Actively Recruiting
STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma
Led by Canadian Cancer Trials Group · Updated on 2026-04-14
140
Participants Needed
11
Research Sites
166 weeks
Total Duration
On this page
Sponsors
C
Canadian Cancer Trials Group
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STRIDE (Durvalumab + Tremelimumab) With Lenvatinib vs STRIDE Alone in Unresectable Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Body weight over 30 kg
- Life expectancy of at least 12 weeks
- Confirmed hepatocellular carcinoma by tissue pathology or clinical criteria
- No prior systemic therapy for hepatocellular carcinoma
- Not eligible for locoregional therapy for unresectable hepatocellular carcinoma; if progressed after locoregional therapy, treatment must be completed at least 28 days before baseline scan
- Barcelona Clinic Liver Cancer (BCLC) stage B (not eligible for locoregional therapy) or stage C
- Child-Pugh Score class A or B7 due to low albumin only
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- At least one measurable lesion not previously irradiated, measurable by CT or MRI per RECIST 1.1
- For active hepatitis B infection, on antiviral therapy initiated prior to randomization and stable viral response required
- Participants with inactive hepatitis B infection must be monitored regularly and start antiviral therapy if viral levels rise
- Active hepatitis C infection must be managed per local practice
- Adequate organ and marrow function within 14 days before enrollment
- Use of highly effective contraception from enrollment through specified periods
- Agreement to avoid blood donation for specified times after treatment
You will not qualify if you...
- History of other cancers except certain treated non-melanoma skin cancers or in-situ cervical cancer with no disease for 5 years or more
- Concurrent chemotherapy, study drug, biologic, or hormonal cancer therapies (except non-cancer hormonal treatments)
- Known fibrolamellar, sarcomatoid, infiltrative, or mixed cholangiocarcinoma and hepatocellular carcinoma
- Clinically significant ascites requiring intervention
- Uncontrolled high blood pressure despite treatment
- Previous treatment with PD1, PD-L1 inhibitors, or anti-CTLA4 agents
- History of primary immunodeficiency, organ transplant, or severe immune-related toxicity from prior immune therapy
- Known HIV infection or active tuberculosis
- Allergy to study drugs or their components
- Use of immunosuppressive medication within 28 days before first dose
- Active or prior autoimmune or inflammatory disorders including inflammatory bowel disease, diverticulitis (except diverticulosis), lupus, sarcoidosis, granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, or uveitis
- Active or uncontrolled illnesses
- History of leptomeningeal carcinomatosis
- Symptomatic or uncontrolled brain metastases requiring treatment
- Major surgery within 28 days before enrollment
- QTcF interval of 470 ms or higher on ECG
- Live attenuated vaccine within 30 days before enrollment
- Lactating participants
- Any condition making protocol treatment unsafe or impairing ability to receive treatment
- Radiotherapy within four weeks before first dose except a single palliative dose up to 14 days before enrollment
- Active or recent gastrointestinal bleeding within 6 months without adequate treatment or high-risk varices without assessment and treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada, T2N 5G2
Actively Recruiting
2
BCCA - Vancouver
Vancouver, British Columbia, Canada, V5Z 4E6
Actively Recruiting
3
Juravinski Cancer Centre at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 5C2
Actively Recruiting
4
Kingston Health Sciences Centre
Kingston, Ontario, Canada, K7L 2V7
Actively Recruiting
5
Waterloo Regional Health Network (WRHN)
Kitchener, Ontario, Canada, N2G 1G3
Actively Recruiting
6
London Health Sciences Centre Research Inc.
London, Ontario, Canada, N6A 5W9
Actively Recruiting
7
Trillium Health Partners - Credit Valley Hospital
Mississauga, Ontario, Canada, L5M 2N1
Actively Recruiting
8
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
9
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
10
CHUM-Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
11
The Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
C
Chris O'Callaghan
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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