Hepatocellular Carcinoma by BCLC StagePhase 2HESTIANCT05622071
Testing Immunotherapy for Patients With Liver Cancer and Moderately Altered Liver Functions
A Phase 2 study testing Tislelizumab in people with Hepatocellular Carcinoma by BCLC Stage, run by UNICANCER at 10 sites in France.
Trial summary
Liver cancer is the third leading cause of cancer-related deaths worldwide. The majority of primary liver cancers occur as hepatocellular carcinoma (HCC), the incidence of which is increasing in many parts of the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma by BCLC Stage
- What is being tested?
- Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 10 sitesFrance
- Study dates
- 12 Oct 2023to 4 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old
- Patient presenting with histologically-proven Hepatocellular Carcinoma (HCC), or HCC defined by typical imaging findings (EASL criteria), if no biopsy could be performed safely
- Pretreated or not by tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib, regorafenib, cabozantinib)
- Child-Pugh B cirrhosis
- ALBI (Albumin-Bilirubin) grade 1 or 2
- BCLC (Barcelona Clinic Liver Cancer Group) B or C
Show all 23Show fewer
- Availability of biopsy specimen at study enrolment (taken within 3 months of enrolment with the exception of cases where biopsy could not be performed safely)
- ECOG Performance status ≤2
- Adequate organ function as indicated by the following laboratory values:
- Patients must not have required a blood transfusion or growth factor support ≤14 days before sample collection at screening for the following:
- Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L
- Platelets ≥75 x 10⁹/L
- Hemoglobin ≥90 g/L
- Serum creatinine ≤1.5 x upper limit of normal (ULN) or estimated Glomerular Filtration Rate ≥60 mL/min/1.73 m²
- Serum total bilirubin ≤3 mg/dL
- Liver function: ASAT and ALAT ≤5 ULN, albumin >2.0 g/dL
- Presence of measurable and evaluable disease according to RECIST v1.1
- Women of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥120 days after the last dose of tislelizumab, and have a negative urine or serum pregnancy test ≤7 days of first dose of study drug. In case of a urine pregnancy test, it must be a highly sensitive urine pregnancy test
- Non-sterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥120 days after the last dose of tislelizumab. A sterile male is defined as one for whom azoospermia has been previously demonstrated in a semen sample examination as definitive evidence of infertility. Males with known "low sperm counts" (consistent with "sub-fertility") are not to be considered sterile for purposes of this study
- Patients must have provided consent for the study by signing and dating a written informed consent form prior to any study specific procedures, sampling, or analyses. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent
- Patient consent to the use of their collected tumour specimen, as well as blood samples as detailed in the protocol for future scientific research which includes but not limited to DNA, RNA, and proteinbased biomarker detection
- Patient affiliated to a social security regimen
- Men and women patients must consent to not donate or bank sperm or ova during treatment and for 120 days after treatment stop
Who cannot join
- More than 50% of the liver is affected by the HCC (according to investigators evaluation)
- Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Previous treatment with immunotherapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents)
- History of active autoimmune disease. Note: Patients with the following diseases are not excluded and may proceed to further screening:
- Type I diabetes
- Hypothyroidism (provided it is managed with hormone replacement therapy only)
Show all 35Show fewer
- Controlled celiac disease
- Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia)
- Any other disease that is not expected to recur in the absence of external triggering factors
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases
- Any of the following cardiovascular risk factors:
- Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤28 days before first dose of study drug
- Pulmonary embolism ≤28 days before first dose of study drug
- Any history of acute myocardial infarction ≤6 months before first dose of study drug
- Any history of heart failure meeting New York Heart Association (NYHA) Classification III or IV ≤6 months before first dose of study drug
- Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤6 months before first dose of study drug
- Any history of cerebrovascular accident ≤ 6 months before first dose of study drug
- Uncontrolled hypertension: systolic pressure ≥160 mmHg or diastolic pressure ≥100 mmHg despite anti-hypertension medications before first dose of drug
- Any episode of syncope or seizure before first dose of study drug
