Hepatocellular Carcinoma Non-resectablePhase 2IOSPHERENCT07122089
Evaluation of SIRT Followed by Immunotherapy for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis
A Phase 2 study testing Selective Internal Radiotherapy, Tremelimumab and Durvalumab in people with Hepatocellular Carcinoma Non-resectable, run by Center Eugene Marquis at 6 sites in France.
Trial summary
Hepatocellular carcinoma (HCC) is the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma Non-resectable
- What is being tested?
- Selective Internal Radiotherapy, Tremelimumab and Durvalumab
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesFrance
- Study dates
- 25 Feb 2026to 2 Jan 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18,
- ECOG Performance Status 0-1,
- Histologically proven HCC or noninvasive HCC diagnosis according to LiRADS criteria,
- HCC with Portal vein involvement (PVT), segmental, sectorial or lobar, evaluated by diagnostic imaging (CT scan or MRI),
- At least one measurable lesion≥ 10mm using mRECIST criteria evaluated by diagnostic imaging,
- Tumor involvement <50% of the liver,
Show all 11Show fewer
- Hepatic reserve after SIRT ≥ 30% (i.e. hepatic parenchyma not treated with SIRT) evaluated by diagnostic imaging
- No cirrhosis or Compensated cirrhosis (Child Pugh A, ALBI score 1 or 2),
- SIRT indication confirmed by a multidisciplinary team meeting (i.e. patient not a candidate for liver resection, thermal ablation, or transplantation at the time of study),
- Registration with a social security scheme,
- Written and informed consent of the patient.
Who cannot join
- Patient with main PVT (partial or complete),
- Extrahepatic metastases (patients with EHS), except hilum node < 2 cm,
- Previous episode of ascites and/or presence of ascites, even if only seen on imaging without clinical detection (except minimum blade only peri-hepatic),
- Previous episode of hepatic encephalopathy and/or hepatic encephalopathy presence at study entry and/or episodes of encephalopathy (Grade ≥2) within 6 months prior to study inclusion,
- Pulmonary insufficiency (defined by an arterial oxygen pressure (PaO2) of <60 mmHg, or oxygen saturation (SaO2) of <90% (Roussos \& Koutsoukou, 2003) or clinically evident chronic obstructive pulmonary disease (COPD),
- Medical history of radiation pneumonitis or recent pneumonitis, regardless of causality,
Show all 63Show fewer
- Previous HCC therapies:
- Any prior systemic treatment for HCC;
- More than 2 prior TACE (or embolization), in the area to be treated;
- Liver resection or ablation <6 months from end of previous treatment to TheraSphere administration;
- Liver ablation <3 months from end of previous treatment to TheraSphere administration.
- Prior exposure to immune mediated therapy for HCC or other disease, such as other anti-PD-1, anti-PDL-1, anti-PDL-2, anti-CTLA-4, antibodies, etc.
- Previous liver radiation (external beam radiation therapy (EBRT) or peptide receptor radionuclide therapy (PRRT) or SIRT
- Inadequate hematological, hepatic and renal functions:
- Hemoglobin <8,5 g/dl;
- Granulocytes <1500/mm3;
- Platelets < 50 000 /mm3;
- Bilirubin level ≥35 umol/l;
- Albumin <28g/L;
- Transaminases > 5 UNL;
- Creatinine > 1,5 UNL;
- INR>2 (or TP <60%) without anti-coagulation.
