Hepatocellular CarcinomaPhase 1NCT05281926
A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients
A Phase 1 study testing Poly ICLC in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Hepatocellular carcinoma (HCC) is a prevalent malignancy with great disease burden both in Taiwan and worldwide 1. Early stage HCC can be treated by surgical resection, radiofrequency ablation, embolization and liver transplantation. However, treatments for advanced HCC are still unsatisfactory. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Poly ICLC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2021to 30 Sep 2024
- Phase
- Phase 1
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of hepatocellular carcinoma.
- Must be 20 years of age or older.
- Unresectable disease. Patients with resectable HCC but who refuse surgery may be enrolled after a documented consultation with a surgeon.
- Radiologically measurable disease that is at least 2 cm in longest dimension of the target tumor.
- ECOG performance status of ≤ 2.
- Child-Pugh classification A.
Show all 13Show fewer
- Patients with chronic hepatitis B must be under long-term anti-viral agents with a high barrier of resistance, such as Entecavir, Tenofovir Disoproxil Fumarate, or Tenofovir Alafenamide.
- Patients with chronic hepatitis C must reach sustained viral response by the treatment with any direct acting agent.
- Acceptable hematologic, renal and liver function as follows within 28 days before entering the trial:
- (A)Absolute neutrophil count ≥ 1500/mm3 (B)Platelets ≥ 80,000/mm3 (C)Hemoglobin > 10.0 g/dL (D)Creatinine ≤ 2.0 mg/dl (E)Total bilirubin ≤ 1.5 mg/dl, unless due to Gilbert's syndrome (F)Transaminases (AST and ALT) ≤ 2 times above the upper limits (G)INR < 1.5
- Patients must be able to provide informed consent.
- Willing and able to comply with scheduled visits, treatment plan and laboratory tests.
- Patients with the potential for pregnancy or impregnating their partner must agree to follow acceptable birth control methods to avoid conception. Contraception must be continued for at least 5 months following the last dose of Nivolumab. Women of childbearing potential must have a negative pregnancy test. Women who have been menopausal for more than 1 year (more than 12 months since their last menstrual period) or patients who have undergone sterilization are not required to undergo pregnancy testing.
Who cannot join
- Patients may not be receiving any other investigational agents, biological agents or other anti-cancer medication.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Based on its mechanism of action and data from animal studies, Nivolumab can cause fetal harm when administered to a pregnant woman. Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
- Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
- HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with <200 CD4+ T cells/microliter in the peripheral blood.
Show all 10Show fewer
- History of allogeneic hematopoietic cell transplantation or solid organ transplantation.
- Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps)
- The target tumor is blocked by the bile duct or important blood vessel that leads to difficulty in intratumor injection.
- Principal investigator believes that for one or multiple reasons the patient will be unable to comply with all study visits, or if they believe the trial is not clinically in the best interest of the patient.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
NTUH
Taipei, Zhongzheng Dist, 100
Tzu Meng Weng, +8862312-3456 ext. 66579, wengmengtzu@gmail.com
About this study
Hepatocellular carcinoma (HCC) is a prevalent malignancy with great disease burden both in Taiwan and worldwide 1. Early stage HCC can be treated by surgical resection, radiofrequency ablation, embolization and liver transplantation. However, treatments for advanced HCC are still unsatisfactory. Systemic therapy is necessary for advanced HCC 2. Target therapy using sorafenib was established a decade ago, but its response rate is quite low (~3%), the adverse effects may be intolerable and it can only extend survival 2.3 to 2.8 months 3,4. Newly developed tyrosine kinase inhibitors (TKIs) include regorafenib 5, lenvatinib 6, cabozantinib 7 and ramucirumab 8. The single target therapy objective response rate is around 3-24%. Recently, immune checkpoint inhibitors (ICIs) emerged as a new hope for cancer therapy in various kinds of malignancies including HCC. These include CTLA4, PD-1 and PD-L1 blockades.
Read the detailed description
This is an open-label, phase I pilot study. A total of 10 patients will be recruited in National Taiwan University Hospital between October, 01, 2021 and December, 31 2023. All examinations and treatment will be performed at National Taiwan University Hospital. The inclusion criteria are Child-Pugh classification A, unresectable HCC patients with age more than 20 years-old and radiologically measurable disease that is at least 2 cm in longest dimension of the target tumor.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Poly ICLC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poly ICLCDrug
Also called Nivolumab
IT Poly-ICLC injection (1.0 mg) at Day 1 of weeks 0, 1 and 2. IM Poly-ICLC (20 μg/Kg) at Day 1 and Day 3 of weeks 3, 4, 5 and 6.
| Study group | Role | What they receive |
|---|---|---|
| Poly-ICLC | Experimental | Hiltonol is a poly-ICLC developed by the Oncovir, Inc. A phase I study of hiltonol monotherapy in solid tumors was completed (NCT01984892). Clinical trials of hiltonol plus ICIs are undergone in various type cancers (NCT03721679, NCT02834052). Receives: Drug: Poly ICLC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration-Time Curve(ACU 0-22 weeks)
Measured: prior to the initial dose on day 1 and Day 3 of weeks 10, 14, 18 and 22.
