Apatinib Versus Bevacizumab in Second-line Therapy for Colorectal Cancer(ABST-C)
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|ClinicalTrials.gov Identifier: NCT03271255|
Recruitment Status : Recruiting
First Posted : September 5, 2017
Last Update Posted : January 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms||Drug: Apatinib Mesylate Tablets Drug: Bevacizumab Injection||Phase 2|
Firstly, screen eligible mCRC patients for enrolment. Our CRC clinical nurse specialists will document medical history of patients including diagnoses, first-line chemotherapy (mFOLFOX6 or CAPOX),bevacizumab dosage,toxicities,PFS on previous therapy.In the meantime,chest-abdonimal-pelvic CT and blood tests are to be examined to assess base-line measurable lesions and guarantee adequate organ function prior to enrolment.If all the values meet the criteria for enrolment, consent will be signed.
Secondly, randomise patients into two arms: Arm A-apatinib plus FOLFIRI regimen and arm B-bevacizumab plus FOLFIRI regimen.A software which is alike the procedure of coin flipping is used to randomise eligible patients.According to the selected regimen in specific arm,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 CEA and CA199) before each cycle will be recorded and the consultant oncologist, who is responsible for individual participants, will decide whether to continue next cycle chemotherapy with apatinib or bevacizumab based on the assigned arm.Radiological assessment consisting of chest-abdonimal-pelvic CT will be performed every 2 months.Notably,the monitor will check with physicians and nurse specialists for the accuracy and completeness of all data.
Thirdly, follow up participants and analyse primary end point (PFS) and secondary end points (OS,ORR and DCR).The causes of confirmed missing data in the trial should be recorded in detail to determine the mechanism of missing data and choose the suitable missing data handling methods.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Head-to-head comparison of apatinib versus bevacizumab plus sencond-line chemotherapy regimen FOLFIRI for treatment of metastatic colorectal cancer|
|Masking:||None (Open Label)|
|Official Title:||Apatinib Versus Bevacizumab in Combination With Second-line FOLFIRI in Patients With Metastatic Colorectal Cancer That Progressed During or After First-line Bevacizumab Plus an Oxaliplatin-based Regimen: A Randomised Phase 2 Trial|
|Actual Study Start Date :||May 23, 2018|
|Estimated Primary Completion Date :||September 30, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Arm Apatinib
Apatinib Mesylate Tablets 500 mg 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 combination with FOLFIRI regimen as the second-line chemotherapy for mCRC
Other Name: YN968D1
Active Comparator: Arm Bevacizumab
Bevacizumab Injection 5 mg/kg IV over 30 minutes,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 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion; Repeat every 2 weeks.
Drug: Bevacizumab Injection
Bevacizumab combination with FOLFIRI regimen as the second-line chemotherapy for mCRC
Other Name: Avastin
- Progression-free Survival (PFS) Time [ 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.
- Percentage of Participants Achieving an Objective Response (Objective Response Rate) [ Time Frame: The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission. ]The objective response rate is equal to the proportion of participants achieving a best overall response of partial response or complete response (PR + CR). Response was defined using RECIST, v. 1.1 criteria. CR was defined as the disappearance of all target and non-target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and normalization of tumor marker level of non-target lesions; PR was defined as having at least a 30% decrease in sum of longest diameter of target lesions taking as reference the baseline sum diameter.
- Percentage of Participants Achieving a Stable Disease (SD) or a confirmed CR or PR (Disease Control Rate) [ Time Frame: The follow-up period ranges from the first patient recruited to the last patient within 3 months after admission. ]Participants achieved disease control if they had a best overall response of CR, PR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all non-target lesions, and the normalization of tumor marker levels (if tumor markers were initially above the ULN); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03271255
|Contact: Ruilian Xu, MDfirstname.lastname@example.org|
|Contact: Wan He, MD,PhDemail@example.com|
|China, Guang Dong|
|Shenzhen People's Hospital||Recruiting|
|Shenzhen, Guang Dong, China|
|Contact: Ruilian Xu, MD +8613923889123 firstname.lastname@example.org|
|Contact: Wan He, MD,PhD +8618823719462 email@example.com|
|Principal Investigator:||Ruilian Xu, MD||Shen Zhen People's Hospital|