- Any contraindication to angiography or selective visceral catheterization,
- History of any organ allograft, including bone marrow allo and autograft,
- History of active primary/acquired immunodeficiency, that makes patients unsuitable for additional immunotherapy in this study (per investigator),
- Active or prior documented autoimmune or inflammatory disorders (including but not limited to inflammatory bowel disease [e.g. ulcerative colitis or Crohn's disease], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis]). The following are exceptions to this criterion:
- Patients with vitiligo or alopecia;
- Patients with hypothyroidism (e.g. following Hashimoto's syndrome) stable on hormone replacement therapy;
- Any chronic skin condition that does not require systemic therapy;
- Patients with celiac disease controlled by diet alone.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g. intra-articular injection),
- In the case of background systemic corticosteroid use, doses of prednisone or its equivalent >10 mg/day,
- Need for premedication of hypersensitivity reactions with Steroids (e.g. CT scan premedication),
- History of gastrointestinal bleeding within 42 days prior to study inclusion, active GI bleeding and any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device). Patients with known varices that have not bled or which have been clinically addressed can enter the study. No endoscopic exploration is required before study inclusion,
- Presence of biliary stent or sphincterotomy within one year prior to study inclusion,
- History of malignancy, other than HCC, within two years, except the condition is one of the following:
- Adequately treated carcinoma in situ of the cervix, early squamous cell carcinoma or basal cell carcinoma of the skin, localized prostate cancer, breast ductal carcinoma in situ, or low-grade endometrial carcinoma with no myometrial invasion;
- Localized prostate cancer under active surveillance;
- Other cancer when there is a negligible risk of recurrence or progression or death (5-year OS rate > 90%).
- Major surgical procedure (as defined by the Investigator) within 42 days prior to study inclusion,
- A history of severe allergy or intolerance to contrast agents, narcotics, sedatives, or atropine that cannot be managed medically,
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients that cannot be managed medically,
- Active infection, including:
- Tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice),
- HBV* and Hep D co-infection,
- Human immunodeficiency virus** (HIV 1/2 antibodies) plus HCV or HBV* co-infection.
- Patients with active HBV infection or HCV infection must be managed according to local standard of care. Patients must show evidence of viral disease stabilization prior to inclusion.
- Patients with Human Immunodeficiency Virus (HIV) infection are eligible, provided the HIV infection is well controlled with no current or previous AIDS-related complications and CD4+ T-cell (CD4+) counts ≥ 350 cells/µL
- Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab and/or tremelimumab. Note: patients, if enrolled, should not receive live vaccine whilst receiving durvalumab and/or tremelimumab and up to 30 days after the last dose of durvalumab and/or tremelimumab,
- Participation in another clinical trial in the 4 weeks prior to enrollment, unless it is an observational study or a 4-week no-treatment follow-up phase of an interventional study,
- Female patients who are pregnant (a negative serum pregnancy test is mandatory for inclusion) or breastfeeding and who do not want to stop breastfeeding. Male or female patients of reproductive potential who are not willing to employ any effective birth control method from screening and for at least 3 months post the last dose of study treatment (durvalumab ± tremelimumab and/or TheraSphere), whichever is later,
- Unstable chronic disease or evidence of any disease or condition that would place the patient at undue risk and preclude safe use of TheraSphere, durvalumab and tremelimumab treatment as deemed by the site principal investigator,
- Patients who are not able to follow the TheraSphere, durvalumab or tremelimumab treatment requirements,
- Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care under articles L. 3212-1 and L. 3213-1 who are not covered by the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research, including:
- Persons receiving psychiatric treatment;
- Persons admitted to a health or social establishment for purposes other than research;
- Person of full age under curatorship;
- Adult subject to a mandate for future protection, a family authorization, or a guardianship measure.
- Angiograhy and dosimetry exclusion criteria:
- Cone Beam CT (CBCT) or Technetium-99m Macro Aggregated Albumin (99mTc-MAA) hepatic arterial perfusion scintigraphy shows any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques,
- 99mTc-MAA hepatic arterial perfusion scintigraphy shows poor tumor targeting and/or a poor portal vein thrombosis (PVT) targeting (99mTc-MAA uptake ≤ normal liver uptake),
- The dosimetry endpoints cannot be reached (refer to the supplement A "TheraSphere Treatment Planning, Dosimetry Guidance document"),
- Shunting of blood to the lungs that could result in delivery of >30 Gy to the lungs in a single treatment, or >50 Gy cumulative dose to the lungs in case of multiple TheraSphere treatments, as seen on 99mTc-MAA hepatic arterial perfusion scintigraphy.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 2 recruiting
- Active, not recruiting
CHU de Grenoble
Grenoble
- Active, not recruiting
CHU de Lille
Lille
- Not yet recruiting
La Timone
Marseille
Prof GEROLAMI, 04 91 38 00 32, rene.gerolami@ap.hm.fr
- Active, not recruiting
CHU de Montpellier
Montpellier
- Active, not recruiting
CHU de Nice
Nice
- Recruiting
Centre Eugène Marquis
Rennes
Garin Etienne Professeur, 0299253075, e.garin@rennes.unicancer.fr
About this study
Official title: A Multicenter Open-label, Prospective Study to Evaluate the Efficacy and Safety of SIRT Using Yttrium-90 Glass Microspheres Followed by Durvalumab and Tremelimumab for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis
Hepatocellular carcinoma (HCC) is the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually.
