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Status unknownNCT03788174Updated May 10, 2019

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

A Phase 2 interventional study of Apatinib and POF in Gastric Adenocarcinoma, sponsored by Fujian Cancer Hospital. Status unknown at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by Fujian Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
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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.

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Conditions studied

  • Gastric Adenocarcinoma

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03

In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 26 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

Fujian Cancer Hospital is the lead sponsor of 155 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients with advanced unresectable, histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction.
  • Previous first-treatment with chemotherapy or radiation therapy failed. Ability to take medications orally. With measurable lesions. Patients must have a performance status of 0-1 on the Eastern 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 total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (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 of congestive heart failure.
  • Without bleeding and thrombosis disease. With normal coagulation function: activated partial thromboplastin time (APTT), prothrombin time (PT) and INR, each ≤ 1.5 x ULN.
  • Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 8 weeks after last dose of study drug With written informed consent signed voluntarily by patients themselves or their supervisors witted by doctors.
  • With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion criteria

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, or nonmetastatic 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, 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 or coagulopathy.
  • History of a stroke or CVA within 6 months. Clinically significant peripheral vascular disease. Inability to comply with study and/or follow-up procedures. Patients with any other medical condition or reason, in that investigator's opinion, makes the patient unstable to participate in a clinical trial.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Apatinib plus POF

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

    Drug: Apatinib · Drug: POF

Interventions

  • DrugApatinib

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

  • DrugPOF

    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.

06

What researchers measure

Primary outcomes

  1. Objective response rate

    According to RECIST 1.1

    Time frame: From enrollment to 3 months after treatment

Secondary outcomes

  1. Progression-free survival

    The length of time from enrollment until the time of progression of disease

    Time frame: From enrollment to progression of disease. Estimated about 12 months.

  2. Overall survival

    The length of time from enrollment until the time of death

    Time frame: From enrollment to death of patients. Estimated about 18 months

  3. Toxicity According to NCI CTCAE 4.03 criteria

    According to NCI CTCAE 4.03 criteria

    Time frame: From enrollment to 3 months after treatment

07

Study locations

2 of 2 sites recruiting
  • Rongbo Lin
    Fuzhou, Fujian 350014, China
    Recruiting
  • Rongbo Lin
    Fuzhou, 350014, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03788174
Lead sponsor
Fujian Cancer Hospital
Responsible party
Sponsor
First posted
Dec 27, 2018
Start date
Feb 1, 2019
Primary completion
Dec 2019 (estimated)
Completion
Dec 2020 (estimated)
Last update
May 10, 2019

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.

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