Clinical trial · Interventional
Effect and Safety of Recombinant Human Adenovirus Type 5 in Advanced HCC With Stable Disease After Sorafenib Treatment
Effect and Safety of Recombinant Human Adenovirus Type 5 (H101) in Advanced Hepatocellular Carcinoma Patients With Stable Disease After Sorafenib Treatment: A Randomized, Parallel-Controlled Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Sorafenib, as a first-line treatment for patients with advanced HCC, can significantly prolong the overall survival rate of patients. However, about 53-71% of patients showed stable disease (SD) after sorafenib treatment, and further studies to explore optimal therapy for these patients are still needed. Oncolytic viruses are a type of virus that can selectively replicate in tumor cells and then destroy tumor cells, of which recombinant human adenovirus type 5 (H101) is the first oncolytic virus drug which was approved in the world. Recent studies indicate that H101 shows anti-tumor effects on liver cancer and there may be a synergistic effect between recombinant human adenovirus type 5 and sorafenib in the inhabitation of hepatoma cells in vitro. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with sorafenib in the treatment of advanced hepatocellular carcinoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Recombinant Human Adenovirus Type 5 injection | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- H101+Sorafenib
- description
- H101 combined with Sorafenib
- interventionNames
- Drug: Recombinant Human Adenovirus Type 5 injection
- Drug: Sorafenib
- type
- ACTIVE_COMPARATOR
- label
- Sorafenib
- description
- Patients take Sorafenib only
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Objective response rate (ORR) according to mRECIST criteria
- timeFrame
- From the first administration of the study drug to disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent or termination of the study (assessed up to 24 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 years and ≤ 70 years of age, male or female * Histologically/radiologically diagnosed advanced unresectable hepatocellular carcinoma * Patients had received sorafenib as systemic therapy for advanced HCC with radiographic assessment of Stable Disease (SD) according to mRECIST criteria * ECOG performance status of 0-2 * Child-Pugh score ≤ 7 * At least one measurable target lesion according to mRECIST and at least one lesion ≥ 10 mm; the lesions previously treated by radiotherapy or local regional therapy must have imaging evidence of disease progression to be considered as target lesions * Life expectancy ≥ 3 months * A) White blood cell count ≥ 3.0 × 10 \^ 9/L, absolute neutrophil count ≥ 3.0 × 10 \^ 9/L, platelet count ≥ 50 × 10 \^ 9/L, hemoglobin \> 100 g/L; B) INR ≤ 1.5 times the upper limit of normal, APTT ≤ 1.5 times the upper limit of normal or PTT ≤ 1.5 times the upper limit of normal; C) Total bilirubin ≤ 2.5 times the upper limit of normal; ALT and AST ≤ 5 times the upper limit of normal; serum creatinine ≤ 1.5 times the upper limit of normal * Voluntarily participate in this study and sign the informed consent * Female patients of childbearing age or male patients with sexual partners of childbearing age should take effective contraceptive measures throughout the treatment period and 6 months after treatment Exclusion Criteria: * Pregnant or lactating women * Diffuse liver cancer or tumor not amenable to mRECIST criteria * Prior treatment with oncolytic virus (e.g., T-VEC) * Patients who are known to be allergic to the study drug or its active ingredients * Sorafenib administration \< 14 days * History of immunodeficiency or autoimmune disease, or chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to enrollment * Patients with any other unstable systemic disease or other malignancy that may reduce life expectancy * Patients participate in another interventional clinical trial within 30 days
References
Publications (0)
Data not yet available