Hepatocellular CarcinomaPhase 2NCT06253598
Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma
A Phase 2 study testing Recombinant Human Adenovirus Type 5, Lenvatinib and Tislelizumab in people with Hepatocellular Carcinoma, run by The First Affiliated Hospital of Bengbu Medical University.
Trial summary
This prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Recombinant Human Adenovirus Type 5, Lenvatinib and Tislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2024to 30 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 old, and ≤75 years old, regardless of gender;
- Primary hepatocellular carcinoma confirmed by histology or imaging;
- Patients with advanced hepatocellular carcinoma who have not received oncolytic viruses, immutherapy drugs (including anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs), and systemic therapy (such as anti-VEGF /VEGFR monoclonal antibodies, anti- VEGFR-TKI drugs, chemotherapy);
- ECOG performance status 0-1;
- Child-Pugh score ≤7;
- There was at least one measurable target lesion according to RECIST 1.1 criteria, and at least one lesion was ≥ 10 mm;
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- The expected survival time was ≥3 months;
- Laboratory tests during the screening period met the following criteria:
- White blood cell count ≥ 3.0×10^9 /L, absolute neutrophil count ≥1.5×10^9/L, platelet count ≥ 75×10^9/L, hemoglobin > 90g/L
- INR≤1.5 and APTT≤1.5 times upper limit of normal or partial prothrombin time (PTT) ≤1.5 times upper limit of normal;
- Total bilirubin ≤2.5 times upper limit of normal; ALT and AST≤5 times upper limit of normal (ULN); Serum creatinine ≤1.5 times the upper limit of normal.
- They volunteered to participate in this study and signed informed consent.
Who cannot join
- Pregnant or lactating women, men or women unwilling to use effective contraception;
- Diffuse liver cancer or tumor is not suitable for RECIST 1.1 criteria;
- Patients who have previously received an oncolytic viral agent such as T-VEC;
- Known allergy to the study drug or its active ingredient, history of allergy to the same biological agent;
- HBV DNA quantitation ≥1000 copies.
- Imaging showed portal vein tumor thrombus more than half of the lumen, inferior vena cava tumor thrombus or heart involvement.
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- The patient has had grade ≥2 hepatic encephalopathy within 12 months or currently requires medication to prevent or control hepatic encephalopathy.
- Confirmed active tuberculosis (TB), known human immunodeficiency virus (HIV) positive patients, and other serious infections requiring treatment;
- A history of immunodeficiency or autoimmune disease, or long-term systemic steroid therapy or any form of immunosuppressive therapy within 7 days before enrollment;
- A history of other (including unknown primary) malignancies, except for Cured non- melanoma skin malignancies, carcinoma in situ of the cervix, radical stage I uterine cancer, radical ductal carcinoma in situ or lobular carcinoma in situ of the breast (without any systemic treatment), localized prostate cancer that is currently considered cured after radical surgery, and other solid tumors that have been treated with radical surgery for more than 5 years without evidence of recurrence;
- Known tumors of the central nervous system, including metastatic brain tumors;
- Accompanied by any unstable systemic disease, including but not limited to: Severe infections, patients with hypertension whose blood pressure cannot be lowered to normal after antihypertensive treatment, uncontrolled diabetes mellitus, unstable angina pectoris, cerebrovascular accident or transient ischemic attack, myocardial infarction (a history of myocardial infarction of 6 months or more is allowed), congestive heart failure, serious arrhythmias requiring medical treatment, renal or metabolic diseases;
- With medical contraindications to any contrast-enhanced imaging (CT or MRI);
- Participants who had participated in an interventional clinical trial within 30 days before screening (Note: Participants who were already in the follow-up phase of the clinical trial could participate in this trial if it was 4 weeks after the last dose of the previous investigational drug).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma: a Single-center, Prospective, Single-arm Study
This prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. The recombinant human adenovirus type 5 was administered intratumorally on day 1 and 5 in cycle 1 and cycle 2. Lenvatinib was administered orally once daily started on day 1 of cycle 1 .Tislelizumab was administered intravenously every 3 week started on day 1 of cycle 3. The patient accepted the therapy until disease progression or unacceptable toxicity occurred or meet the end point of the study. The primary end point was ORR assessed by investigator using RECIST v1.1 .
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Recombinant Human Adenovirus Type 5, Lenvatinib, Tislelizumab
- 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 5Drug
Also called H101
Recombinant Human Adenovirus Type 5( H101 )was administered intratumorally on day 1 and 5 of cycle 1 and cycle 2. If the sum of the maximum diameters of the lesions was less than or equal to 10 cm, the total dose was 1.0×10^12 vp . If the sum of the maximum diameters of the lesions was more than 10 cm, the total dose was 1.5×10^12 vp. Recombinant Human Adenovirus Type 5 was diluted to 30% of the total tumor volume with normal saline before administration. Under the guidance of ultrasound, percutaneous puncture was performed to the center of the tumor, and the solution was uniformly injected into the tumor. If there are multiple lesions, the distribution of each lesion should be proportional to the size of the tumor. No more than 5 lesions.
