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Hepatocellular CarcinomaPhase 2SLIDE-HCCNCT06880523

STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma

A Phase 2 study testing STRIDE (durvalumab + tremelimumab), Durvalumab and Lenvatinib in people with Hepatocellular Carcinoma, run by Canadian Cancer Trials Group at 13 sites in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to compare the effects on participants' and liver cancer by adding a drug that is used on its own to treat this disease to a combination of two other drugs which is also used to treat liver cancer, compared to the two-drug combination alone. 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?
STRIDE (durvalumab + tremelimumab), Durvalumab and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
13 sitesCanada
Study dates
21 Oct 2025to 31 Dec 2028
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 years.
  • Body weight > 30 kg.
  • Life expectancy of at least 12 weeks.
  • Confirmed HCC based on histopathological findings from tumour tissues or clinically by AASLD criteria in cirrhotic participants.
  • Must not have received prior systemic therapy for HCC.
  • Must not be eligible for locoregional therapy for unresectable HCC. For patients who progressed after locoregional therapy for HCC, locoregional therapy must have been completed ≥28 days prior to the baseline scan of the abdomen and pelvis for the current study.
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  • Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C.
  • Child-Pugh Score class A or B7 based on low albumin (albumin 25-27 g/L) only.
  • Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • At least 1 measurable lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have a short axis ≥15 mm) with computerized tomography (CT) or magnetic resonance imaging (MRI), and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines. A lesion which progressed after previous ablation or TACE could be measurable if it meets these criteria.
  • Participants with active HBV infection [characterized by positive hepatitis B virus surface antigen (HBsAg) and/or positive hepatitis B core antibodies (anti-HBcAb) with detectable HBV deoxyribonucleic acid (DNA) (≥10 IU/mL or above the limit of detection per local lab standard)] are eligible if:
  • The participant is being treated with antiviral therapy, as per institutional practice. The HBV antiviral therapy must be initiated prior to randomization, and the participant must remain on antiviral therapy for the study duration and for 6 months after the last dose of study medication.
  • The participant must show evidence of HBV stabilization or signs of viral response (eg, reduction of HBV DNA levels) prior to enrollment
  • Participants who test positive for HBsAg or anti-hepatitis B core (HBc) with undetectable HBV DNA (< 10 IU/mL or under the limit of detection per local lab standard) are eligible and do not require antiviral therapy prior to randomization.
  • These participants will be tested at every cycle to monitor HBV DNA levels and initiate antiviral therapy if HBV DNA is detected (≥ 10 IU/mL or above the limit of detection per local lab standard).
  • If HBV DNA becomes detectable during study treatment, antiviral therapy must be initiated, and the participant must remain on antiviral therapy during the study treatment period and for 6 months after the last dose of study medication.
  • Participants with active HCV infection (as characterized by the presence of detectable HCV ribonucleic acid [RNA] or anti-HCV antibody [anti-HCV]) must be managed per local institutional practice for the study and for 6 months after the last dose of study treatment.
  • Adequate organ and marrow function, within 14 days prior to enrollment.
  • Participants of childbearing potential must have agreed to use a highly effective contraceptive method from enrollment to 90 days after the last dose of durvalumab or 180 days after the last dose of tremelimumab (whichever date is later).
  • Participants must agree not to donate blood for at least 90 days following the last infusion of durvalumab or tremelimumab, or until 7 days after the last dose of lenvatinib, whichever is longest.

Who cannot join

  • Participants with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other tumours curatively treated with no evidence of disease for ≥ 5 years.
  • Any concurrent chemotherapy, study drug, or biologic or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable.
  • Known fibrolamellar HCC, sarcomatoid HCC, infiltrative-type HCC or mixed cholangiocarcinoma and HCC.
  • Clinically meaningful ascites, defined as ascites requiring non-pharmacologic intervention
  • Uncontrolled arterial hypertension defined by a systolic pressure ≥ 150 mm Hg or diastolic pressure ≥ 90 mm Hg or other hypertensive cardiovascular complications despite standard medical management.
  • Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab, or an anti-CTLA4, including tremelimumab.
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  • History of primary immunodeficiency, history of organ transplant or prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
  • Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies) or active tuberculosis infection (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).
  • Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.
  • Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab or tremelimumab
  • Active or prior documented autoimmune or inflammatory disorders including inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), diverticulitis (with the exception of diverticulosis), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.
  • Patients with active or uncontrolled intercurrent illness
  • History of leptomeningeal carcinomatosis.
  • Symptomatic or uncontrolled brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation and/or corticosteroids.
  • Major surgical procedure (as defined by the Investigator) within 28 days prior to enrollment.
  • Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
  • Receipt of live attenuated vaccination (examples include, but are not limited to, vaccines for measles, mumps, and rubella, live attenuated influenza vaccine (nasal), chicken pox vaccine, oral polio vaccine, rotavirus vaccine, yellow fever vaccine, BCG vaccine, typhoid vaccine and typhus vaccine) within 30 days prior to enrollment.
  • Lactating participants.
  • Any active disease condition which would render the protocol treatment dangerous or impair the ability of the patient to receive protocol therapy.
  • Receipt of radiotherapy within four weeks of first planned dose of durvalumab or tremelimumab, except for a single dose of radiation up to 8 Gray (equal to 800 RAD) delivered with palliative intent for pain control up to 14 days before enrollment.
  • Active or prior documented GI bleeding (e.g. esophageal varices or ulcer bleeding) within 6 months. (Note: For patients with a history of GI bleeding more than 6 months prior or assessed as high risk for esophageal varices by the Investigator or main trunk portal vein thrombosis (Vp4), adequate endoscopic assessment and treatment of varices as per institutional standards is required prior to enrollment.)

