Phase I study of weekly intraperitoneal paclitaxel combined with oxaliplatin plus S-1 for advanced gastric cancer with peritoneal metastasis

Phase I study of weekly intraperitoneal paclitaxel combined with oxaliplatin plus S-1 for advanced gastric cancer with peritoneal metastasis - Phase I study of IP PTX plus SOX

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004978

Enrollment

Registered

2011-01-29

Start date

2010-11-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

gastric cancer with peritoneal metastasis

Interventions

PTX is administered intraperitoneally with an initial dose of 20 mg/m2, stepped up to 30 or 40 mg/m2. S-1 is administered at a fixed dose of 80 mg/m2/day for 14 consecutive days, followed by 7 days re

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis and/or cancer cells on peritoneal cytology; age more than 20 years; Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow function (leukocyte count 3,000-12,000/mm3, hemoglobin >8.0 g/dl, platelet count >100,000/mm3); adequate liver function (total serum bilirubin <1.5 mg/dl, serum transaminases <100/UI); adequate renal function (serum creatinine within the upper limit of normal); and an expected survival period of more than 3 months.

Exclusion criteria

Exclusion criteria: Metastasis to distant organ sites (such as the liver, lungs or bone), other active concomitant malignancies, or other severe medical conditions.

Design outcomes

Primary

Measure	Time frame
safety	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026