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H101 Combined With TACE for Primary Hepatocellular Carcinoma With Portal Vein Thrombosis

Primary Purpose

Primary Hepatocellular Carcinoma, Portal Vein Thrombosis

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Recombinant human adenovirus type 5 + TACE
Sponsored by
Tianjin Medical University Cancer Institute and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Hepatocellular Carcinoma focused on measuring recombinant human adenovirus type 5, TACE

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ≥ 18 years and ≤ 75 years, regardless of gender; Patients with stage IIIa primary liver cancer diagnosed by histology or imaging; ECOG physical status score of 0-1; Expected survival time ≥ 3 months; Received no liver protective and supportive treatment within two weeks before enrollment, and met the following conditions: White blood cell count ≥3.0×109/L, neutrophil absolute value ≥3.0×109/L, platelet count ≥50×109/L, hemoglobin > 100g/L; INR≤1.5 and APTT≤1.5 upper limit of normal or partial prothrombin time (PTT) ≤1.5 upper limit of normal; Total bilirubin (TBIL) ≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value; Serum creatinine ≤1.5 times the upper limit of normal value; Creatinine clearance ≥50ml/min. Voluntary participation in this study and signing of the informed consent form; Female patients of childbearing age or male patients whose sexual partners are women of childbearing age are required to use effective contraception throughout the treatment period and for 6 months after the last dose. Exclusion Criteria: Pregnant or lactating women, men or women who do not wish to use effective contraception; Patients who have received previous treatment with lysoviruses (e.g., T-VEC), interventional therapy, or TACE; Those who are being treated with antiviral drugs; having received any other experimental drug, antimicrobial drug, or participated in another interventional clinical trial within 4 weeks prior to enrollment Those with a known allergy to the study drug or its active ingredient, or a history of allergy to similar biological agents Evidence of Child-Pugh C hepatic function or hepatocellular dysregulation, including those with refractory ascites, ruptured esophageal or gastric variceal bleeding, and hepatic encephalopathy presence of a history of immunodeficiency or autoimmune disease or long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to enrollment With any unstable systemic disease, including but not limited to: severe infection, hypertensive patients, uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia, abnormal mental status or active cerebral hemorrhage, myocardial infarction, congestive heart failure, severe arrhythmias requiring drug therapy, renal or metabolic disease, severe hepatic dysfunction (including severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome), multiple organ failure with renal dysfunction; Previous or concurrent other malignancies; Combined medical contraindications that preclude any contrast-enhanced imaging (CT or MRI); Other conditions that, in the judgment of the investigator, make the patient unsuitable for participation in this study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Recombinant human adenovirus type 5 combined with TACE

    Arm Description

    Recombinant human adenovirus type 5: The recombinant human adenovirus type 5 injection is administered intratumorally 48-72h prior to TACE treatment. The recombinant human adenovirus type 5 injection was diluted to 30% of the total tumor volume with saline before administration. TACE: Chemotherapeutic drugs were specifically oxaliplatin 85 mg/m2, calcium folinic acid 400 mg/m2, 5-fluorouracil 1200 mg/m2, and then superfluid iodinated oil bolus was given according to the intraoperative imaging tumor blood supply.

    Outcomes

    Primary Outcome Measures

    disease control rate (DCR)
    The percentage of patients whose tumors shrank or stabilized and remained for a certain period of time, including cases in complete remission (CR), partial remission (PR), and stable (SD)

    Secondary Outcome Measures

    progress free survival(PFS)
    The time between the start of randomization and the onset of (any aspect of) tumor progression or death (from any cause)
    overall survival(OS)
    The time from randomization to death (from any cause)