Trial locations and contacts

13 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chris O'Callaghan contact

613-533-6430

cocallaghan@ctg.queensu.ca

13 sites in 1 country

Canada13 sites, 13 recruiting

  • Arthur J.E. Child Comprehensive Cancer Centre

    Calgary, Alberta, T2N 5G2

    Vincent Tam, 403 521-3706

    Recruiting

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

    Shivani Dadwal

    Recruiting

  • BCCA - Kelowna

    Kelowna, British Columbia, V1Y 5L3

    David Nguyen, 250 712-3900

    Recruiting

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

    Gordon Moffat

    Recruiting

  • Waterloo Regional Health Network (WRHN)

    Kitchener, Ontario, N2G 1G3

    Anupam Batra

    Recruiting

  • London Health Sciences Centre Research Inc.

    London, Ontario, N6A 5W9

    Elena Tsvetkova, 519 685-8500

    Recruiting

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

    Mala Bahl, 416 521-4118

    Recruiting

  • CHUM-Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

    Helene Castel, 514 890-8000 ext. 35705

    Recruiting

  • The Jewish General Hospital

    Montreal, Quebec, H3T 1E2

    Petr Kavan, 514 398-1444

    Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

    Dominick Bosse, 613 737-7700

    Recruiting

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

    Osama Ahmed, 306 655-2662

    Recruiting

  • University Health Network

    Toronto, Ontario, M5G 2M9

    Jennifer Knox, 416 946-2399

    Recruiting

  • BCCA - Vancouver

    Vancouver, British Columbia, V5Z 4E6

    Howard Lim, 604 877-6000 ext. 672699

    Recruiting

Other trials in Canada

About this study

Official title: A Phase II Study of STRIDE (Durvalumab + Tremelimumab) With Lenvatinib Versus STRIDE Alone in Patients With Unresectable Hepatocellular Carcinoma (SLIDE-HCC)

The purpose of this study is to compare the effects on participants' and liver cancer by adding a drug that is used on its own to treat this disease to a combination of two other drugs which is also used to treat liver cancer, compared to the two-drug combination alone.

Read the detailed description

An earlier clinical trial showed that a single drug treatment for liver cancer helped stabilize or shrink participants' liver cancer and extend the time before their cancer got worse. A different clinical trial showed that a different two-drug combination helped extend how long participants with liver cancer lived after starting the treatment. Combinations of drugs that are similar to these treatments have been studied in a few people and seem promising, but it is not clear if the combination of all three drugs being used in this study can offer better results than standard treatment.

Being tested
STRIDE (durvalumab + tremelimumab), Durvalumab, Lenvatinib
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STRIDE (durvalumab + tremelimumab)Drug

    As first treatment

  • DurvalumabDrug

    monotherapy every 4 weeks

  • LenvatinibDrug

    Daily

Study groups in NCT06880523
Study groupRoleWhat they receive
STRIDE (durvalumab + tremelimumab)Active comparatorNot described
Receives: Drug: STRIDE (durvalumab + tremelimumab); Drug: Durvalumab
STRIDE (durvalumab + tremelimumab) + LenvatinibExperimentalNot described
Receives: Drug: STRIDE (durvalumab + tremelimumab); Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival using RECIST 1.1

    Measured: 32 months

Secondary outcomes (3)

  1. Overall Survival

    Measured: 32 months

  2. Number and Severity of Adverse Events using CTCAE

    Measured: 32 months

  3. Objective Response Rate using RECIST 1.1

    Measured: 32 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2025
  2. Study start21 Oct 2025
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06880523
Sponsor's protocol ID
HE2
Acronym
SLIDE-HCC
Status last verified
Oct 2025
First submitted
11 Mar 2025
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing STRIDE (durvalumab + tremelimumab), Durvalumab and Lenvatinib in people with Hepatocellular Carcinoma, run by Canadian Cancer Trials Group at 13 sites in Canada.

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 20 inclusion and 21 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 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Canada. 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 Chris O'Callaghan (613-533-6430, cocallaghan@ctg.queensu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival using RECIST 1.1 (time frame: 32 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 NCT06880523.

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 11 Aug 2026.

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