NCT05225116 is a Phase 1 clinical trial of Sintilimab in Hepatocellular Carcinoma, sponsored by Beijing Tsinghua Chang Gung Hospital.

Who is sponsoring NCT05225116?

NCT05225116 is sponsored by Beijing Tsinghua Chang Gung Hospital.

What drugs are being tested in NCT05225116?

Interventions in NCT05225116: Sintilimab, Lenvatinib, radiotherapy.

What condition does NCT05225116 study?

NCT05225116 studies Hepatocellular Carcinoma.

Is NCT05225116 still recruiting?

NCT05225116 is currently status unknown. Last updated 8 February 2023.

Last reviewed 2023-02-08 · How we verify

NCT05225116

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy of Lenvatinib and Anti-PD1 Antibody Combined With Radiotherapy Neoadjuvant Treatment for Resectable Hepatocellular Carcinoma With PVTT

Status unknown Phase 1 Last updated 8 February 2023

What this trial tests

Phase 1 trial testing Sintilimab in Hepatocellular Carcinoma in 20 participants. Status unknown.

Timeline

8 January 2023

Primary endpoint
5 December 2025

5 December 2025

Quick facts

Lead sponsor	Beijing Tsinghua Chang Gung Hospital
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	8 January 2023
Primary completion	5 December 2025
Estimated completion	5 December 2025
Sites	1 location across China

Drugs / interventions tested

Sintilimab — full drug profile →
Lenvatinib (LENVATINIB) — full drug profile →
radiotherapy — full drug profile →

Conditions studied

Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →

Sponsor

Beijing Tsinghua Chang Gung Hospital

Who can join

Adults 18 to 70, any sex, with Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with hepatocellular carcinoma with PVTT can benefit from surgical resection and radiotherapy. As the rapid development of systematic treatment in hepatocellular carcinoma, ICIs neoadjuvant therapy is being actively explored .But there is no evidence to prove the safety and efficacy of lenvatinib and anti-PD1 antibody combined with radiotherapy neoadjuvant treatment for resectable hepatocellular carcinoma with PVTT. This study intends to supplement the evidence of benefit in such patients.

Publications & conference data

8 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
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
Neoadjuvant systemic therapy for hepatocellular carcinoma.
Chick RC, Ruff SM, Pawlik TM. · · 2024 · cited 16× · PMID 38495884 · DOI 10.3389/fimmu.2024.1355812
Radiation and Immune Checkpoint Inhibitors: Combination Therapy for Treatment of Hepatocellular Carcinoma.
Chami P, Diab Y, Khalil DN, Azhari H, et al · · 2023 · cited 13× · PMID 38069095 · DOI 10.3390/ijms242316773
Neoadjuvant and Adjuvant Systemic Therapies in Loco-Regional Treatments for Hepatocellular Carcinoma: Are We at the Dawn of a New Era?
Nevola R, Delle Femine A, Rosato V, Kondili LA, et al · · 2023 · cited 12× · PMID 37296912 · DOI 10.3390/cancers15112950
Real-World Use of Immunotherapy for Hepatocellular Carcinoma.
Sara A, Ruff SM, Noonan AM, Pawlik TM. · · 2023 · cited 8× · PMID 37637511 · DOI 10.2147/por.s397972
Safety and efficacy of radiotherapy combined with lenvatinib plus PD-1 inhibitors as neo-adjuvant therapy in hepatocellular carcinoma with portal vein thrombus: protocol of an open-label, single-arm, prospective, multi-center phase I trial.
Li G, Shu B, Zheng Z, Yin H, et al · · 2022 · cited 6× · PMID 36505833 · DOI 10.3389/fonc.2022.1051916
Adjuvant and Neoadjuvant Treatments for Resectable Hepatocellular Carcinoma.
Crook CJ, Li D. · · 2023 · cited 5× · PMID 37688739 · DOI 10.1007/s11912-023-01455-9

Verify or expand the search:

Other trials of Sintilimab

Trials testing the same drug.

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
NCT07537946 — Local Consolidation After Sintilimab Plus Lenvatinib for Metastatic Liver Cancer · Phase 3 · not yet recruiting
NCT07537972 — Denosumab Strategy for Liver Cancer With Bone Metastases · Phase 2 · not yet recruiting
NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma · Phase 2 · recruiting
NCT07515625 — Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesop · Phase 2 · not yet recruiting

Other recruiting trials for Hepatocellular Carcinoma

Currently open trials in the same condition.

NCT06902246 — Regorafenib and Yttrium-90 Radioembolization for Unresectable Hepatocellular Carcinoma · Phase 2 · recruiting
NCT05842174 — Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma · Phase 1, PHASE2 · recruiting
NCT07417397 — Adjuvant TACE in HCC With High-risk Recurrence Factors · Phase 3 · recruiting
NCT07317414 — β-alanine in the Treatment of Advanced Hepatocellular Carcinoma · Phase 2 · recruiting
NCT07148050 — Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimer · Phase 1 · recruiting

Other Beijing Tsinghua Chang Gung Hospital trials

Trials by the same sponsor.

NCT07123675 — AI-Assisted Blood Pressure Control During Anesthesia · NA · not yet recruiting
NCT07152496 — Host-Microbe Interactions in Biliary Dilatation · not yet recruiting
NCT07330271 — PTC-Guided Therapy for Peritoneal Mesothelioma · NA · recruiting
NCT07328737 — One vs Three HIPEC Cycles After CRS for Pseudomyxoma Peritonei · NA · recruiting
NCT07044947 — Oteseconazole in the Treatment of Adults With Vulvovaginal Candidiasis（VVC） · 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)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05225116 (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 Beijing Tsinghua Chang Gung Hospital
Last refreshed: 8 February 2023

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/NCT05225116.

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