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Adjuvant Treatment with nivolumab in the Prevention of recurrence after curative treatment of Hepatocellular Carcinoma(NIVOLVE)

Adjuvant Treatment with nivolumab in the Prevention of recurrence after curative treatment of Hepatocellular Carcinoma(NIVOLVE) - NIVOLVE

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026648
Enrollment
55
Registered
2017-03-23
Start date
2017-02-28
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

Nivolumab is administered intravenously

Sponsors

Kindai University Faculty of Medicine Department of Gastroenterology and Hepatology
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Initially diagnosed hepatocellular carcinoma with histological or radiological confirmation. 2.Intermediate or High Risk of recurrence as assessed by tumor characteristics. 3.Child-Pugh A 4.ECOG Performance Status of 0. 5.Adequate bone marrow, liver and renal function 6.Written informed concent

Exclusion criteria

Exclusion criteria: 1.History of treatment except for hepatic resection of RFA 2.History or present of autoimmune disease 3.History or present of inestitial neumonia 4.History of malignancy 5.Renal falure 6.severe heart disease 7.severe hypertension 8.active infection 9.History of treatment using immunotherapy such as immune checkpoint inhibitor, peptide vaccine, biochemical modulator and Lymphocyte stimulation therapy 10.pregnancy or breast feeding

Design outcomes

Primary

MeasureTime frame
1-year recurrence free survival rate

Secondary

MeasureTime frame
Reccurence free survival 2-year recurrence free survival rate Overall survival Tumor markers Safety

Countries

Japan

Contacts

Public ContactKazuomi Ueshima

Kindai University Faculty of Medicine Gastroenterology and Hepatology

051012@med.kindai.ac.jp072-288-7222

Outcome results

None listed

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