    Full Information

    First Posted
    April 23, 2023
    Last Updated
    May 14, 2023
    Sponsor
    Tianjin Medical University Cancer Institute and Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05872841
    Brief Title
    H101 Combined With TACE for Primary Hepatocellular Carcinoma With Portal Vein Thrombosis
    Official Title
    Efficacy and Safety of Recombinant Human Adenovirus Type 5 Injection in Combination With TACE-based Combination Therapy in Patients With Stage IIIa Primary Hepatocellular Carcinoma With Portal Vein Thrombosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    June 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tianjin Medical University Cancer Institute and Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This study is the first to compare the efficacy and safety of recombinant human adenovirus type 5 injection via hepatic artery infusion combined with TACE-based combination therapy for the treatment of patients with stage IIIa primary hepatocellular carcinoma with portal vein carcinoma thrombosis, providing a safe and reliable treatment method for the clinical treatment of this group of patients, and also providing a reference and basis for the treatment of other tumors with this new treatment model.
    Detailed Description
    This is a prospective, single-arm study to evaluate the efficacy and safety of recombinant human adenovirus type 5 injection combined with TACE-based combination therapy in patients with stage IIIa primary hepatocellular carcinoma with portal vein carcinoma thrombosis. Subjects will be examined and evaluated at the study center, and after meeting the inclusion criteria, patients will be enrolled in a combination of recombinant human adenovirus type 5 injection via hepatic artery infusion and TACE regimen. The study is divided into screening period, baseline period, treatment period, and follow-up period. Follow-up after the end of treatment will be every 3 months until death or the end of this study. The primary study endpoint of this study is disease control rate (DCR) (up to 1 year), while progression free survival (PFS) (up to 1 year), 1-year overall survival rate, and distant metastasis rate are observed, and adverse events occurring during the study period are monitored for safety Data analysis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Primary Hepatocellular Carcinoma, Portal Vein Thrombosis
    Keywords
    recombinant human adenovirus type 5, TACE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    38 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Recombinant human adenovirus type 5 combined with TACE
    Arm Type
    Experimental
    Arm Description
    Recombinant human adenovirus type 5: The recombinant human adenovirus type 5 injection is administered intratumorally 48-72h prior to TACE treatment. The recombinant human adenovirus type 5 injection was diluted to 30% of the total tumor volume with saline before administration. TACE: Chemotherapeutic drugs were specifically oxaliplatin 85 mg/m2, calcium folinic acid 400 mg/m2, 5-fluorouracil 1200 mg/m2, and then superfluid iodinated oil bolus was given according to the intraoperative imaging tumor blood supply.
    Intervention Type
    Drug
    Intervention Name(s)
    Recombinant human adenovirus type 5 + TACE
    Other Intervention Name(s)
    H101+TACE
    Intervention Description
    Recombinant human adenovirus type 5 : Recombinant human adenovirus type 5 injection is administered intratumorally 48-72h prior to TACE treatment.Before administration, the recombinant human adenovirus type 5 injection was diluted to 30% of the total tumor volume with normal saline. H101 dose: ① The sum of the maximum diameters of the lesions was ≤10cm, and the total dose was 1. 0×1012vp (2 injections); ② The sum of the maximum diameters of the lesions was >10cm, and the total dose was 1. 5×1012vp (3 injections); TACE:The specific chemotherapeutic drugs were: oxaliplatin 85mg/m2, calcium folinic acid 400mg/m2, 5-fluorouracil 1200mg/m2, followed by superfluid iodinated oil bolus according to the intraoperative contrast tumor blood supply. Recombinant human adenovirus type 5 was administered in combination with TACE in cycles of every 3 weeks for a total of 2-4 cycles.
    Primary Outcome Measure Information:
    Title
    disease control rate (DCR)
    Description
    The percentage of patients whose tumors shrank or stabilized and remained for a certain period of time, including cases in complete remission (CR), partial remission (PR), and stable (SD)
    Time Frame
    Up to 1 year
    Secondary Outcome Measure Information:
    Title
    progress free survival(PFS)
    Description
    The time between the start of randomization and the onset of (any aspect of) tumor progression or death (from any cause)
    Time Frame
    Up to 1 year
    Title
    overall survival(OS)
    Description
    The time from randomization to death (from any cause)
    Time Frame
    Up to 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age ≥ 18 years and ≤ 75 years, regardless of gender; Patients with stage IIIa primary liver cancer diagnosed by histology or imaging; ECOG physical status score of 0-1; Expected survival time ≥ 3 months; Received no liver protective and supportive treatment within two weeks before enrollment, and met the following conditions: White blood cell count ≥3.0×109/L, neutrophil absolute value ≥3.0×109/L, platelet count ≥50×109/L, hemoglobin > 100g/L; INR≤1.5 and APTT≤1.5 upper limit of normal or partial prothrombin time (PTT) ≤1.5 upper limit of normal; Total bilirubin (TBIL) ≤2.5 times the upper limit of normal value; ALT and AST≤5 times the upper limit of normal value; Serum creatinine ≤1.5 times the upper limit of normal value; Creatinine clearance ≥50ml/min. Voluntary participation in this study and signing of the informed consent form; Female patients of childbearing age or male patients whose sexual partners are women of childbearing age are required to use effective contraception throughout the treatment period and for 6 months after the last dose. Exclusion Criteria: Pregnant or lactating women, men or women who do not wish to use effective contraception; Patients who have received previous treatment with lysoviruses (e.g., T-VEC), interventional therapy, or TACE; Those who are being treated with antiviral drugs; having received any other experimental drug, antimicrobial drug, or participated in another interventional clinical trial within 4 weeks prior to enrollment Those with a known allergy to the study drug or its active ingredient, or a history of allergy to similar biological agents Evidence of Child-Pugh C hepatic function or hepatocellular dysregulation, including those with refractory ascites, ruptured esophageal or gastric variceal bleeding, and hepatic encephalopathy presence of a history of immunodeficiency or autoimmune disease or long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to enrollment With any unstable systemic disease, including but not limited to: severe infection, hypertensive patients, uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia, abnormal mental status or active cerebral hemorrhage, myocardial infarction, congestive heart failure, severe arrhythmias requiring drug therapy, renal or metabolic disease, severe hepatic dysfunction (including severe jaundice, hepatic encephalopathy, refractory ascites or hepatorenal syndrome), multiple organ failure with renal dysfunction; Previous or concurrent other malignancies; Combined medical contraindications that preclude any contrast-enhanced imaging (CT or MRI); Other conditions that, in the judgment of the investigator, make the patient unsuitable for participation in this study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tongguo Si
    Phone
    18622228655
    Email
    drsitg@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tongguo Si
    Organizational Affiliation
    Tianjin Medical University Cancer Institute and Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    H101 Combined With TACE for Primary Hepatocellular Carcinoma With Portal Vein Thrombosis

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