Apatinib Combined With POF for Second-line Treatment of Gastric Adenocarcinoma

Last updated: May 8, 2019
Sponsor: Fujian Cancer Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Adenocarcinoma

Gastric Ulcers

Stomach Cancer

Treatment

N/A

Clinical Study ID

NCT03788174
FNF013
  • Ages 18-70
  • All Genders

Study Summary

In previous studies,the investigators 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 the investigators are going to start a phase 2 trial with apatinib 500mg

  • POF as second-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with advanced unresectable, histologically confirmed adenocarcinoma of thegastric or gastroesophageal junction.

  • Previous first-treatment with chemotherapy or radiation therapy failed. Ability totake medications orally. With measurable lesions. Patients must have a performancestatus of 0-1 on the Eastern Cooperative Oncology Group (ECOG) scale.

  • Without serious system dysfunction and could tolerate chemotherapy. With normalmarrow, liver and renal function: a hemoglobin (HGB) of ≥100g/L (without bloodtransfusion 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); acreatinine (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 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 weeksafter discontinuing study drug. Male subjects must agree to use contraceptive measuresduring the study and 8 weeks after last dose of study drug With written informedconsent signed voluntarily by patients themselves or their supervisors witted bydoctors.

  • 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 leptomeningealdisease.

  • 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 orcoagulopathy.

  • 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: 26
Study Start date:
February 01, 2019
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Rongbo Lin

    Fuzhou, 350014
    China

    Active - Recruiting

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