Primary Hepatocellular CarcinomaPhase 2NCT05872841
H101 Combined With TACE for Primary Hepatocellular Carcinoma With Portal Vein Thrombosis
A Phase 2 study testing Recombinant human adenovirus type 5 + TACE in people with Primary Hepatocellular Carcinoma and Portal Vein Thrombosis, run by Tianjin Medical University Cancer Institute and Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Hepatocellular Carcinoma, Portal Vein Thrombosis
- What is being tested?
- Recombinant human adenovirus type 5 + TACE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2023to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- Recombinant human adenovirus type 5 + TACE
- Keywords
- recombinant human adenovirus type 5, TACE
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human adenovirus type 5 + TACEDrug
Also called H101+TACE
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant human adenovirus type 5 combined with TACE | Experimental | 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. Receives: Drug: Recombinant human adenovirus type 5 + TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 1 year
Secondary outcomes (2)
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)
Measured: Up to 1 year
overall survival(OS)
The time from randomization to death (from any cause)
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2023
- Study start1 Jun 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tongguo Si, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05872841
- Sponsor's protocol ID
- EC-2023-0009
- Status last verified
- Jul 2022
- First submitted
- 23 Apr 2023
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05872841
- Acronym / sponsor ID
- EC-2023-0009
- Keywords
- recombinant human adenovirus type 5, TACE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recombinant human adenovirus type 5 combined with TACE | Experimental | Drug: Recombinant human adenovirus type 5 + TACERecombinant 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human adenovirus type 5 + TACEAlso: H101+TACE1. 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); 2. 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. | Drug | Recombinant human adenovirus type 5 combined with TACE |
Primary outcome
disease control rate (DCR)
Time frame: Up to 1 year
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)
2 secondary outcomes
progress free survival(PFS)
Time frame: Up to 1 year
overall survival(OS)
Time frame: Up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tongguo Si principal investigator
Tianjin Medical University Cancer Institute and Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant human adenovirus type 5 + TACE in people with Primary Hepatocellular Carcinoma and Portal Vein Thrombosis, run by Tianjin Medical University Cancer Institute and Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tongguo Si (18622228655, drsitg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease control rate (DCR) (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.