Hepatocellular CarcinomaPhase 2NCT05471674
Neoadjuvant Anti-PD1 in HCC
A Phase 2 study testing Nivolumab and Hepatectomy in people with Hepatocellular Carcinoma and HCC, run by Dr Tan-to CHEUNG at 1 site in Hong Kong.
Trial summary
This is a phase 2, single-arm trial designed to assess the clinical benefit of treatment with nivolumab administered in patients with untreated, borderline resectable HCC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, HCC, Liver Cancer
- What is being tested?
- Nivolumab and Hepatectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jul 2020to 31 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed written informed consent form prior to the screening procedures.
- Age ≥ 18 years.
- Histological proof of HCC.
- Willingness to undergo a pre-dosing fresh tumour biopsy. Patients for whom fresh biopsy may not be feasible will be ineligible for enrollment.
- Intermediate or locally-advanced HCC (according to HKLC tumour status categorization) with the option of resection for potential cure as assessed by surgeon.
- Child-Pugh score ≤ 7 with no symptomatic ascites or ascites requiring therapeutic paracentesis.
Show all 13Show fewer
- ECOG performance status ≤ 1.
- Life expectancy of ≥ 12 weeks.
- Adequate organ function (blood transfusion or use of biologic response modifiers is not permitted).
- Measurable disease according to RECIST v1.1.
- Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception.
- Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception.
- Able and willing to meet all protocol-required treatments, investigations and visits.
Who cannot join
- Patients who have history of organ transplantation.
- History of allergy or hypersensitivity to study drug components.
- Patients who have active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition adequately treated with hormonal replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger or deemed by the investigator not to affect safety assessment.
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-regulatory pathways).
- Receipt of any cancer therapy in the pre-operative period.
Show all 15Show fewer
- Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicine) intended for general health support or to treat the disease under study within 2 weeks prior to treatment.
- Active, acute, or chronic clinically significant infections requiring therapy with the exception of hepatitis B or C virus infection. Patients with chronic HBV infection must be on antiviral therapy and have HBV DNA < 500 IU/ml. Active or chronic co-infection with hepatitis B and C, or hepatitis B and D is not allowed.
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Symptomatic congestive heart failure, defined as ≥ Class II of the New York Heart Association functional classification system or known LVEF < 50% at baseline.
- Active angina pectoris or recent myocardial infarction (within 6 months).
- Chronic atrial fibrillation or QTcF > 470 msec.
- History of other previous cancer that would interfere with the determination of safety or efficacy of nivolumab with respect to HCC.
- Women who are pregnant or breast-feeding.
- Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of study results.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neoadjuvant Immunotherapy With Anti-PD1 in Borderline Resectable Hepatocellular Carcinoma
This is a phase 2, single-arm trial designed to assess the clinical benefit of treatment with nivolumab administered in patients with untreated, borderline resectable HCC.
- Conditions
- Hepatocellular Carcinoma, HCC, Liver Cancer
- Being tested
- Nivolumab, Hepatectomy
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
3 mg/kg on Day 1 of each 2-weekly cycle for 3 doses
HepatectomyProcedure or surgery
Hepatectomy will be performed approximately 2 weeks after the 3rd dose of nivolumab
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Drug: Nivolumab; Procedure: Hepatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological tumour response rate
Proportion of patients with resected tumours having ≥30% necrosis
Measured: After surgery (normally 6 weeks after the start of nivolumab)
Secondary outcomes (4)
Recurrence-free survival
The time from resection to disease recurrence or death from any cause
Measured: At least 3 months after surgery
Overall survival
The time from start of treatment to the date of death from any cause or last follow-up date
Measured: At least 3 months after surgery
Short-term surgery outcomes
Operation time, blood loss during surgery, transfusion requirement during surgery, and complication rate within 2 weeks following surgery
Measured: 2 weeks after surgery
Safety and tolerability of nivolumab
The incidence, severity as graded by NCI CTCAE v5.0, seriousness and relationship to study medication of adverse events (AEs)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start3 Jul 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Tan-to CHEUNG
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr Tan-to CHEUNG, The University of Hong Kong
- Investigators
- Tan-to Cheung, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05471674
- Sponsor's protocol ID
- CA209-7KU
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2022
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Immunotherapy With Anti-PD1 in Borderline Resectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05471674
- Acronym / sponsor ID
- CA209-7KU
- Conditions
- Hepatocellular Carcinoma, HCC, Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Dr Tan-to CHEUNGUniversity, hospital or other
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 25 Jul 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.
This is a phase 2, single-arm trial designed to assess the clinical benefit of treatment with nivolumab administered in patients with untreated, borderline resectable HCC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Nivolumab, Procedure: Hepatectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed written informed consent form prior to the screening procedures.
- Age ≥ 18 years.
- Histological proof of HCC.
- Willingness to undergo a pre-dosing fresh tumour biopsy. Patients for whom fresh biopsy may not be feasible will be ineligible for enrollment.
- Intermediate or locally-advanced HCC (according to HKLC tumour status categorization) with the option of resection for potential cure as assessed by surgeon.
Key exclusion criteria (15 listed)
- Patients who have history of organ transplantation.
- History of allergy or hypersensitivity to study drug components.
- Patients who have active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition adequately treated with hormonal replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger or deemed by the investigator not to affect safety assessment.
- Patients with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-regulatory pathways).
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 |
|---|---|---|
| Nivolumab3 mg/kg on Day 1 of each 2-weekly cycle for 3 doses | Drug | Treatment |
| HepatectomyHepatectomy will be performed approximately 2 weeks after the 3rd dose of nivolumab | Procedure or surgery | Treatment |
Primary outcome
Pathological tumour response rate
Time frame: After surgery (normally 6 weeks after the start of nivolumab)
Proportion of patients with resected tumours having ≥30% necrosis
4 secondary outcomes
Recurrence-free survival
Time frame: At least 3 months after surgery
Overall survival
Time frame: At least 3 months after surgery
Short-term surgery outcomes
Time frame: 2 weeks after surgery
Safety and tolerability of nivolumab
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- HKU Clinical Trials Registry recordLink provided by the sponsor.
Related trials for Hepatocellular Carcinoma
RecruitingPhase 2
DB-1311 in Combination With BNT327 or DB-1305 in Advanced/Metastatic Solid Tumors
Solid Tumors
RecruitingPhase 2
18F-Fibroblast Activation Protein Inhibitor ([18F]FAPI-74) PET Imaging for Cancer Detection
Sarcoma, Small Cell Lung Cancer or Extrapulmonary Neuroendocrine Cancer (EP-NEC)
Not yet recruitingPhase 3
A Study of TACE in Combination With SHR-8068, Adebrelimab, and Bevacizumab Versus TACE in Participants With Incurable Hepatocellular Carcinoma
Hepatocellular Carcinoma
Not yet recruitingObservational study
Immune-Related Adverse Events and Clinical Outcomes of First-Line Immunotherapy in Egyptian Patients With Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma, Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 2
An Exploratory Study of Single-Dose Neoadjuvant Nivolumab Without Surgical Delay in Patients With Resectable HCC
Hepato Cellular Carcinoma (HCC), Immune Checkpoint Inhibitor
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.
Tan-to Cheung, MD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Hepatectomy in people with Hepatocellular Carcinoma and HCC, run by Dr Tan-to CHEUNG at 1 site in Hong Kong.
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 15 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: finished, as of the sponsor's last update on 1 Feb 2023. 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 Hong Kong. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological tumour response rate (time frame: After surgery (normally 6 weeks after the start of nivolumab)). 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 1 Feb 2023.