Hepatocellular CarcinomaPREDICT-HCCNCT06796114
Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab
A study testing blood sample in people with Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire de Besancon at 10 sites in France.
Trial summary
Several cancer immunotherapies that target the PD-L1/PD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC. In particular, atezolizumab selectively targets PD-L1 to prevent interaction with receptors PD-1 and B7-1, thus reversing T-cell suppression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 10 sitesFrance
- Study dates
- 25 Jun 2025to 31 Jan 2030
- Phase
- Interventional
- 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
- Signed informed consent
- Histologically confirmed hepatocellular carcinoma
- Locally advanced, metastatic, or unresectable disease
- Patient who had not previously received systemic anti-cancer treatment and are eligible to STRIDE therapy according to investigator decision in routine care and who have no contraindications to STRIDE treatment according to approved product label.
- Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
- Age ≥ 18 years
- Patient affiliated to or beneficiary of French social security system
- Ability to comply with the study protocol, in the Investigator's judgment.
Who cannot join
- Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- Patient under guardianship, curatorship or under the protection of justice
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
France10 sites, 10 recruiting
- Recruiting
CHU de Besançon
Besançon
Angélique VIENOT, Dr
- Recruiting
CH de Chalon sur Saône
Chalon-sur-Saône
Pierre VERDIER-DAVIOUD, Dr
- Recruiting
CHU Grenoble
Grenoble
Thomas DECAENS, Dr
- Recruiting
CH de Mulhouse
Mulhouse
Stéphanie HUSSON-WETZEL, Dr
- Recruiting
Hôpital Beaujon - APHP
Paris
Mohamed BOUATTOUR, Dr
- Recruiting
Hôpital Henri Mondor - APHP
Paris
Hélène REGNAULT, Dr
- Recruiting
Hôpital La Pitié Salpêtrière - APHP
Paris
Manon ALLAIRE, Dr
- Recruiting
CHU Poitiers
Poitiers
Valentin ROLLE, Dr
- Recruiting
CHU de Reims
Reims
Alexandra HEURGUE, Dr
- Recruiting
Centre Paul Strauss
Strasbourg
Meher BEN ABDELGHANI, Dr
About this study
Several cancer immunotherapies that target the PD-L1/PD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC. In particular, atezolizumab selectively targets PD-L1 to prevent interaction with receptors PD-1 and B7-1, thus reversing T-cell suppression. Moreover, atezolizumab in combination with bevacizumab, a monoclonal antibody that targets VEGF and inhibits angiogenesis, is associated with an objective response rate of 27.3% (Cheng et al. 2021; Finn et al. 2020). This tumor response has led to FDA (Food and Drug Administration) and EMA (European Medicines Agency) approvals, in first-line treatment in unresectable HCC.
Combinations studies evaluating anti-CTLA4 and anti-PD1/PDL1 antibodies displayed greater benefits (Abou-Alfa et al. 2022). In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, a single priming dose of tremelimumab (anti-CTLA-4) plus durvalumab (anti-PD-L1) in the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen significantly improved OS versus sorafenib; durvalumab monotherapy was noninferior to sorafenib for OS.
Read more
In the HIMALAYA study, STRIDE regimen induced long term survival (defined as the absence of progression above 36 months following inclusion) in 103 out of the 393 patients exposed to this strategy (26%).
The identification of biomarkers allowing the prediction of immunotherapy efficacy in HCC is still an unmet medical need.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- blood sample
- Keywords
- biomarker, immunotherapy
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleOther
A total of 48 ml of blood will be collected at baseline (before STRIDE initiation):
- 6 EDTA 6 ml tubes for PBMC collection
- 2 EDTA 6 ml tube for plasma collection
| Study group | Role | What they receive |
|---|---|---|
| Blood sample | Experimental | Not described Receives: Other: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
real-word overall survival
defined as the delay from the date of treatment initiation to death from any cause
Measured: through study completion, up to a maximum of 24 months after the inclusion of the last patient
Secondary outcomes (3)
real-word progression-free-survival
defined as the delay from the date of treatment initiation to the disease progression or death from any cause whichever occurs first, evaluated by RECIST criteria v1.1 and mRECIST.
