Phase II study of intraperitoneal paclitaxel combined with S-1 plus oxaliplatin as second-line chemotherapy for advanced gastric cancer with peritoneal metastasis

Phase II study of intraperitoneal paclitaxel combined with S-1 plus oxaliplatin as second-line chemotherapy for advanced gastric cancer with peritoneal metastasis - Phase II study of SOX+IP PTX (second-line)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000012836

Enrollment

Registered

2014-04-01

Start date

2014-04-01

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 at 40 mg/m2 on days 1 and 8. S-1 is administered at 80 mg/m2/day for 14 consecutive days, followed by 7 days rest. Oxaliplatin is administered at 100 mg/m2 on

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven unresectable or recurrent gastric adenocarcinoma; peritoneal metastasis; 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
1-year overall survival	—

Secondary

Measure	Time frame
response rate negative conversion rate on peritoneal cytology safety	—

Countries

Japan

Contacts

Public ContactHironori Ishigami

The University of Tokyo Department of Chemotherapy

ishigami-tky@umin.net03-3815-5411

Outcome results

None listed

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