Last reviewed · How we verify
NCT04850157
Tislelizumab Combined With IMRT Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT
Phase 2 trial testing Tislelizumab in Hepatocellular Carcinoma With Portal Vein Tumor Thrombus in 30 participants. Status unknown.
20 April 2022
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 20 April 2021 |
| Primary completion | 20 April 2022 |
| Estimated completion | 20 December 2023 |
| Sites | 1 location across China |
Drugs / interventions tested
- Tislelizumab (TISLELIZUMAB) — full drug profile →
- IMRT
Conditions studied
- Hepatocellular Carcinoma With Portal Vein Tumor Thrombus — all drugs for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus →
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):
-
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 -
Neoadjuvant Therapy for Hepatocellular Carcinoma.
Yin Z, Chen D, Liang S, Li X. · · 2022 · cited 22× · PMID 36068876 · DOI 10.2147/jhc.s357313 -
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 -
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 -
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 -
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
Verify or expand the search:
- PubMed search for NCT04850157
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tislelizumab
Trials testing the same drug.
- NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
- NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
- NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
- NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
- NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting
Other Shanghai Zhongshan Hospital trials
Trials by the same sponsor.
- NCT07353476 — Radiotherapy Plus Anti-PD-1 Versus Anti-PD-1 Alone in ypTanyN⁺M0 NSCLC · Phase 2 · not yet recruiting
- NCT07508956 — Feasibility of Circulating Tumor DNA Based Minimal Residual Disease-Guided Adjuvant Therapy in Locally Advanced Gastric · Phase 3 · not yet recruiting
- NCT07535632 — SBRT Followed by PD-1 Inhibitor, Bevacizumab and TAS-102 as Third-Line Therapy for Recurrent/Metastatic Colorectal Cance · Phase 2 · not yet recruiting
- NCT07531368 — BBAP With CS Mapping Guidance · NA · not yet recruiting
- NCT07501104 — Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04850157 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 20 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04850157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing