A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer.

A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer. - A feasibility study of Krestin (PSK) plus TS-1 combination therapy for resectable gastric cancer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000004534

Enrollment

Registered

2010-11-10

Start date

2011-01-01

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

Interventions

TS-1 plus PSK therapy PSK is given 3 g/day daily in 1 to 3 divided doses a day for 1 week within 8 weeks after surgery. Then, TS-1 is given in two divided doses a day (after breakfast and dinner) fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In this study, we use Japanese Classification of Gastric cancer (The 14th Edition). 1. Histologically proven gastric cancer. 2. Stage IB, IIA, IIB, IIIA, IIIB except for T2, N0 patients. 3. R0. 4. Age between 20 and 80 years at the time of consent acquisition. 5. Patients can take orally within 8 weeks after surgery (day of surgery as 0 day). 6. No preoperative treatment, such as radiotherapy, chemotherapy and hormone therapy. 7. No severe disorder of renal function, hepatic function, bone-marrow function. 8. Performance status of 0-2. 9. No severe complication, such as myelosuppression, diarrhea, infection. 10. Written informed consent.

Exclusion criteria

Exclusion criteria: 1. Fresh gastrointestinal bleeding. 2. Active double cancer. 3. Administration contraindication of TS-1. 4. Continuous use of flucytosine, phenytoin or warfarin potassium. 5. History of severe drug allergy (over grade 3). 6. Severe complications such as paralytic ileus, bowel obstruction, interstitial pneumonitis or pulmonary fibrosis, uncontrolled diabetic mellitus, heart failure, renal failure and hepatic failure etc. 7. Severe watery diarrhea. 8. Female who are pregnant, nursing, suspected of being pregnant or hope to become pregnant during the study period. 9. No birth-control. 10. HIV positive. 11. Patients judged inappropriate for the study by their physicians.

Design outcomes

Primary

Measure	Time frame
Rate of treatment accomplishment	—

Secondary

Measure	Time frame
1.Relative performance (RP:%) 2.Adverse event and its frequency 3.5 year recurrence-free survival time and 5 year overall survival time	—

Countries

Japan

Outcome results

None listed

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