NCT03510871

Nivolumab Plus Ipilimumab as Neoadjuvant Therapy for Hepatocellular Carcinoma (HCC)

Completed Phase 2 Last updated 8 July 2024

What this trial tests

Phase 2 trial testing nivolumab, ipilimumab in Hepatocellular Carcinoma (HCC) in 43 participants. Completed in 31 May 2024.

Timeline

12 February 2019

Primary endpoint
31 May 2024

31 May 2024

Quick facts

Lead sponsor	National Health Research Institutes, Taiwan
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	43
Start date	12 February 2019
Primary completion	31 May 2024
Estimated completion	31 May 2024
Sites	8 locations across Taiwan

Drugs / interventions tested

• nivolumab, ipilimumab

Conditions studied

• Hepatocellular Carcinoma (HCC) — all drugs for Hepatocellular Carcinoma (HCC) →

Sponsor

National Health Research Institutes, Taiwan

Who can join

20 and older, any sex, with Hepatocellular Carcinoma (HCC). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Objectives:

1. To evaluate the efficacy, in terms of tumor shrinkage, objective response rate, and down-stage rate, of nivolumab + ipilimumab as neoadjuvant therapy for patients with HCC;
2. To evaluate the safety profile in patients with HCC who receive neoadjuvant nivolumab + ipilimumab treatment;
3. To collect HCC tumor tissue and peripheral blood samples from the patients for a comprehensive biomarker evaluation for nivolumab + ipilimumab immunotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Immunosuppressive cells in cancer: mechanisms and potential therapeutic targets.
   Tie Y, Tang F, Wei YQ, Wei XW. · · 2022 · cited 386× · PMID 35585567 · DOI 10.1186/s13045-022-01282-8
2. Current perspectives on the immunosuppressive tumor microenvironment in hepatocellular carcinoma: challenges and opportunities.
   Lu C, Rong D, Zhang B, Zheng W, et al · · 2019 · cited 327× · PMID 31464625 · DOI 10.1186/s12943-019-1047-6
3. Emerging Therapies for Hepatocellular Carcinoma (HCC).
   Chakraborty E, Sarkar D. · · 2022 · cited 236× · PMID 35681776 · DOI 10.3390/cancers14112798
4. Hepatocellular Carcinoma Immune Landscape and the Potential of Immunotherapies.
   Giraud J, Chalopin D, Blanc JF, Saleh M. · · 2021 · cited 172× · PMID 33815418 · DOI 10.3389/fimmu.2021.655697
5. Inflammatory Mechanisms of HCC Development.
   Refolo MG, Messa C, Guerra V, Carr BI, et al · · 2020 · cited 149× · PMID 32164265 · DOI 10.3390/cancers12030641
6. Angiogenesis and immune checkpoint inhibitors as therapies for hepatocellular carcinoma: current knowledge and future research directions.
   Hilmi M, Neuzillet C, Calderaro J, Lafdil F, et al · · 2019 · cited 123× · PMID 31783782 · DOI 10.1186/s40425-019-0824-5
7. Hepatocellular carcinoma: updates on epidemiology, surveillance, diagnosis and treatment.
   Hwang SY, Danpanichkul P, Agopian V, Mehta N, et al · · 2025 · cited 96× · PMID 39722614 · DOI 10.3350/cmh.2024.0824
8. Immunotherapy for Hepatocellular Carcinoma: A 2021 Update.
   Kole C, Charalampakis N, Tsakatikas S, Vailas M, et al · · 2020 · cited 88× · PMID 33020428 · DOI 10.3390/cancers12102859