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

Sponsor
Fujian Cancer Hospital
Study ID
NCT03788174
Phase
PHASE2
Status
Unknown

Conditions

  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Apatinib — DRUG
    Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
  • POF — DRUG
    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.

Study Details

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.

Key Dates

Start date
Feb 1, 2019
Status verified
Dec 2018
Primary completion
Dec 31, 2019
Completion
Dec 31, 2020

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib plus POF
    Apatinib (500 mg qd p.o.) plus POF until disease progression or intolerable toxicity or refused by the patients.

Primary Outcome Measure

Objective response rate [ Time Frame: From enrollment to 3 months after treatment ]

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