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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCanadian Cancer Trials Group

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • STRIDE (durvalumab + tremelimumab)
  • Durvalumab
  • Lenvatinib

Treatment groups

140 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Canadian Cancer Trials Group

Lead sponsor

AstraZeneca

Collaborator

National Cancer Institute, Naples

Collaborator