Effect and Safety of Recombinant Human Adenovirus Type 5 in Advanced HCC With Stable Disease After Sorafenib Treatment

• Status: Not yet recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University
• Treatments: Sorafenib

Criteria

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