Study of the Combination of Apatinib and POF
- Registration Number
- NCT03707639
- Lead Sponsor
- Fujian Cancer Hospital
- Brief Summary
In previous studies, we found that POF (A combination of oxaliplatin, fluorouracil and Paclitaxel) regimen appears to be of good efficacy and is well tolerated in patients with advanced gastric cancer. Apatinib is an orally antiangiogenic agent. It was approved and launched in China in 2014 as a 3rd-line treatment for patients with advanced gastric cancer. Therefore, investigators conducted the dose escalation phase I study to explore the safety of combination of apatinib and POF as first-line treatment for advanced gastric cancer. Now we are going to start a phase 2 trial with apatinib 500mg + POF as first-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
No previous treatment with chemotherapy or radiation therapy. Ability to take medications orally. With measurable lesions. Patients must have a performance status of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.
Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without blood transfusion during 14 days); a leucopenia count of ≥4.0×109/L; a platelet count of ≥100×109/L; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml/min (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.
Life expectancy ≥3 months. With normal electrocardiogram results and no history of congestive heart failure.
Without bleeding and thrombosis disease. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
With good compliance and agree to accept follow-up of disease progression and adverse events.
Patients with a history of another neoplastic disease within the past three years, excluding basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer.
Patients with brain or central nervous system metastases, including leptomeningeal disease.
Pregnant (positive pregnancy test) or breast feeding. Serious, non-healing wound, ulcer, or bone fracture. Significant cardiac disease as defined as: unstable angina, New York Heart Association (NYHA) grade II or greater, congestive heart failure, history of myocardial infarction within 6 months Evidence of bleeding diathesis or coagulopathy.
History of a stroke or CVA within 6 months. Clinically significant peripheral vascular disease. Inability to comply with study and/or follow-up procedures. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental: Apatinib plus POF POF Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients. Experimental: Apatinib plus POF Apatinib Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.
- Primary Outcome Measures
Name Time Method Objective response rate From enrollment to 3 months after treatment According to RECIST 1.1
- Secondary Outcome Measures
Name Time Method Overall survival 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 From enrollment to 3 months after treatment According to NCI CTCAE 4.03 criteria
Progression-free survival From enrollment to progression of disease. Estimated about 12 months. The length of time from enrollment until the time of progression of disease
Trial Locations
- Locations (1)
Rongbo Lin
🇨🇳Fuzhou, Fujian, China