NCT04992143

TACE+Tilelizumab+Sorafenib in the Treatment of BCLC Stage C HCC

Status unknown Phase 2 Last updated 16 February 2023

What this trial tests

Phase 2 trial testing TACE in BCLC Stage C Hepatocellular Carcinoma in 20 participants. Status unknown.

Timeline

20 August 2021

Primary endpoint
30 August 2023

30 December 2023

Quick facts

Lead sponsor	First Affiliated Hospital of Zhejiang University
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	20 August 2021
Primary completion	30 August 2023
Estimated completion	30 December 2023
Sites	1 location across China

Drugs / interventions tested

• TACE
• Tilelizumab — full drug profile →
• Sorafenib (SORAFENIB) — full drug profile →

Conditions studied

• BCLC Stage C Hepatocellular Carcinoma — all drugs for BCLC Stage C Hepatocellular Carcinoma →

Sponsor

First Affiliated Hospital of Zhejiang University

Who can join

18 and older, any sex, with BCLC Stage C Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

According to the BCLC staging system treatment recommendation, systemic treatment is recommended for patients in BCLC stage C, and TACE and systemic treatment are recommended for patients in this stage. Studies have shown that TACE combined with sorafenib therapy has shown effectiveness in the treatment of advanced liver cancer, and PD-1 inhibitors have also shown effectiveness in the treatment of advanced liver cancer. Therefore, in order to improve the survival benefit of BCLC stage C liver cancer patients, this clinical study was designed to evaluate the effectiveness and safety of TACE combined with sorafenib and tislelizumab in the treatment of BCLC stage C liver cancer patients.

Publications & conference data

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

1. The Significance of Transarterial Chemo(Embolization) Combined With Tyrosine Kinase Inhibitors and Immune Checkpoint Inhibitors for Unresectable Hepatocellular Carcinoma in the Era of Systemic Therapy: A Systematic Review.
   Ke Q, Xin F, Fang H, Zeng Y, et al · · 2022 · cited 40× · PMID 35677059 · DOI 10.3389/fimmu.2022.913464
2. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
3. Small-molecule-based targeted therapy in liver cancer.
   Ming Y, Gong Y, Fu X, Ouyang X, et al · · 2024 · cited 6× · PMID 39113358 · DOI 10.1016/j.ymthe.2024.08.001
4. Insights in Molecular Therapies for Hepatocellular Carcinoma.
   Heumann P, Albert A, Gülow K, Tümen D, et al · · 2024 · cited 5× · PMID 38791911 · DOI 10.3390/cancers16101831
5. Trial watch: immunotherapeutic strategies on the horizon for hepatocellular carcinoma.
   Koh B, Tan DJH, Lim WH, Wong JSL, et al · · 2023 · cited 4× · PMID 37284696 · DOI 10.1080/2162402x.2023.2214478
6. Clinical benefits of transarterial chemoembolization combined with tyrosine kinase and immune checkpoint inhibitors for unresectable hepatocellular carcinoma.
   Han F, Wang XH, Xu CZ. · · 2024 · cited 2× · PMID 39072161 · DOI 10.4251/wjgo.v16.i7.3308
7. T-cell Receptor Repertoire Analysis in the Context of Transarterial Chemoembolization Synergy with Systemic Therapy for Hepatocellular Carcinoma.
   Li J, Zhang Y, Hu L, Ye H, et al · · 2025 · cited 1× · PMID 39801788 · DOI 10.14218/jcth.2024.00238
8. The State of the Art in Combination Locoregional and Systemic Treatment Strategies for Hepatocellular Carcinoma: Recent Advancements and Future Horizons.
   Fazlollahi F, Carfora AD, King M, Wrasman ES, et al · · 2026 · PMID 41892200 · DOI 10.3390/curroncol33030172