. Patients will be given full-dose drugs or reduced-dose drugs if serious toxicities ( CTCAE v4.0 criteria grade 3/4) are complained since previous cycle of treatment.
Symptoms and blood test results (including carcinoembryonic antigen（CEA）and CA199) before each cycle will be recorded. Radiological assessment consisting of chest-abdonimal-pelvic CT together with brain MRI will be performed every 3 months.
Collect biopsy specimens and peripheral blood from mCRC patients every 3 months since randomisation. Identify differential biomarkers between apatinib and bevacizumab and define these biomarkers' prognostic and predictive significances.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Head-to-head comparison of apatinib versus bevacizumab plus second-line chemotherapy regimen FOLFIRI for treatment of metastatic colorectal cancer|
|Masking:||None (Open Label)|
|Masking Description:||No masking|
|Primary Purpose:||Basic Science|
|Official Title:||The Biomarkers Identification for Apatinib and Bevacizumab in the Second-line Therapy for Colorectal Cancer: A Randomised Controlled Trial|
|Estimated Study Start Date :||October 22, 2019|
|Estimated Primary Completion Date :||November 1, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Apatinib Mesylate Tablets 250mg po qd Irinotecan 180 mg/m2 IV over 30-90 minutes,day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion,day 1 5-FU 400 mg/m2 IV bolus day 1,then 1200 mg/m2/d x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks.
Drug: Apatinib Mesylate Tablets
Apatinib combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC
Other Name: YN968D1
Active Comparator: Bevacizumab-FOLFIRI
Bevacizumab Injection 5mg/kg IV,day 1 Irinotecan 180 mg/m2 IV over 30-90 minutes,day 1 Leucovorin 400 mg/m2 IV infusion to match duration of irinotecan infusion,day 1 5-FU 400 mg/m2 IV bolus day 1,then 1200 mg/m2/d x 2days (total 2400 mg/m2 over 46-48 hours) continuous infusion Repeat every 2 weeks.
Drug: Bevacizumab Injection
Bevacizumab combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC
Other Name: Avastin
- Identify biomarkers specific to apatinib or bevacizumab by transcriptome analysis [ Time Frame: 4 years ]Identify differentially expressed genes specific to apatinib or bevacizumab by the next‐generation RNA‐seq technology .
- Identify biomarkers specific to apatinib or bevacizumab by proteomic analysis [ Time Frame: 4 years ]Identify proteomic molecules specific to apatinib or bevacizumab by the photoreactive crosslinking, pull-down, affinity purification and mass spectrometry (AP-MS) analyses
- Progression-free Survival (PFS) [ Time Frame: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission, up to 2 years ]PFS was defined as the time from the date of randomization until the date of objectively determined progressive disease (PD) [according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v). 1.1] or death due to any cause, whichever was first. PD is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeters (mm). Participants who died without a reported prior progression were considered to have progressed on the day of their death. Participants who did not progress or were lost to follow-up were censored at the day of their last radiographic tumor assessment.
- Overall Survival (OS) [ Time Frame: The follow-up period ranges from the first patient recruited to the last patient within 6 months after admission,up to 2 years ]OS was defined as the time in months from the date of randomization to the date of death from any cause. For participants not known to have died as of the cut-off date, OS was censored at the last known date alive.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03743428
|Contact: Wan He, PhD,MDemail@example.com|
|Contact: Ruilian Xu, MDfirstname.lastname@example.org|
|China, Guang Dong|
|Shenzhen People's Hospital||Recruiting|
|Shenzhen, Guang Dong, China|
|Contact: Wan He, PhD,MD|
|Principal Investigator:||Wan He, PhD,MD||Shenzhen People's Hospital|