- Patients with untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers whose HBV DNA is >500 IU/mL or patients with active hepatitis C virus (HCV) should be excluded. Note: Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B (HBV DNA <500 IU/mL), and cured hepatitis C patients can be enrolled
- Known primary immunodeficiency or active HIV
- Immunosuppression, including subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg/day prednisone equivalent) ≤14 days before inclusion. Note: Patients who are currently or have previously been on any of the following steroid regimens are not excluded:
- Adrenal replacement steroid (dose ≤10 mg daily of prednisone or equivalent)
- Topical, ocular, intra-articular, intranasal, or inhaled corticosteroid with minimal systemic absorption
- Short course (≤7 days) of corticosteroid prescribed prophylactically (e.g., for contrast dye allergy) or for the treatment of a non-autoimmune condition (e.g., delayed-type hypersensitivity reaction caused by contact allergen)
- Live vaccine within 4 weeks of first dose of study drug. Note: Seasonal vaccines for influenza are generally inactivated vaccines and Covid vaccination with non-live vaccine are allowed. Intranasal vaccines are live vaccines, and are not allowed
- Transplanted liver, or patient with intent for transplantation
- Received locoregional therapy to the liver (TACE, transcatheter embolization, hepatic arterial infusion, radiation, radioembolization or ablation) in the 4 weeks before inclusion
- Prior malignancy active within the previous 3 years of inclusion except for locally curable cancers considered cured or successfully resected, such as basal or squamous cell skin cancers, superficial bladder cancer, or gastric cancers, or carcinoma in situ of the prostate, cervix, or breast carcinomas. Any oncological concomitant treatment are not allowed during the treatment period
- Has received any herbal medicine used to control cancer with immunostimulant properties that may interfere with liver function within 14 days of the first study drug administration
- Pregnant woman or breast-feeding women or patient with no adequate contraception
- Participation in another therapeutic trial within the 30 days prior to study inclusion
- Patients deprived of their liberty or under protective custody or guardianship
- Patients unable to adhere to the protocol for geographical, social, or psychological reasons
- Patients eligible for treatment by TACE or SIRT are not allowed
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
CHU Angers
Angers
Hôpital Avicenne
Bobigny
CHU Beaujon
Clichy
Hôpital Michallon
Grenoble
CHU La Croix Rousse
Lyon
Hôpital Saint Joseph
Marseille
Institut Paoli Calmette
Marseille
CHU Saint Eloi
Montpellier
Centre Eugene Marquis
Rennes
CHRU Strasbourg
Strasbourg
About this study
Official title: A Multicentric National Phase II Trial Assessing TIslelizumab in Monotherapy for Patients With Hepatocellular Carcinoma Child-Pugh B and ALBI Grade 1 or 2 Liver Function Score
Liver cancer is the third leading cause of cancer-related deaths worldwide. The majority of primary liver cancers occur as hepatocellular carcinoma (HCC), the incidence of which is increasing in many parts of the world. The vast majority of HCC cases occur in the setting of liver cirrhosis, usually due to chronic viral infections with hepatitis C or hepatitis B, alcohol consumption, non-alcoholic fatty liver disease or diabetes. The degree of underlying liver disease, as well as the stage of the tumour and the general condition of the patients, should therefore be taken into account when deciding on the treatment of HCC. Most patients with HCC have advanced disease at the time of diagnosis, or have recurrent disease after potentially curative treatments.
Tislelizumab showed enhanced cellular functional activities by blocking PD-1-mediated reverse signal transduction and activating human T cells and primary peripheral blood mononuclear cells in vitro.
Read more
Based on this preliminary safety profile, and knowing that there is antitumour activity, we can offer tislelizumab as a single agent in patients with unresectable HCC.
HESTIA study is a multicentric French national phase II trial assessing tislelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function score.
It is planned to include 50 patients in the study. All patients will be recruited in France. The study will be presented to eligible patients at participating centres and an information note will be provided. No advertising material is planned for this study.
To be eligible, patients must meet all the following criteria to be ≥18 years old, with histologically proven Hepatocellular Carcinoma (HCC), pre-treated or not with a tyrosine kinase inhibitor and Child-Pugh B cirrhosis, ALBI (Albumin-Bilirubin) grade 1 or 2 and BCLC (Barcelona Clinic Liver Cancer Group) B or C and with no more than 50% liver invasion of tumour disease.
