Phase I/II trial of combined chemotherapy of S-1, Nab-paclitaxel and Oxaliplatin administered bi-weekly for patients with advanced gastric cancer(HGCSG1404: SNOW study)

Phase I/II trial of combined chemotherapy of S-1, Nab-paclitaxel and Oxaliplatin administered bi-weekly for patients with advanced gastric cancer(HGCSG1404: SNOW study) - HGCSG1404: SNOW study

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016788

Enrollment

Registered

2015-03-16

Start date

2015-11-13

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

advanced / reccurent gastric cancer

Interventions

S-1, nab-paclitaxel, oxaliplatin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma of the advanced or recurrent gastric cancer 2. HER2 negative (or untested) 3. With measurable disease (RECIST v1.1) 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 6. ECOG PS 0 or 1 7. Ingestible 8. Hematological status: neutrophils (ANC)>=1.5x109/L; platelets >=100x109/L; haemoglobin >=8g/dL, Adequate renal function: serum creatinine level >=1.2mg/dl,Ccr >=60mL/min, Adequate liver function: serum bilirubin <=2.0 x upper 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, oxaliplatin, S-1 2. Contraindication to nab-paclitaxel, oxaliplatin, S-1 3. Infectious disease 4. HBs-antigen positive 5. Severe complication 6. Neuropathy with symptoms 7. Brain metastasis with clinical symptoms 8. Watery diarea. 9. Active double cancer 10. Persons to be pregnant or to make pregnant

Design outcomes

Primary

Measure	Time frame
phase 1: MTD, RD	—

Secondary

Measure	Time frame
phase 1: response rate, adverse events, pharmacokinetics phase 2: safety, progression free survival, duration of disease control, overall survival, time to treatment failure, expression of SPARC	—

Countries

Japan

Contacts

Public ContactYasuyuki Kawamoto

Hokkaido University Hospital Department of Gastoenterology and Hepatology

y-kawamoto0716@hotmail.co.jp011-706-5657

Outcome results

None listed

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