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

NCT ID: NCT04121039

Last Updated: 2019-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-31
• Study Completion Date: 2023-12-31

Brief Summary

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.

Detailed Description

This is a randomized, two-arm, open-label, multicenter phase II trial. Our primary purpose is to compare that PFS rate at 6-month of patients with apatinib plus POF and POF for advanced/metastatic gastric cancer.

Eligible patients will randomized to a ratio of 1:1 to apatinib+POF (experimental group) or POF (control group). Stratification factors were 1) gender (male;female);2) previous surgical history (yes;no);3) metastatic sites (measurable; Immeasurable).

In treatment period, patients will be administrated POF, with or without apatinib, every 14 days for 1 cycle, total 9-12 cycles.After the above treatment finished,parients will received with S-1,with or without apatinib,every 21days for 1 cycle,until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Conditions

Gastric Adenocarcinoma; Advanced Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Apatinib

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

Apatinib

Intervention Type: DRUG

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

POF

Intervention Type: 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.

Interventions

Apatinib

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Study drug

Eligibility Criteria

Inclusion Criteria

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

No previous treatment with chemotherapy or radiation therapy. 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

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fujian Cancer Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Rongbo Lin

Fuzhou, Fujian, China

Countries

China

Central Contacts

Rongbo Lin

Role: CONTACT

rongbo_lin@163.com

13705919382 ext. 13705919382

Other Identifiers

FNF016

Identifier Type: -

Identifier Source: org_study_id