Study of the Combination of Apatinib and POF
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|ClinicalTrials.gov Identifier: NCT03707639|
Recruitment Status : Not yet recruiting
First Posted : October 16, 2018
Last Update Posted : October 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: Apatinib Drug: POF||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of the Combination of Apatinib and POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin)|
|Estimated Study Start Date :||November 2018|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||November 2020|
Experimental: Experimental: Apatinib plus POF
Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.
Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
- Objective response rate [ Time Frame: From enrollment to 3 months after treatment ]According to RECIST 1.1
- Progression-free survival [ Time Frame: From enrollment to progression of disease. Estimated about 12 months. ]The length of time from enrollment until the time of progression of disease
- Overall survival [ Time Frame: From enrollment to death of patients. Estimated about 18 months ]The length of time from enrollment until the time of death
- Toxicity According to NCI CTCAE 4.03 criteria [ Time Frame: From enrollment to 3 months after treatment ]According to NCI CTCAE 4.03 criteria
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): NCT03707639
|Contact: Rongbo Lin||13705919382 ext email@example.com|
|Fuzhou, Fujian, China, 350014|
|Study Chair:||Rongbo Lin||Fujian Cancer Hospital|