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Study of the Combination of Apatinib and POF

NCT03707639 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2018-10-16

No results posted yet for this study

Summary

In previous studies, we 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 we are going to start a phase 2 trial with apatinib 500mg + POF as first-line therapy to investigate the efficacy and safety in the patients with advanced gastric cancer.

Conditions

  • Gastric Adenocarcinoma

Interventions

DRUG

Apatinib

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

DRUG

POF

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.

Sponsors & Collaborators

  • Fujian Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Rongbo Lin · Fujian Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-30
Primary Completion
2019-10-31
Completion
2020-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03707639 on ClinicalTrials.gov