For advanced patients, including patients with tumoral portal vein thrombosis (PVT), most treatment guidelines recommend systemic therapy, either combination immunotherapy (IO) or combination of immunotherapy and anti-angiogenic treatment for first line option.
Read more
Results for PVT patients are provided in one trial with a median overall survival of 14.2 months with IO underlying the necessity to improve treatment of PVT patients. Two recent other phase 3 trials also reported positive results for different IO regimen.
Selective internal radiation therapy (SIRT) using yttrium-90 (90Y)-loaded glass microspheres (TheraSphereTM) can be used for patients with early stage to locally advanced HCC including PVT patients without extrahepatic spread (EHS). TheraSphereTM is recognized and is reimbursed in France for PVT patients without EHS, since 2019.Several retrospective studies have shown promising results for PVT patients.
Nowadays use of SIRT in locally advanced HCC is regaining interest based on the results of the randomized DOSISPHERE-01 study including non-operable patients, about 70% with PVT. This randomized Phase II trial using 90Y-loaded microspheres sought was noted the effectiveness of 90Y-loaded microspheres using a personalized dosimetry approach versus a standard dosimetry approach.
The use of a systemic treatment as IO after a locoregional treatment with the strong local debulking effect of SIRT is logical and of interest. Indeed, the most frequent pattern of progression after SIRT is recurrence in an untreated area, including untreated liver or EHS. Patients are then usually referred to IO.
Such kind of therapeutic approach, using SIRT followed by IO has already been evaluated in a phase 2 study using nivolumab after 90Y loaded resin microspheres with promising efficacy without safety deterioration.
The aim of this study is to evaluate SIRT followed by IO used according to their current indications in advanced HCC patient with PVT patients and without EHS.
Read the detailed description
The study plans to included 80 patients and to treated 72 patients (take into account screen failures and SIRT contraindications).
First, patient will receive SIRT using Yttrium-90 glass microspheres. Immunotherapy with an injection of Tremelimumab followed by Durvalumab must be started 1 to 3 weeks after SIRT.
Durvalumab monotherapy is continued every 4 weeks until disease progression, or toxicity leading to definitive treatment discontinuation, or loss of clinical benefit, or investigator decision, or lost for follow-up or death patient.
Patients are followed prior to the occurrence of progressive disease, within a maximum 18-month period after the initiation IO.
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Being tested
- Selective Internal Radiotherapy, Tremelimumab, Durvalumab
- Keywords
- Hepatocellular carcinoma, Immunotherapy, Selective internal radiation therapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective Internal RadiotherapyDevice
Also called SIRT
SIRT will use Yttrium-90 glass-microspheres (TheraSphereTM). SIRT needs two steps: the treatment simulation (diagnostic angiography and scintigraphy of hepatic perfusion with 99mTc-MAA) and the administration (during a therapeutic angiography).
TremelimumabDrug
Also called IMJUDO®
Tremelimumab should be done 1 to 3 weeks after SIRT and is administrated according to the Summary of Product Characteristic (SPC).
DurvalumabDrug
Also called Imfinzi®
After the end of the tremelimumab infusion, patient receive durvalumab then one injection every 4 weeks until further progression upon investigator decision. Also administrated according to the Summary of Product Characteristic (SPC).
| Study group | Role | What they receive |
|---|---|---|
| Hepatocellular carcinoma with portal vein thrombosis and without hepatic spread | Experimental | Patient will receive selective internal radiation therapy and immunotherapy as per standard of care.