Read the detailed description
The primary objective is to assess efficacy of anti-PD1 (in terms of Objective Response Rate [ORR] based on Best Overall Response across all time-points as defined by RECIST v1.1) in the Child-Pugh B / ALBI grade 1/2 population.
Secondary objectives are :
- To assess safety of anti-PD-1
- To assess efficacy in terms of:
- Objective Response Rate based on best overall response across all time-point according to mRECIST and iRECIST tumor response evaluation
- Overall survival (OS)
- Progression-free survival (PFS)
- Time to progression (TTP)
- To assess Quality of Life according to EORTC QLQ-C30 and HCC-18.
In order to confirm the eligibility of patients, a clinical examination, biological blood tests, ECG, CT scan and a urine or blood pregnancy test for women of childbearing age will be performed. A quality of life questionnaire will be administered to patients. Patients will also be asked to agree to a full eye examination by an ophthalmologist prior to the start of treatment to determine that there is no risk of worsening the patient's visual acuity with treatment with tislelizumab.
After enrolment in the study, the patient will be required to visit the hospital every 3 weeks to receive intravenous treatment for up to 2 years.
Once the treatment is completed, the patient will be seen at follow-up visits for 2 years, initially every 3 months for the first year and then every 6 months for the second year.
Assessment of tumour response by CT or MRI will be done after the start of treatment at weeks 9, 18, 27, 54 and every 12 weeks until disease progression and throughout the treatment period. Tumour assessment by CT or MRI will be performed 2 years after the start of treatment or upon disease progression.
Patients will be asked to consent to the use of a collected tumour sample, as well as to the collection of blood samples, for future scientific research which includes, but is not limited to, the detection of DNA, RNA and protein biomarkers.
An independent Study Monitoring Board (DSMB), with expertise and experience in the pathology, and without direct involvement in the conduct of the study, will be set up specifically to ensure optimal safety monitoring during the early phase of the study and the feasibility of at least 2 treatment injections (6 weeks from inclusion), an early stopping rule has been defined for the first 20 patients included. This method was chosen for the evaluation of serious adverse events (SAEs), which may occur relatively early in this trial. A high frequency of occurrence may necessitate early termination of the trial.
- Conditions
- Hepatocellular Carcinoma by BCLC Stage
- Being tested
- Tislelizumab
- Keywords
- Hepatocellular Carcinoma, tislelizumab, monotherapy, Child-Pugh B, ALBI grade 1 or 2 liver function score
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called BGB-A317
Tislelizumab 200 mg will be administered every 3 weeks IV for a maximum of 2 years
| Study group | Role | What they receive |
|---|---|---|
| SINGLE ARM | Experimental | Tislelizumab 200 mg will be administered every 3 weeks IV. Treatment will be continued until progression or limiting toxicities, for a maximum duration of 2 years and with an average duration of 4 months Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
Objective response rate (ORR) is the percentage of patients with a best response during treatment being either complete response (CR) or partial response (PR).
Measured: 48 months
Secondary outcomes (7)
Frequency of limiting toxicity
Frequency of limiting toxicity is defined as any adverse event related to the experimental drug, and leading to definitive treatment discontinuation according to the investigator, before the second injection.
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Measured: From inclusion, up to 6 months
Frequency of related and not related adverse events
Frequency of all adverse events occurring during the treatment period and until 3 months after treatment discontinuation.
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.
Measured: From inclusion, up to 48 months
Overall survival
The overall survival (OS) is the length of time from randomization that patients enrolled in the study are still alive.
Measured: From inclusion to death from any cause, up to 52 months
Progression-free survival
The progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse.
Measured: From inclusion to disease progression or death, up to 52 months
Time to progression
Time to progression is the length of time patients leave without radiological disease progression.
Measured: From inclusion to radiographic disease progression, up to 52 months
Quality of life questionnaire - Core 30 (QLQ-C30)
Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.
All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: At baseline, every 6 week for 1 year, then every 4 months, up to 52 months
Quality of life questionnaire - Hepatocellular Carcinoma (QLQ-HCC-18)
This EORTC hepatocellular carcinoma specific questionnaire is intended to supplement the QLQ-C30.
The QLQ-HCC18 contains 18 items to assess symptoms hepatocellular-related symptoms. These items are grouped into 6 domains: fatigue, body image, jaundice, nutrition, pain, and fever. Two single items address abdominal swelling and sex life. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale; a higher score represents a more severe symptom or problem.
