S1+ Paclitaxel (IV&IP) + Bevacizumab (IP) Versus S1+Oxaliplatin as First-line Treatment in Gastric Cancer With Malignant Ascites

Sponsor
China Medical University, China
Study ID
NCT03990103
Phase
PHASE2
Status
Unknown

Conditions

  • Metastatic Gastric Adenocarcinoma

Eligibility Criteria

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

Interventions

  • S1 — DRUG
    80-120 mg/day, PO, D1-14, every 21 days
  • Paclitaxel — DRUG
    20 mg/m2/day, IP, D1-3; 50 mg/m2, IV, D1; 70 mg/m2, IV, D8; every 21 days
  • Bevacizumab — DRUG
    200 mg, IP, D1, every 21 days
  • Oxaliplatin — DRUG
    130 mg/m2, IV, D1, every 21 days

Study Details

The purpose of this study is to compare the efficacy of S1 plus paclitaxel (intravenous injection \& intraperitoneal injection) plus bevacizumab (intraperitoneal injection) vs. S1 plus oxaliplatin intravenous injection as first-line treatment in gastric or gastroesophageal junctional adenocarcinoma with malignant ascites.

Key Dates

First listed
Jun 18, 2019
Start date
Nov 1, 2017
Status verified
Jun 2019
Primary completion
Apr 30, 2021
Completion
Apr 30, 2022

Study Design

Enrollment
66 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental arm
    S1+Paclitaxel (IV\&IP)+Bevacizumab (IP)
  • Active Comparator: Control arm
    S1+Oxaliplatin (IV)

Primary Outcome Measure

Ascites response rate at 6 weeks [ Time Frame: 6 weeks ]

Central Contacts

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