A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer

A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer - A phase II study of S-1,cisplatin and lentinan in first-line treatment of unresectable or recurrent gastric cancer

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000001913

Enrollment

Registered

2009-05-01

Start date

2008-10-01

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

unresectable or recurrent gastric cancer

Interventions

Chemotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with unresected or recurrent gastric cancer that pathorogically confiemed 2)No privious treatment (patients who underwent aduvant chemotherapy except S-1 or cisplatin before more than 30 days can be registerd.) 3)Performance Status:0 or 1 4)Age between 20 and 75 years old when an informed concent was taken. 5)Patients who are expected to survive for more than three months 6)Patients who can eat oraly 7)Written informed consent to participate in this study. 8)Biology and biochemistry data are fit for the following criteria within 14 days before registration. a) WBC; 3,500/mL b) PLT; 100,000/mL c) Hb; 8.0 g/dL d) AST, ALT; ULN x 2.0 e) T-Bil; ULN x 2.0 f) CRE; ULN or CCR; 50ml/min

Exclusion criteria

Exclusion criteria: 1)Patients who have a contraindication of S-1 or cisplatin 2)Patients who had infection or inflammatory disease 3)Patients who have or had severe heart disease 4)Patients who have severe commplication, such as ileus,intestinal pneumonia,fibroid lung, uncontrolled diabetes mellitus,renal failure, liver cirrhosis and so on 5)massive asites 6)multiple bone metastases 7)brain metastases 8)fresh gastrointestinal bleeding 9)diarrhea 10)mental disorder 11)synchronous multicancer 12)Patients pregnant or in lactation, or wish to become pregnant during this study. Male patients who intend to make someone pregnant during this study 13)Men who want a baby 14)Patient who is judged to be inappropriate for this study by the principal investigator or the doctors in charge

Design outcomes

Primary

Measure	Time frame
1 year survival rate	—

Secondary

Measure	Time frame
Overall survival, response rate, progression free survival, time to treatment failure, relation between survival time and G/L ratio	—

Countries

Japan

Contacts

Public ContactOsamu Hachiya

Yamagata University Faculty of Medicine Department of Gastroenterological, General, Breast and Thyroid Surgery

Outcome results

None listed

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