Study of the Apatinib Combine With POF Versus POF in Gastric Cancer

Last updated: October 8, 2019
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gastric Cancer

Adenocarcinoma

Gastric Ulcers

Treatment

N/A

Clinical Study ID

NCT04121039
FNF016
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with advanced unresectable, histologically confirmed adenocarcinoma of thegastric or gastroesophageal junction. No previous treatment with chemotherapy or radiation therapy. Ability to take medicationsorally. With measurable lesions. Patients must have a performance status of 0-1 on theEastern 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 totalbilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; acreatinine 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 ofcongestive heart failure. Without bleeding and thrombosis disease. With normal coagulation function: activatedpartial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN. Female subjects of child-bearing potential must agree to use contraceptive measuresstarting 1 week before the administration of the first dose of apatinib until 8 weeks afterdiscontinuing study drug. Male subjects must agree to use contraceptive measures during thestudy and 8 weeks after last dose of study drug With written informed consent signedvoluntarily by patients themselves or their supervisors witted by doctors. With good compliance and agree to accept follow-up of disease progression and adverseevents.

Exclusion

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, ornonmetastatic 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, orbone fracture. Significant cardiac disease as defined as: unstable angina, New York HeartAssociation (NYHA) grade II or greater, congestive heart failure, history of myocardialinfarction within 6 months Evidence of bleeding diathesis or coagulopathy. History of a stroke or CVA within 6 months. Clinically significant peripheral vasculardisease. Inability to comply with study and/or follow-up procedures. Patients with anyother medical condition or reason, in that investigator's opinion, makes the patientunstable to participate in a clinical trial.

Study Design

Total Participants: 116
Study Start date:
December 01, 2019
Estimated Completion Date:
December 31, 2023

Study 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.

Connect with a study center

  • Rongbo Lin

    Fuzhou, Fujian 350014
    China

    Site Not Available

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