Measured: At baseline, every 6 week for 1 year, then every 4 months, up to 52 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2022
- Study start12 Oct 2023
- Primary completion15 Jun 2025
- Study completion4 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma by BCLC StageStudies of the same condition, open and under way.
- More trials run by UNICANCERThe 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
- Model description
- Multicentre, national, monotherapy, open-label, phase II single-arm study
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien Edeline, MD PhD, Principal investigator, CLCC UNICANCER EUGENE MARQUIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622071
- Sponsor's protocol ID
- UC-GIG-2003
- Acronym
- HESTIA
- Status last verified
- Sep 2024
- First submitted
- 10 Nov 2022
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Edeline J, Blanc JF. Difficulties for providing evidence in hepatocellular carcinoma with Child-Pugh B liver function. Liver Int. 2023 Feb;43(2):274-275. doi: 10.1111/liv.15495. No abstract available.
PubMed 36680319
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentric National Phase II Trial Assessing TIslelizumab in Monotherapy for Patients With Hepatocellular Carcinoma Child-Pugh B and ALBI Grade 1 or 2 Liver Function Score
- ClinicalTrials.gov ID
- NCT05622071
- Acronym / sponsor ID
- HESTIA / UC-GIG-2003
- Conditions
- Hepatocellular Carcinoma by BCLC Stage
- Keywords
- Hepatocellular Carcinoma, tislelizumab, monotherapy, Child-Pugh B, ALBI grade 1 or 2 liver function score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 15 Jun 2025 (actual)
- Study completion
- 4 Sep 2025 (actual)
- First posted
- 18 Nov 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.
Liver cancer is the third leading cause of cancer-related deaths worldwide. The majority of primary liver cancers occur as hepatocellular carcinoma (HCC), the incidence of which is increasing in many parts of the world. The vast majority of HCC cases occur in the setting of liver cirrhosis, usually due to chronic viral infections with hepatitis C or hepatitis B, alcohol consumption, non-alcoholic fatty liver disease or diabetes. The degree of underlying liver disease, as well as the stage of the tumour and the general condition of the patients, should therefore be taken into account when deciding on the treatment of HCC. Most patients with HCC have advanced disease at the time of diagnosis, or have recurrent disease after potentially curative treatments.
Tislelizumab showed enhanced cellular functional activities by blocking PD-1-mediated reverse signal transduction and activating human T cells and primary peripheral blood mononuclear cells in vitro.
Based on this preliminary safety profile, and knowing that there is antitumour activity, we can offer tislelizumab as a single agent in patients with unresectable HCC.
HESTIA study is a multicentric French national phase II trial assessing tislelizumab in monotherapy for patients with Hepatocellular Carcinoma Child-Pugh B and ALBI grade 1 or 2 liver function score.
It is planned to include 50 patients in the study. All patients will be recruited in France. The study will be presented to eligible patients at participating centres and an information note will be provided. No advertising material is planned for this study.
To be eligible, patients must meet all the following criteria to be ≥18 years old, with histologically proven Hepatocellular Carcinoma (HCC), pre-treated or not with a tyrosine kinase inhibitor and Child-Pugh B cirrhosis, ALBI (Albumin-Bilirubin) grade 1 or 2 and BCLC (Barcelona Clinic Liver Cancer Group) B or C and with no more than 50% liver invasion of tumour disease.
Detailed description
The primary objective is to assess efficacy of anti-PD1 (in terms of Objective Response Rate [ORR] based on Best Overall Response across all time-points as defined by RECIST v1.1) in the Child-Pugh B / ALBI grade 1/2 population.
Secondary objectives are :
- To assess safety of anti-PD-1
- To assess efficacy in terms of:
- Objective Response Rate based on best overall response across all time-point according to mRECIST and iRECIST tumor response evaluation
- Overall survival (OS)
- Progression-free survival (PFS)
- Time to progression (TTP)
- To assess Quality of Life according to EORTC QLQ-C30 and HCC-18.
In order to confirm the eligibility of patients, a clinical examination, biological blood tests, ECG, CT scan and a urine or blood pregnancy test for women of childbearing age will be performed. A quality of life questionnaire will be administered to patients. Patients will also be asked to agree to a full eye examination by an ophthalmologist prior to the start of treatment to determine that there is no risk of worsening the patient's visual acuity with treatment with tislelizumab.
