Randomized phase III study of TS-1 alone versus TS-1 plus Lentinan(LNT) in advanced or recurrent gastric cancer (AGC)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000574

Enrollment

300

Registered

2007-01-20

Start date

2007-02-01

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

Advanced or recurrent gastric cancer (AGC)

Interventions

TS-1 alone : TS-1 is administered orally at the dose of 80mg/m2/day for 28 days, followed by 14 days rest. TS-1+ Lentinan : TS-1 is administered orally at the dose of 80mg/m2/day for 28 days, followed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Histologically demonstrated adenocarcinoma of advanced or recurrent gastric carcinoma 2) If measurable lesions exist, these have to be evaluated within 28 days before registration 3) No prior therapy 4) Sufficient organ functions 5) Performance Status (ECOG scale) : 0-2 6) Expected survival over 3 months 7) Oral intake is possible 8) Written informed consent

Exclusion criteria

Exclusion criteria: 1) Limitation of use of TS-1 or Lentinan 2) Infection and inflammation 3) Serious heart disease 4) Serious coexisting illness 5) A large amount of pleural effusion or peritoneal fluid 6) Broad bone metastasis 7) Brain metastasis 8) Fresh bleeding from digestive organs 9) Diarrhea 10) Severe mental disorders 11) Active synchronous malignancy 12) Pregnant or nursing 13) Not suitable for participating in this study for any other reason

Design outcomes

Primary

Measure	Time frame
overall survival	—

Secondary

Measure	Time frame
TTF, adverse events, QOL, tumor response	—

Countries

Japan

Outcome results

None listed

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