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NCT04850157

Tislelizumab Combined With IMRT Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT

Status unknown Phase 2 Last updated 20 April 2021
What this trial tests

Phase 2 trial testing Tislelizumab in Hepatocellular Carcinoma With Portal Vein Tumor Thrombus in 30 participants. Status unknown.

Timeline
20 April 2021
Primary endpoint
20 April 2022
20 December 2023

Quick facts

Lead sponsorShanghai Zhongshan Hospital
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment30
Start date20 April 2021
Primary completion20 April 2022
Estimated completion20 December 2023
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Shanghai Zhongshan Hospital

Who can join

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

Sponsor's own description

Due to the biological characteristics and liver anatomical characteristics of liver cancer, liver cancer cells easily invade the vascular system, especially the portal venous system, forming portal vein tumor thrombus (PVTT) , and its incidence is reported to be 44.0% \~ 62.2%. Once PVTT occurs in patients with liver cancer, the disease develops rapidly, and intrahepatic and extrahepatic metastasis, portal hypertension, jaundice, and abdominal effusion can occur in a short time with an average survival time of 2.7 months. PVTT is one of the major adverse factors for the prognosis of liver cancer and occupies an important weight influence in the clinical staging system of liver cancer. In some hepatocellular carcinoma (HCC) patients with PVTT and selective resectability, surgery versus non-surgery can lead to better survival of patients. A retrospective analysis showed that neoadjuvant radiotherapy can reduce the extent of invasion of PVTT and improve postoperative survival in some HCC patients. Another prospective study showed that neoadjuvant radiotherapy could significantly improve the overall survival of resectable liver cancer with PVTT, and neoadjuvant radiotherapy could improve the 2-year survival of patients from 9.4% to 27.4% 27.4%, with an effective response of 20.7%. This study is a prospective, single-center, single-arm study to assess the efficacy and safety of neoadjuvant therapy with tislelizumab combined with IMRT for resectable liver cancer with PVTT.

Publications & conference data

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

  1. Advances in radiotherapy and immunity in hepatocellular carcinoma.
    Yang Y, Xiong L, Li M, Jiang P, et al · · 2023 · cited 37× · PMID 37542324 · DOI 10.1186/s12967-023-04386-y
  2. Neoadjuvant Therapy for Hepatocellular Carcinoma.
    Yin Z, Chen D, Liang S, Li X. · · 2022 · cited 22× · PMID 36068876 · DOI 10.2147/jhc.s357313
  3. Systemic Neoadjuvant and Adjuvant Therapies in the Management of Hepatocellular Carcinoma-A Narrative Review.
    Chamseddine S, LaPelusa M, Kaseb AO. · · 2023 · cited 17× · PMID 37444618 · DOI 10.3390/cancers15133508
  4. Combination of radiotherapy and ICIs in advanced hepatocellular carcinoma: A systematic review of current evidence and future prospects (Review).
    Ma C, Yu X, Zhang X, Su L, et al · · 2025 · cited 4× · PMID 40438865 · DOI 10.3892/ol.2025.15088
  5. Efficacy and safety of the immune checkpoint inhibitor-radiotherapy combination in advanced/unresectable hepatocellular carcinoma: A systematic review and meta-analysis.
    Cui R, Yu X, Jiang Y, Li X. · · 2025 · cited 2× · PMID 40776902 · DOI 10.3892/ol.2025.15206
  6. Exploring potential predictive biomarkers through historical perspectives on the evolution of systemic therapies into the emergence of neoadjuvant therapy for the treatment of hepatocellular carcinoma.
    Wang C, Wei F, Sun X, Qiu W, et al · · 2024 · PMID 38993637 · DOI 10.3389/fonc.2024.1429919

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