SIRT Administration is direct intra-arterial injection in the hepatic artery to target only liver disease and IO will be performed as describe below:
* Tremelimumab (Imjudo®): 300 mg IV, one-hour infusion;
* Durvalumab (Imfinzi®): 1500 mg IV, one-hour infusion every 4 weeks. Receives: Device: Selective Internal Radiotherapy; Drug: Tremelimumab; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
The Objective Response Rate (ORR) is defined as the proportion of patients who have either a Partial Response (PR) or a Complete Response (CR) to treatment. CR and PR are the best overall response across all time points of tumor evaluation. Overall tumor response at each time point is assessed according to the modified RECIST criteria for HCC.
Measured: Through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start25 Feb 2026
- Primary completion2 Jan 2030 (estimated)
- Study completion2 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma Non-resectableStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Etienne Garin, MD PHD, Principal investigator, Centre de Lutte Contre Le cancer Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122089
- Sponsor's protocol ID
- 2025-3-77-001
- Other IDs
- 2025-A01081-48
- Acronym
- IOSPHERE
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2025
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Open-label, Prospective Study to Evaluate the Efficacy and Safety of SIRT Using Yttrium-90 Glass Microspheres Followed by Durvalumab and Tremelimumab for Treatment of Hepatocellular Carcinoma With Portal Vein Thrombosis
- ClinicalTrials.gov ID
- NCT07122089
- Acronym / sponsor ID
- IOSPHERE / 2025-3-77-001
- Conditions
- Hepatocellular Carcinoma Non-resectable
- Keywords
- Hepatocellular carcinoma, Immunotherapy, Selective internal radiation therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- 2 Jan 2030 (estimated)
- Study completion
- 2 Jan 2030 (estimated)
- First posted
- 14 Aug 2025 (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 the most common primary liver cancer, being the third leading cause of cancer-related death worldwide, with approximately 745 000 deaths reported annually.
For advanced patients, including patients with tumoral portal vein thrombosis (PVT), most treatment guidelines recommend systemic therapy, either combination immunotherapy (IO) or combination of immunotherapy and anti-angiogenic treatment for first line option.
Results for PVT patients are provided in one trial with a median overall survival of 14.2 months with IO underlying the necessity to improve treatment of PVT patients. Two recent other phase 3 trials also reported positive results for different IO regimen.
Selective internal radiation therapy (SIRT) using yttrium-90 (90Y)-loaded glass microspheres (TheraSphereTM) can be used for patients with early stage to locally advanced HCC including PVT patients without extrahepatic spread (EHS). TheraSphereTM is recognized and is reimbursed in France for PVT patients without EHS, since 2019.Several retrospective studies have shown promising results for PVT patients.
Nowadays use of SIRT in locally advanced HCC is regaining interest based on the results of the randomized DOSISPHERE-01 study including non-operable patients, about 70% with PVT. This randomized Phase II trial using 90Y-loaded microspheres sought was noted the effectiveness of 90Y-loaded microspheres using a personalized dosimetry approach versus a standard dosimetry approach.
The use of a systemic treatment as IO after a locoregional treatment with the strong local debulking effect of SIRT is logical and of interest. Indeed, the most frequent pattern of progression after SIRT is recurrence in an untreated area, including untreated liver or EHS. Patients are then usually referred to IO.
Such kind of therapeutic approach, using SIRT followed by IO has already been evaluated in a phase 2 study using nivolumab after 90Y loaded resin microspheres with promising efficacy without safety deterioration.
The aim of this study is to evaluate SIRT followed by IO used according to their current indications in advanced HCC patient with PVT patients and without EHS.
Detailed description
The study plans to included 80 patients and to treated 72 patients (take into account screen failures and SIRT contraindications).
First, patient will receive SIRT using Yttrium-90 glass microspheres. Immunotherapy with an injection of Tremelimumab followed by Durvalumab must be started 1 to 3 weeks after SIRT.
Durvalumab monotherapy is continued every 4 weeks until disease progression, or toxicity leading to definitive treatment discontinuation, or loss of clinical benefit, or investigator decision, or lost for follow-up or death patient.