Measured: through study completion, up to a maximum of 24 months after the inclusion of the last patient
Objective Response Rate (ORR)
defined as the addition of complete response and partial response rates, evaluated by RECIST citeria v1.1 and mRECIST
Measured: through study completion, up to a maximum of 24 months after the inclusion of the last patient
Disease control rate (DCR)
defined as the addition of complete response, partial response, and stable disease rates evaluated by RECIST criteria v1.1 and mRECIST.
Measured: through study completion, up to a maximum of 24 months after the inclusion of the last patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start25 Jun 2025
- Primary completion25 Jun 2027 (estimated)
- Study completion31 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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796114
- Sponsor's protocol ID
- 2024-931
- Other IDs
- 2024-A02783-44
- Acronym
- PREDICT-HCC
- Status last verified
- Jul 2026
- First submitted
- 10 Jan 2025
- Last updated
- 23 Jul 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab
- ClinicalTrials.gov ID
- NCT06796114
- Acronym / sponsor ID
- PREDICT-HCC / 2024-931
- Conditions
- Hepatocellular Carcinoma
- Keywords
- biomarker, immunotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 25 Jun 2027 (estimated)
- Study completion
- 31 Jan 2030 (estimated)
- First posted
- 28 Jan 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.
Several cancer immunotherapies that target the PD-L1/PD-1 pathway (i.e., checkpoint inhibitors) show promising clinical activity in patients with HCC. In particular, atezolizumab selectively targets PD-L1 to prevent interaction with receptors PD-1 and B7-1, thus reversing T-cell suppression. Moreover, atezolizumab in combination with bevacizumab, a monoclonal antibody that targets VEGF and inhibits angiogenesis, is associated with an objective response rate of 27.3% (Cheng et al. 2021; Finn et al. 2020). This tumor response has led to FDA (Food and Drug Administration) and EMA (European Medicines Agency) approvals, in first-line treatment in unresectable HCC.
Combinations studies evaluating anti-CTLA4 and anti-PD1/PDL1 antibodies displayed greater benefits (Abou-Alfa et al. 2022). In the Phase 3 HIMALAYA study (NCT03298451) in uHCC, a single priming dose of tremelimumab (anti-CTLA-4) plus durvalumab (anti-PD-L1) in the STRIDE (Single Tremelimumab Regular Interval Durvalumab) regimen significantly improved OS versus sorafenib; durvalumab monotherapy was noninferior to sorafenib for OS.
In the HIMALAYA study, STRIDE regimen induced long term survival (defined as the absence of progression above 36 months following inclusion) in 103 out of the 393 patients exposed to this strategy (26%).
The identification of biomarkers allowing the prediction of immunotherapy efficacy in HCC is still an unmet medical need.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood sample | Experimental | Other: blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed informed consent
- Histologically confirmed hepatocellular carcinoma
- Locally advanced, metastatic, or unresectable disease
- Patient who had not previously received systemic anti-cancer treatment and are eligible to STRIDE therapy according to investigator decision in routine care and who have no contraindications to STRIDE treatment according to approved product label.
- Measurable disease defined according to RECIST v1.1 guidelines (Note: Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation.)
Key exclusion criteria (3 listed)
- Patients previously exposed to anti-tumor immunotherapy as anti-PD-1, anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
- Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
- Patient under guardianship, curatorship or under the protection of justice
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 |
|---|---|---|
| blood sampleA total of 48 ml of blood will be collected at baseline (before STRIDE initiation): * 6 EDTA 6 ml tubes for PBMC collection * 2 EDTA 6 ml tube for plasma collection | Other | Blood sample |
Primary outcome
real-word overall survival
Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient
defined as the delay from the date of treatment initiation to death from any cause
3 secondary outcomes
real-word progression-free-survival
Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient
Objective Response Rate (ORR)
Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient
Disease control rate (DCR)
Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient
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 23 Jul 2026.
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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.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Hepatocellular Carcinoma, run by Centre Hospitalier Universitaire de Besancon 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 8 inclusion and 3 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 23 Jul 2026. 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.
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 Angélique VIENOT, Dr (+33 3 81 66 81 66, a3vienot@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
real-word overall survival (time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient). 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 23 Jul 2026.