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NCT06253598
Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma
Phase 2 trial testing Recombinant Human Adenovirus Type 5 in Hepatocellular Carcinoma in 30 participants. Not yet recruiting.
30 December 2025
Quick facts
| Lead sponsor | The First Affiliated Hospital of Bengbu Medical University |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 30 March 2024 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2026 |
Drugs / interventions tested
- Recombinant Human Adenovirus Type 5
- Lenvatinib (LENVATINIB) — full drug profile →
- Tislelizumab (TISLELIZUMAB) — full drug profile →
Conditions studied
- Hepatocellular Carcinoma — all drugs for Hepatocellular Carcinoma →
Sponsor
The First Affiliated Hospital of Bengbu Medical 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 prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. The recombinant human adenovirus type 5 was administered intratumorally on day 1 and 5 in cycle 1 and cycle 2. Lenvatinib was administered orally once daily started on day 1 of cycle 1 .Tislelizumab was administered intravenously every 3 week started on day 1 of cycle 3. The patient accepted the therapy until disease progression or unacceptable toxicity occurred or meet the end point of the study. The primary end point was ORR assessed by investigator using RECIST v1.1 .
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Research and Clinical Progress of Therapeutic Tumor Vaccines.
Dong C, Li Z, Tan D, Sun H, et al · · 2025 · cited 3× · PMID 40733649 · DOI 10.3390/vaccines13070672 -
Oncolytic virus therapy in hepatocellular carcinoma.
Ye Y, Liu Y. · · 2025 · PMID 40612869 · DOI 10.32604/or.2025.061857
Verify or expand the search:
- PubMed search for NCT06253598
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Recombinant Human Adenovirus Type 5
Trials testing the same drug.
- NCT05124002 — Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma · Phase 4 · unknown
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 The First Affiliated Hospital of Bengbu Medical University trials
Trials by the same sponsor.
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- NCT07330882 — Health Behavior Management Program for Patients With Coronary Heart Disease · NA · enrolling by invitation
- NCT06061614 — Safety and Efficacy Study of NGGT002 in PKU Adult Subjects · EARLY_PHASE1 · 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 NCT06253598 (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 The First Affiliated Hospital of Bengbu Medical University
- Last refreshed: 7 March 2024
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/NCT06253598.
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