After enrolment in the study, the patient will be required to visit the hospital every 3 weeks to receive intravenous treatment for up to 2 years.
Once the treatment is completed, the patient will be seen at follow-up visits for 2 years, initially every 3 months for the first year and then every 6 months for the second year.
Assessment of tumour response by CT or MRI will be done after the start of treatment at weeks 9, 18, 27, 54 and every 12 weeks until disease progression and throughout the treatment period. Tumour assessment by CT or MRI will be performed 2 years after the start of treatment or upon disease progression.
Patients will be asked to consent to the use of a collected tumour sample, as well as to the collection of blood samples, for future scientific research which includes, but is not limited to, the detection of DNA, RNA and protein biomarkers.
An independent Study Monitoring Board (DSMB), with expertise and experience in the pathology, and without direct involvement in the conduct of the study, will be set up specifically to ensure optimal safety monitoring during the early phase of the study and the feasibility of at least 2 treatment injections (6 weeks from inclusion), an early stopping rule has been defined for the first 20 patients included. This method was chosen for the evaluation of serious adverse events (SAEs), which may occur relatively early in this trial. A high frequency of occurrence may necessitate early termination of the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicentre, national, monotherapy, open-label, phase II single-arm study
| Arm | Type | Receives |
|---|---|---|
| SINGLE ARM | Experimental | Drug: TislelizumabTislelizumab 200 mg will be administered every 3 weeks IV. Treatment will be continued until progression or limiting toxicities, for a maximum duration of 2 years and with an average duration of 4 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age ≥18 years old
- Patient presenting with histologically-proven Hepatocellular Carcinoma (HCC), or HCC defined by typical imaging findings (EASL criteria), if no biopsy could be performed safely
- Pretreated or not by tyrosine kinase inhibitors (e.g., sorafenib, lenvatinib, regorafenib, cabozantinib)
- Child-Pugh B cirrhosis
- ALBI (Albumin-Bilirubin) grade 1 or 2
Key exclusion criteria (35 listed)
- More than 50% of the liver is affected by the HCC (according to investigators evaluation)
- Fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC
- Previous treatment with immunotherapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4 agents)
- History of active autoimmune disease. Note: Patients with the following diseases are not excluded and may proceed to further screening:
- History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases
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 |
|---|---|---|
| TislelizumabAlso: BGB-A317Tislelizumab 200 mg will be administered every 3 weeks IV for a maximum of 2 years | Drug | SINGLE ARM |
Primary outcome
Objective Response Rate
Time frame: 48 months
Objective response rate (ORR) is the percentage of patients with a best response during treatment being either complete response (CR) or partial response (PR).
7 secondary outcomes
Frequency of limiting toxicity
Time frame: From inclusion, up to 6 months
Frequency of related and not related adverse events
Time frame: From inclusion, up to 48 months
Overall survival
Time frame: From inclusion to death from any cause, up to 52 months
Progression-free survival
Time frame: From inclusion to disease progression or death, up to 52 months
Time to progression
Time frame: From inclusion to radiographic disease progression, up to 52 months
Quality of life questionnaire - Core 30 (QLQ-C30)
Time frame: At baseline, every 6 week for 1 year, then every 4 months, up to 52 months
Quality of life questionnaire - Hepatocellular Carcinoma (QLQ-HCC-18)
Time frame: At baseline, every 6 week for 1 year, then every 4 months, up to 52 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 17 Nov 2025.
- Derived from this study: PubMed 36680319Edeline J, Blanc JF. Difficulties for providing evidence in hepatocellular carcinoma with Child-Pugh B liver function. Liver Int. 2023 Feb;43(2):274-275. doi: 10.1111/liv.15495. No abstract available.
- 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.
Julien Edeline, MD PhD principal investigator
CLCC UNICANCER EUGENE MARQUIS
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Hepatocellular Carcinoma by BCLC Stage, run by UNICANCER at 10 sites in France.
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 23 inclusion and 35 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 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. 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?
Objective Response Rate (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05622071, which also lists 1 linked publication.
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 17 Nov 2025.