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

NCT05113290 | Unknown Phase 4

• 1 other identifier: XJTU1AF2021LSK-160
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Hepatocellular Carcinoma

Keywords

oncolytic virus

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR) according to mRECIST criteria

  MRECIST criteria are based on traditional RECIST V1.0 and combined with specific assessment of hepatocellular carcinoma (HCC) (active lesions vs. Necrosis/fibrous nodules) to evaluate the efficacy of HCC

  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)

Secondary Outcomes (5)

• Changes from baseline in alpha-fetoprotein (AFP) serum levels

  1 year

• Disease control rate (DCR)

  From the first administration of the study drug to disease progression, occurrence of unacceptable toxicity, withdrawal of informed consent or termination of the study (up to 1 year)

• Progression-free survival (PFS)

  up to 1 year

• 1 year survival rate

  1 year

• Number of participants with adverse events

  1 year

Study Arms (2)

H101+Sorafenib

EXPERIMENTAL

H101 combined with Sorafenib

Drug: Recombinant Human Adenovirus Type 5 injection; Drug: Sorafenib

Sorafenib

ACTIVE COMPARATOR

Patients take Sorafenib only

Drug: Sorafenib

Interventions

Recombinant Human Adenovirus Type 5 injection DRUG

Intratumoral injection of lesions with dose of 3 vials (1.5 × 10\^12 vp) if the sum of the maximum lesion diameters was \> 10 cm, 2 vials (1.0 × 10\^12 vp) if the sum of the maximum lesion diameters was ≤ 10 cm. The cycle is 21 days up to 2-5 cycles.

H101+Sorafenib

Sorafenib DRUG

Sorafenib will be administered as the original dose before enrollment, or be adjusted by the doctor according to the tolerance.

H101+Sorafenib; Sorafenib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (4)

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Location

Tangdu Hospital

Xi'an, Shaanxi, China

Location

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi'an, Shaanxi, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Sorafenib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Chang Liu, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2021
• First Posted: November 9, 2021
• Study Start: December 28, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: January 27, 2022

Record last verified: 2021-10

Locations

CN (4)