ClinicalTrials.gg
RecruitingNCT06796114PREDICT-HCCUpdated Jul 23, 2026

Identification of Innovative Biomarkers to Predict Outcomes in Hepatocellular Carcinoma Treated With Tremelimumab and Durvalumab

An interventional study of blood sample in Hepatocellular Carcinoma, sponsored by Centre Hospitalier Universitaire de Besancon. Recruiting at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Centre Hospitalier Universitaire de Besancon · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 284 studies in Carcinoma, Hepatocellular with a site in France — 54 open to participants now, 85 under way, 14 of them phase 3. Carcinoma, Hepatocellular · France.

Planned enrollment
114th of 215
120 · median 136
Started
2025
with 15 others
No phase
56 of 284
19 open now
Primary completion
2027-06
later than 40 of 84 live
Registered
265th of 284
by date

Among the 284 studies in Carcinoma, Hepatocellular with a site in France, this one is the 114th largest by planned enrollment of the 215 interventional ones that give a count, is one of 16 that started in 2025, is one of 56 with no phase, reaches primary completion later than 40 of the 84 other live ones, and was the 265th registered.

Carcinoma, Hepatocellular

3,650 studies on the registry are indexed under Carcinoma, Hepatocellular; 1,062 are open to participants now.

Browse Carcinoma, Hepatocellular studies →

Open to participants now

54 of the 284 studies in Carcinoma, Hepatocellular with a site in France are open now. Recruiting first, the newest first:

48 more — sign in →

All 54 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 737 Carcinoma, Hepatocellular studies recruiting now, 382 (52%) set no upper age limit and 249 (34%) stop at 75 or younger; 31 take children under 18; 31 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 284 studies in Carcinoma, Hepatocellular with a site in France, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • biomarker, immunotherapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Signed
  2. confirmed hepatocellular carcinoma
  3. Locally advanced, , or unresectable disease
  4. 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 to STRIDE treatment according to approved product label.
  5. defined according to 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.)
  6. Age ≥ 18 years
  7. Patient affiliated to or beneficiary of French social security system
  8. Ability to comply with the study protocol, in the Investigator's judgment.

Exclusion criteria

Exclusion Criteria:

  1. Patients previously exposed to anti-tumor immunotherapy as , anti-PD-L1, or anti-CTLA4 agent or any immune therapy.
  2. Patient with any medical or psychiatric condition or disease, which would make the patient inappropriate for entry into this study
  3. Patient under guardianship, curatorship or under the protection of justice
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Blood sample

    Other: blood sample

Interventions

  • Otherblood sample

    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

This study also gives Durvalumab, Tremelimumab. No intervention listed here names it: that was found by reading the record.

06

What researchers measure

Primary outcomes

  1. real-word overall survival

    defined as the delay from the date of treatment initiation to death from any cause

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

Secondary outcomes

  1. 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.

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

  2. Objective Response Rate (ORR)

    defined as the addition of complete response and partial response rates, evaluated by RECIST citeria v1.1 and mRECIST

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

  3. 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.

    Time frame: through study completion, up to a maximum of 24 months after the inclusion of the last patient

07

Study locations

10 of 10 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Jun 2027, 24 months after the start.

Of 360 non-industry interventional studies with no phase under Carcinoma, Hepatocellular, half reached primary completion within 48 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 76. This study's planned 24 months is below that.

Counting every sponsor, half of 384 studies reached it within 47 months; a quarter within 23 and three quarters within 75.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 10, 2025
First posted
Jan 28, 2025
StartActual
Jun 25, 2025
Primary completionEst.
Jun 25, 2027
CompletionEst.
Jan 31, 2030
Last update
Jul 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06796114
Collaborators
AstraZeneca
Responsible party
Sponsor
First posted
Jan 28, 2025
Start date
Jun 25, 2025
Primary completion
Jun 25, 2027 (estimated)
Completion
Jan 31, 2030 (estimated)
Last update
Jul 23, 2026

Study contacts

Angélique VIENOT, Dr
Contact
a3vienot@chu-besancon.fr
+33 3 81 66 81 66

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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