Study of the Apatinib Combine With POF Versus POF in Gastric Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Advanced Cancer
- Gastric Adenocarcinoma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
This is a randomized, two-arm, open-label, multicenter phase II trial. Our primary purpose is to compare that PFS rate at 6-month of patients with apatinib plus POF and POF for advanced/metastatic gastric cancer. Eligible patients will randomized to a ratio of 1:1 to apatinib+POF (experimental group...
This is a randomized, two-arm, open-label, multicenter phase II trial. Our primary purpose is to compare that PFS rate at 6-month of patients with apatinib plus POF and POF for advanced/metastatic gastric cancer. Eligible patients will randomized to a ratio of 1:1 to apatinib+POF (experimental group) or POF (control group). Stratification factors were 1) gender (male;female);2) previous surgical history (yes;no);3) metastatic sites (measurable; Immeasurable). In treatment period, patients will be administrated POF, with or without apatinib, every 14 days for 1 cycle, total 9-12 cycles.After the above treatment finished,parients will received with S-1,with or without apatinib,every 21days for 1 cycle,until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination. The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.
Tracking Information
- NCT #
- NCT04121039
- Collaborators
- Not Provided
- Investigators
- Not Provided