Randomized controlled trial to evaluate the prediction of the immunotherapy response based on HLA-type.

Randomized controlled trial to evaluate the prediction of the immunotherapy response based on HLA-type. - Randomized controlled trial of HLA type-oriented therapy (JSCT trial).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037483

Enrollment

600

Registered

2019-07-29

Start date

1992-08-01

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 and colorectal cancer

Interventions

R0: Gastrectomy alone Chemotherapy: F/MF PSK group: F/MF and PSK R(+) Chemotherapy: MF/CF PSK group: MF/CF and PSK PSK was administered orally from 14 days after gastrectomy at a dose

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Primary advanced gastric and colorectal cancer patients who gave informed consent and received the examination of HLA. MMC injection (dose and frequency) and the selection of F drugs was depended on an attending doctor

Exclusion criteria

Exclusion criteria: 1. Double cancer. 2. Mucosal and no lymph node metastasis. 3. Prior cytotoxic or radiation therapy. 4. Abnormal bone marrow, hepatic and renal function 5. Severe cardiac, hepatic and lung failure, and an attending doctor was considered unsuitable.

Design outcomes

Primary

Measure	Time frame
Evaluation of overall survival and QOL in patients given therapies with or without PSK based on HLA category types.	—

Secondary

Measure	Time frame
Evaluation of overall survival and QOL based on HLA category types in gastric and colorectal cancer.	—

Countries

Japan

Contacts

Public ContactKyoji Ogoshi

Tokai University Department of Surgery

ogoshi@is.icc.u-tokai.ac.jp0463-96-6163

Outcome results

None listed

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