Clinical trial NCT04121039: Study of the Apatinib Combine With POF Versus POF in Gastric Cancer
Official title: A Randomized,Parallel Controlled,Multicentre,Phase II Study of Apatinib Plus POF (Paclitaxel Plus Oxaliplatin Plus 5-fluorouracil Plus Leucovorin) Versus POF in Patients With Advanced/Metastatic Bastric Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Adenocarcinoma
Advanced Cancer
Lead sponsor: Fujian Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2019-10-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized, parallel control, multicenter,phase II study, comparing the efficacy and safety of apatinib plus POF(paclitaxel plus oxaliplatin plus 5-fluorouracil plus leucovorin) versus POF, in the first-line treatment for patients with advanced/metastatic gastric cancer.

Detailed 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) 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) Rate at 6-month
timeFrame: Up to approximately 6 months
Secondary outcomes:
measure: Objective Overall Response Rate (ORR)
timeFrame: From randomization to 24 month
measure: Overall Survival (OS)
timeFrame: From randomization to 24 month
measure: Progression-Free Survival (PFS)
timeFrame: From randomization to 24 month
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Rongbo Lin
state: Fujian
Study officials:
References: