Randomized controlled trial to evaluate the effectiveness of immunotherapy in gastric cancer based on preoperative serum glycoproteins: acute phase reactants (APRs).

Randomized controlled trial to evaluate the effectiveness of immunotherapy in gastric cancer based on preoperative serum glycoproteins: acute phase reactants (APRs). - Randomized controlled trial based on preoperative serum glycoproteins (PSGP trial).

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000037472

Enrollment

800

Registered

2019-07-29

Start date

1987-02-01

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

Gastric cancer

Interventions

PSK(-) PSK(+): PSK was administered orally from 14 days after gastrectomy at a dose of 3.0g/day and at least at a dose of over 270g. Fluoropyrimidine prodru (5-FU 150mg/day or FT (600mg/day or HCF

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Biopsy-proven primary gastric adenocarcinoma patients who gave informed consent.

Exclusion criteria

Exclusion criteria: 1. Double cancer. 2. Prior cytotoxic or radiation therapy. 3. Abnormal bone marrow, hepatic and renal function 4. Severe cardiac, hepatic and lung failure, and an attending doctor was considered unsuitable.

Design outcomes

Primary

Measure	Time frame
Five year overall survival after gastrectomy according to the combinatory CEA and APRs.	—

Secondary

Measure	Time frame
Overall survival according to HLA antigens.	—

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