LenvatinibDrug
Lenvatinib was administered orally once daily started on day 1 of cycle 1 of the study until disease progression or unacceptable toxicity occurred or meet the end point of the study. For patients weighing less than 60 kg, the recommended daily dose was 8 mg once daily. For patients weighing ≥60 kg, the recommended daily dose was 12 mg once daily
TislelizumabDrug
Tislelizumab 200mg was administered intravenously every 3 week started on day 1 of cycle 3 until disease progression or unacceptable toxicity occurred or meet the end point of the study.
| Study group | Role | What they receive |
|---|---|---|
| intervention arm | Experimental | Not described Receives: Drug: Recombinant Human Adenovirus Type 5; Drug: Lenvatinib; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate using RECIST v1.1
ORR is defined as the proportion of patients who have a partial or complete response to therapy
Measured: 3 years
Secondary outcomes (6)
DOT
Duration of treatment
Measured: 3 years
DOR
Duration of response
Measured: 3 years
DCR
Disease control rate
Measured: 3 years
PFS
progression-free survival
Measured: 3 years
1-year overall survival rate
the overall survival rate at 1 year
Measured: 1years
AE
adverse events base on CTCAE v5.0
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start30 Mar 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06253598
- Sponsor's protocol ID
- HCC-01
- Status last verified
- Feb 2024
- First submitted
- 2 Feb 2024
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Intratumoral Injection of Recombinant Human Adenovirus Type 5 Combined With Tislelizumab and Lenvatinib in the Treatment of Advanced Hepatocellular Carcinoma: a Single-center, Prospective, Single-arm Study
- ClinicalTrials.gov ID
- NCT06253598
- Acronym / sponsor ID
- HCC-01
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 30 Mar 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Feb 2024 (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 prospective, single-arm study was aimed to evaluate the efficacy of recombinant human adenovirus type 5 injection combined with tislelizumab and lenvatinib in the treatment of advanced hepatocellular carcinoma. The recombinant human adenovirus type 5 was administered intratumorally on day 1 and 5 in cycle 1 and cycle 2. Lenvatinib was administered orally once daily started on day 1 of cycle 1 .Tislelizumab was administered intravenously every 3 week started on day 1 of cycle 3. The patient accepted the therapy until disease progression or unacceptable toxicity occurred or meet the end point of the study. The primary end point was ORR assessed by investigator using RECIST v1.1 .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intervention arm | Experimental | Drug: Recombinant Human Adenovirus Type 5, Drug: Lenvatinib, Drug: Tislelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥18 years old, and ≤75 years old, regardless of gender;
- Primary hepatocellular carcinoma confirmed by histology or imaging;
- Patients with advanced hepatocellular carcinoma who have not received oncolytic viruses, immutherapy drugs (including anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs), and systemic therapy (such as anti-VEGF /VEGFR monoclonal antibodies, anti- VEGFR-TKI drugs, chemotherapy);
- ECOG performance status 0-1;
- Child-Pugh score ≤7;
Key exclusion criteria (14 listed)
- Pregnant or lactating women, men or women unwilling to use effective contraception;
- Diffuse liver cancer or tumor is not suitable for RECIST 1.1 criteria;
- Patients who have previously received an oncolytic viral agent such as T-VEC;
- Known allergy to the study drug or its active ingredient, history of allergy to the same biological agent;
- HBV DNA quantitation ≥1000 copies.
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 5Also: H101Recombinant Human Adenovirus Type 5( H101 )was administered intratumorally on day 1 and 5 of cycle 1 and cycle 2. If the sum of the maximum diameters of the lesions was less than or equal to 10 cm, the total dose was 1.0×10^12 vp . If the sum of the maximum diameters of the lesions was more than 10 cm, the total dose was 1.5×10^12 vp. Recombinant Human Adenovirus Type 5 was diluted to 30% of the total tumor volume with normal saline before administration. Under the guidance of ultrasound, percutaneous puncture was performed to the center of the tumor, and the solution was uniformly injected into the tumor. If there are multiple lesions, the distribution of each lesion should be proportional to the size of the tumor. No more than 5 lesions. | Drug | intervention arm |
| LenvatinibLenvatinib was administered orally once daily started on day 1 of cycle 1 of the study until disease progression or unacceptable toxicity occurred or meet the end point of the study. For patients weighing less than 60 kg, the recommended daily dose was 8 mg once daily. For patients weighing ≥60 kg, the recommended daily dose was 12 mg once daily | Drug | intervention arm |
| TislelizumabTislelizumab 200mg was administered intravenously every 3 week started on day 1 of cycle 3 until disease progression or unacceptable toxicity occurred or meet the end point of the study. | Drug | intervention arm |
Primary outcome
Objective response rate using RECIST v1.1
Time frame: 3 years
ORR is defined as the proportion of patients who have a partial or complete response to therapy
6 secondary outcomes
DOT
Time frame: 3 years
DOR
Time frame: 3 years
DCR
Time frame: 3 years
PFS
Time frame: 3 years
1-year overall survival rate
Time frame: 1years
AE
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Adenovirus Type 5, Lenvatinib and Tislelizumab in people with Hepatocellular Carcinoma, run by The First Affiliated Hospital of Bengbu Medical University.
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 12 inclusion and 14 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: opening soon, as of the sponsor's last update on 7 Mar 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wang Zishu, Doctor (+8618909620171, wzshahbb@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate using RECIST v1.1 (time frame: 3 years). 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 7 Mar 2024.