NCT04652440

Ablation Combined With PD-1 in HCC: Phase II Study

Status unknown Phase 1, PHASE2 Last updated 19 April 2023

What this trial tests

Phase 1, PHASE2 trial testing PD-1 monoclonal antibody in Hepatocellular Carcinoma in 30 participants. Status unknown.

Timeline

15 December 2020

Primary endpoint
31 December 2023

30 June 2024

Quick facts

Lead sponsor	Sun Yat-sen University
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	15 December 2020
Primary completion	31 December 2023
Estimated completion	30 June 2024
Sites	1 location across China

Drugs / interventions tested

• PD-1 monoclonal antibody — full drug profile →
• Radiofequencey or microwave ablation

Conditions studied

• Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Sun Yat-sen University

Who can join

Adults 18 to 75, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 2, single arm, single center study designed to evaluate the safety and tolerability of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with hepatocellular carcinoma(HCC), with the secondary study objective to preliminarily evaluate the efficacy of radiofrequency or microwave ablation combined with PD-1 monoclonal antibody in patients with HCC and the exploratory study objective to evaluate the effect of ablation combined with PD-1 monoclonal antibody on immune function and hepatitis virus infection status in patients with HCC. This study will be divided into two stages, and the first stage is to enroll 6 patients for dose-limited toxicity (DLT) observation. If DLT appeared in \< 2 patients, the second stage was entered and the other 24 patients were further enrolled.

Publications & conference data

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

1. Advances in Immunotherapy for Hepatocellular Carcinoma (HCC).
   Bicer F, Kure C, Ozluk AA, El-Rayes BF, et al · · 2023 · cited 30× · PMID 37999131 · DOI 10.3390/curroncol30110711
2. Hyperthermia combined with immune checkpoint inhibitor therapy: Synergistic sensitization and clinical outcomes.
   Liu P, Ye M, Wu Y, Wu L, et al · · 2023 · cited 26× · PMID 35908281 · DOI 10.1002/cam4.5085
3. Combinatory local ablation and immunotherapies for hepatocellular carcinoma: Rationale, efficacy, and perspective.
   Chen S, Zeng X, Su T, Xiao H, et al · · 2022 · cited 22× · PMID 36505437 · DOI 10.3389/fimmu.2022.1033000
4. Local and Regional Therapies for Hepatocellular Carcinoma and Future Combinations.
   Hatzidakis A, Müller L, Krokidis M, Kloeckner R. · · 2022 · cited 17× · PMID 35626073 · DOI 10.3390/cancers14102469
5. Combination Therapy of Immune Checkpoint Inhibitors with Locoregional Therapy for Hepatocellular Carcinoma.
   Tamai Y, Fujiwara N, Tanaka T, Mizuno S, et al · · 2023 · cited 13× · PMID 37894439 · DOI 10.3390/cancers15205072
6. Immunotherapy for advanced hepatocellular carcinoma: From clinical trials to real-world data and future advances.
   Rallis KS, Makrakis D, Ziogas IA, Tsoulfas G. · · 2022 · cited 13× · PMID 35949435 · DOI 10.5306/wjco.v13.i6.448
7. Combining energy-based focal ablation and immune checkpoint inhibitors: preclinical research and clinical trials.
   Jiang M, Fiering S, Shao Q. · · 2023 · cited 7× · PMID 37251920 · DOI 10.3389/fonc.2023.1153066
8. <i>In-situ</i> tumor vaccination by percutaneous ablative therapy and its synergy with immunotherapeutics: An update on combination therapy.
   Kim NJ, Yoon JH, Tuomi AC, Lee J, et al · · 2023 · cited 6× · PMID 36969248 · DOI 10.3389/fimmu.2023.1118845