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

Sponsor
Fujian Cancer Hospital
Study ID
NCT04121039
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Cancer
  • Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 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

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.

Key Dates

Start date
Dec 31, 2019
Status verified
Oct 2019
Primary completion
Dec 31, 2021
Completion
Dec 31, 2023

Study Design

Enrollment
116 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apatinib plus POF
    Participants will receive apatinib in combination with POF,total 9-12 cycles.Then receive apatinib plus S-1 until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
  • Active Comparator: POF
    Participants will receive POF,total 9-12 cycles.Then receive S-1 until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Primary Outcome Measure

Progression-Free Survival (PFS) Rate at 6-month [ Time Frame: Up to approximately 6 months ]

Central Contacts

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