Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study)

Phase I/II trial of combined chemotherapy of Nab-paclitaxel, S-1, and Oxaliplatin for gastric cancer patients with peritoneal metastasis (NSOX study) - NSOX study

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000030909

Enrollment

Registered

2018-01-20

Start date

2018-01-12

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

nab-paclitaxel,S-1, oxaliplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma of gastric cancer and positive peritoneal dissemination by staging laparoscopy 2. HER2 negative (or untested) 3. No non-curable factors except peritoneal dissemination 4. No prior chemotherapy or radiation therapy (in case of previous adjuvant therapy, interval from end of chemotherapy and relapse must be >6 months for S-1 therapy) 5. age 20<= years, 75>= years 6. ECOG PS 0 or 1 7. Ingestible 8. Hematological status: neutrophils (ANC)>=1,500 /mm3; platelets >=100,000 /mm3; haemoglobin >=8g/dL, Adequate renal function: serum creatinine level <=1.2mg/dl,Ccr >=60mL/min, Adequate liver function: serum bilirubin <=2.0 xupper normal limit (ULN), AST/ALT<=100 U/L 9. Expected life span >=3 months 10.Signed and dated informed consent

Exclusion criteria

Exclusion criteria: 1. History of hypersensitivity to nab-paclitaxel, S-1, oxaliplatin 2. Contraindication to nab-paclitaxel, S-1, oxaliplatin 3. Infectious disease 4. HBs-antigen positive 5. Severe complication 6. Neuropathy with symptoms 7. Brain metastasis with clinical symptoms 8. Watery diarrhea. 9. Active double cancer 10. Persons to be pregnant or to make pregnant 11. Any subject judged by the investigator to be unfit for any reason to participate in the study

Design outcomes

Primary

Measure	Time frame
Phase I: DLT Phase II: The rate of negative conversion in P1	—

Secondary

Measure	Time frame
Phase 1: MTD, RD, adverse events, pharmacokinetics Phase 2: completion rate of treatment, response rate, curative resection rate, postoperative complication, pathological response rate, progression free survival, duration of disease control, recurrent free survival after gastrectomy, overall survival, time to treatment failure	—

Countries

Japan

Contacts

Public ContactMasaki Nakamura

Wakayama Medical University, School of Medicine Second Department of Surgery

twins@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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