Secondary outcomes (1)
Area Under the Concentration-Time Curve(ACU 0-24 weeks)
Measured: prior to the initial dose on day 2 of weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start1 Oct 2021
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Sep 2024 (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.
- More trials run by National Taiwan University 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05281926
- Sponsor's protocol ID
- 202104104MIND
- Status last verified
- Jun 2021
- First submitted
- 7 Mar 2022
- Last updated
- 16 Mar 2022
- 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 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label Study to Assess the Safety and Efficacy of Poly-ICLC Plus Nivolumab in Unresectable Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT05281926
- Acronym / sponsor ID
- 202104104MIND
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Sep 2024 (estimated)
- First posted
- 16 Mar 2022 (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.
Hepatocellular carcinoma (HCC) is a prevalent malignancy with great disease burden both in Taiwan and worldwide 1. Early stage HCC can be treated by surgical resection, radiofrequency ablation, embolization and liver transplantation. However, treatments for advanced HCC are still unsatisfactory. Systemic therapy is necessary for advanced HCC 2. Target therapy using sorafenib was established a decade ago, but its response rate is quite low (~3%), the adverse effects may be intolerable and it can only extend survival 2.3 to 2.8 months 3,4. Newly developed tyrosine kinase inhibitors (TKIs) include regorafenib 5, lenvatinib 6, cabozantinib 7 and ramucirumab 8. The single target therapy objective response rate is around 3-24%. Recently, immune checkpoint inhibitors (ICIs) emerged as a new hope for cancer therapy in various kinds of malignancies including HCC. These include CTLA4, PD-1 and PD-L1 blockades.
Detailed description
This is an open-label, phase I pilot study. A total of 10 patients will be recruited in National Taiwan University Hospital between October, 01, 2021 and December, 31 2023. All examinations and treatment will be performed at National Taiwan University Hospital. The inclusion criteria are Child-Pugh classification A, unresectable HCC patients with age more than 20 years-old and radiologically measurable disease that is at least 2 cm in longest dimension of the target tumor.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Poly-ICLC | Experimental | Drug: Poly ICLCHiltonol is a poly-ICLC developed by the Oncovir, Inc. A phase I study of hiltonol monotherapy in solid tumors was completed (NCT01984892). Clinical trials of hiltonol plus ICIs are undergone in various type cancers (NCT03721679, NCT02834052). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Histologically confirmed diagnosis of hepatocellular carcinoma.
- Must be 20 years of age or older.
- Unresectable disease. Patients with resectable HCC but who refuse surgery may be enrolled after a documented consultation with a surgeon.
- Radiologically measurable disease that is at least 2 cm in longest dimension of the target tumor.
- ECOG performance status of ≤ 2.
Key exclusion criteria (10 listed)
- Patients may not be receiving any other investigational agents, biological agents or other anti-cancer medication.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection requiring antibiotics (exception is a brief (≤10days) course of antibiotics to be completed before initiation of treatment), symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements.
- Based on its mechanism of action and data from animal studies, Nivolumab can cause fetal harm when administered to a pregnant woman. Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
- Has a diagnosis of primary immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.
- Has active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.
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 |
|---|---|---|
| Poly ICLCAlso: NivolumabIT Poly-ICLC injection (1.0 mg) at Day 1 of weeks 0, 1 and 2. IM Poly-ICLC (20 μg/Kg) at Day 1 and Day 3 of weeks 3, 4, 5 and 6. | Drug | Poly-ICLC |
Primary outcome
Area Under the Concentration-Time Curve(ACU 0-22 weeks)
Time frame: prior to the initial dose on day 1 and Day 3 of weeks 10, 14, 18 and 22.
1 secondary outcome
Area Under the Concentration-Time Curve(ACU 0-24 weeks)
Time frame: prior to the initial dose on day 2 of weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 and 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
RecruitingPhase 2/3
A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
HCC
Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
Hepatocellular Carcinoma
RecruitingPhase 1
A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
Liver Cancer (Fibrolamellar Hepatocellular Cancer (FLC))
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Poly ICLC in people with Hepatocellular Carcinoma, run by National Taiwan University Hospital at 1 site in Taiwan.
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 13 inclusion and 10 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 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Tzu Meng Weng (+886-2312-3456 ext. 66579, wengmengtzu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area Under the Concentration-Time Curve(ACU 0-22 weeks) (time frame: prior to the initial dose on day 1 and Day 3 of weeks 10, 14, 18 and 22.). 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 16 Mar 2022.