A Study of Intraperitoneal Paclitaxel in Combination With SOX Compared With SOX Alone in Gastric Cancer With Malignant Ascites

A Randomized Study of the Effect of First-line Intraperitoneal Paclitaxel in Combination With SOX Versus SOX Alone in Gastric Cancer Patients With Malignant Ascites

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03475615

Enrollment

215

Registered

2018-03-23

Start date

2018-03-16

Completion date

2020-12-31

Last updated

2018-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Stomach Neoplasms

Brief summary

This study is designed to compare the efficacy of intraperitoneal paclitaxel in combination with SOX, with SOX alone in the first-line treatment of gastric cancer with malignant ascites

Interventions

DRUGOxaliplatin

130mg/m2, d1, q3w

DRUGPaclitaxel

40mg/m2 ip，d1、8 ,q3w

DRUGS-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)

40mg/m2 Bid po，d1-14,q3w

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* had a histologically proven adenocarcinoma of the gastroesophageal junction, or stomach that was locally advanced (inoperable) or metastatic * malignant ascites(over pelvic cavity in CT scan and confirmed by cytology) * an Eastern Cooperative Oncology Group performance status of 0 to 2 * adequate renal, hepatic, and hematologic function

Exclusion criteria

* previous chemotherapy or radiotherapy (unless in the adjuvant setting) * uncontrolled cardiac disease, or other clinically significant, uncontrolled * coexisting illness or previous or concurrent cancer * HER2 positive and willing to use trastuzumab

Design outcomes

Primary

Measure	Time frame	Description
overall survival	10 months	the internal between the date of enrollment and the date of death or last follow-up.

Countries

China

Contacts

Primary ContactZhu Xiaodong, MD

xddr001@163.com86-21-64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026