Patients are followed prior to the occurrence of progressive disease, within a maximum 18-month period after the initiation IO.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatocellular carcinoma with portal vein thrombosis and without hepatic spread | Experimental | Device: Selective Internal Radiotherapy, Drug: Tremelimumab, Drug: DurvalumabPatient will receive selective internal radiation therapy and immunotherapy as per standard of care. SIRT Administration is direct intra-arterial injection in the hepatic artery to target only liver disease and IO will be performed as describe below: * Tremelimumab (Imjudo®): 300 mg IV, one-hour infusion; * Durvalumab (Imfinzi®): 1500 mg IV, one-hour infusion every 4 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18,
- ECOG Performance Status 0-1,
- Histologically proven HCC or noninvasive HCC diagnosis according to LiRADS criteria,
- HCC with Portal vein involvement (PVT), segmental, sectorial or lobar, evaluated by diagnostic imaging (CT scan or MRI),
- At least one measurable lesion≥ 10mm using mRECIST criteria evaluated by diagnostic imaging,
Key exclusion criteria (63 listed)
- Patient with main PVT (partial or complete),
- Extrahepatic metastases (patients with EHS), except hilum node < 2 cm,
- Previous episode of ascites and/or presence of ascites, even if only seen on imaging without clinical detection (except minimum blade only peri-hepatic),
- Previous episode of hepatic encephalopathy and/or hepatic encephalopathy presence at study entry and/or episodes of encephalopathy (Grade ≥2) within 6 months prior to study inclusion,
- Pulmonary insufficiency (defined by an arterial oxygen pressure (PaO2) of <60 mmHg, or oxygen saturation (SaO2) of <90% (Roussos \& Koutsoukou, 2003) or clinically evident chronic obstructive pulmonary disease (COPD),
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 |
|---|---|---|
| Selective Internal RadiotherapyAlso: SIRTSIRT will use Yttrium-90 glass-microspheres (TheraSphereTM). SIRT needs two steps: the treatment simulation (diagnostic angiography and scintigraphy of hepatic perfusion with 99mTc-MAA) and the administration (during a therapeutic angiography). | Device | Hepatocellular carcinoma with portal vein thrombosis and without hepatic spread |
| TremelimumabAlso: IMJUDO®Tremelimumab should be done 1 to 3 weeks after SIRT and is administrated according to the Summary of Product Characteristic (SPC). | Drug | Hepatocellular carcinoma with portal vein thrombosis and without hepatic spread |
| DurvalumabAlso: Imfinzi®After the end of the tremelimumab infusion, patient receive durvalumab then one injection every 4 weeks until further progression upon investigator decision. Also administrated according to the Summary of Product Characteristic (SPC). | Drug | Hepatocellular carcinoma with portal vein thrombosis and without hepatic spread |
Primary outcome
Objective Response Rate (ORR)
Time frame: Through study completion, an average of 4 years
The Objective Response Rate (ORR) is defined as the proportion of patients who have either a Partial Response (PR) or a Complete Response (CR) to treatment. CR and PR are the best overall response across all time points of tumor evaluation. Overall tumor response at each time point is assessed according to the modified RECIST criteria for HCC.
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 5 May 2026.
Related trials for Hepatocellular Carcinoma Non-resectable
Not yet recruitingPhase 2
PEARL Trial: Partial TACE Enhancing Anti-tumor Response With Lenvatinib in Unresectable HCC
Hepatocellular Carcinoma
Active, not recruitingPhase 3
Radiation Therapy With Protons or Photons in Treating Patients With Liver Cancer
Recurrent Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v7
Active, not recruitingPhase 1/2
Nivolumab, Fluorouracil, and Interferon Alpha 2B for the Treatment of Unresectable Fibrolamellar Cancer
Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8
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)
Active, not recruiting
BioPearl™ Microspheres Loaded With Doxorubicin for the Treatment of Unresectable Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma Non-resectable
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.
Etienne Garin, MD PHD principal investigator
Centre de Lutte Contre Le cancer Eugène Marquis
6 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 Selective Internal Radiotherapy, Tremelimumab and Durvalumab in people with Hepatocellular Carcinoma Non-resectable, run by Center Eugene Marquis at 6 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 11 inclusion and 63 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: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
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 Tassadit AMROUN-SEBILLE (0299253137 ext. +33, t.amroun-sebille@rennes.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Through study completion, an average of 4 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 5 May 2026.