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NOT YET RECRUITING
NCT07902258
PHASE2

An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable HCC

Sponsor: National Taiwan University Hospital

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate whether giving a single dose of Nivolumab (Opdivo®) before curative surgery for patients with resectable liver cancer can activate the body's immune response against the cancer and potentially reduce the risk of the cancer coming back after surgery, without delaying or affecting the planned surgery. The study will also evaluate whether this treatment is feasible and whether it may be effective. Participants will: * Complete all required examinations(e.g.: Laboratory tests, Tumor tissue biopsy, Computed tomography scan...) during the screening period * Receive single dose of Nivolumab intravenous infusion * Undergo surgery on its originally scheduled date * Visit the hospital once every 4 weeks for checkups and tests after receiving Nivolumab

Official title: An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable Hepatocellular Carcinoma (ONESHOT STUDY)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-11-02

Completion Date

2028-10-02

Last Updated

2026-10-28

Healthy Volunteers

No

Interventions

DRUG

Nivolumab

Nivolumab will be intravenously administered as a single dose of 240 mg with prophylactic corticosteroids consisting of intravenous betamethasone 8 mg or equivalent before nivolumab,and the curative surgery will proceed as originally scheduled whenever clinically feasible.

Locations (3)

National Taiwan University Hospital Hsin-Chu Branch(NTU BioMedical Park Hospital)

Hsinchu, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

National Taiwan University Cancer Center

Taipei, Taiwan