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Efficacy of adoptive cellular therapy with naive rich T cell on recurrence after curative radiofrequency ablation for primary hepatocellular carcinoma (Phase 2 study)

Efficacy of adoptive cellular therapy with naive rich T cell on recurrence after curative radiofrequency ablation for primary hepatocellular carcinoma (Phase 2 study) - HCC prevention study by naive rich T cell therapy

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000003861
Enrollment
25
Registered
2010-07-05
Start date
2010-07-01
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

Hepatocellular carcinoma

Interventions

Sponsors

Kyoto Prefectural University of Medicine, Division of Gastroenterology and Hepatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: The following HCC patients who are curatively treated with RFA. 1. not less than 20, less than 80 years of age. 2. Performance status of the patients are 0-2. 3. Child-Pugh class A or B. 4. Bone marrow function and hepatic/renal functions are well maintained. a White blood cell count more than 2000/mm3, less than 10000/mm3. b. Platelet count more than 50000/mm3. c. AST and ALT less than 150IU/L d. T. Bil less than 3.0mg/dl. e. Cr less than 1.5mg/dl 5. All patients gave written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patient who has uncontrollable severe infectional disease. 2. Patient who has allergic disease or autoimmune disease requiring treatment. 3. Patient who is associated with malignant hypertension, severe congestive heart disease, unsatble angina, myocardial infarction within 6 months prio to registration, severe pulmonary fibrosis and active interstitial pneumonia. 4. Patient who cannot undergo enhanced CT scan or MRI due to some reason such as allergy for contrast media or renal dysfunction. 5. Patient who has uncontrollable associated cancer. 6.Patient with severe drug allergy. 7.Patient with severe psychiatric disorder. 8.In pregnancy or lactation. 9. Patient with HIV or HTLV-1 infection. 10.Patient who is inappropriate.

Design outcomes

Primary

MeasureTime frame
Three-year recurrence-free survival

Secondary

MeasureTime frame
overall survival, disease-specific survival, immunological response, safety

Countries

Japan

Contacts

Public ContactTakeshi Ishikawa

Kyoto Prefectural University of Medicine Division of Gastroenterology and Hepatology

iskw-t@koto.kpu-m.ac.jp075-251-5519

Outcome results

None listed

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