H101 Combined With TACE for Primary Hepatocellular Carcinoma With Portal Vein Thrombosis (NCT05872841) | Clinical Trial Compass
UnknownPhase 2
H101 Combined With TACE for Primary Hepatocellular Carcinoma With Portal Vein Thrombosis
38 participantsStarted 2023-06-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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:
✓. 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
What they're measuring
1
disease control rate (DCR)
Timeframe: Up to 1 year
Trial details
NCT IDNCT05872841
SponsorTianjin Medical University Cancer Institute and Hospital
✕. 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;