Active — Not RecruitingPhase 3

Durvalumab and Tremelimumab as First Line Treatment in Participants With Advanced Hepatocellular Carcinoma (HCC)

United States, France111 participantsStarted 2023-06-27

Plain-language summary

This study will assess the safety and efficacy of Single Tremelimumab Regular Interval Durvalumab (STRIDE) as first-line therapy in participants with advanced unresectable HCC.

Who can participate

Age range18 Years – 130 Years

SexALL

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Inclusion criteria

✓. Child-Pugh score B7 or B8 with a WHO/ECOG PS of 0-1 at enrolment, without main trunk portal vein thrombosis.
✓. Child-Pugh class A with a WHO/ECOG PS of 2 at enrolment, without main trunk portal vein thrombosis (ie, ECOG PS 2 participants with main portal vein tumour thrombosis are excluded from this study).
✓. Child-Pugh class A with WHO/ECOG PS of 0-1 at enrolment and with chronic main trunk portal vein thrombosis

Exclusion criteria

✕. Malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence, or
✕. Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or lentigo maligna that has undergone potentially curative therapy, or
✕. Adequately treated carcinoma in situ without evidence of disease

What they're measuring

Incidence of grade 3 or 4 possibly related to treatment adverse events (PRAEs)

Timeframe: From the date of first dose of IMP until 6 months after the initiation of study intervention

Objective response rate (ORR)

Timeframe: From the first dose of IMP until progression, or the last evaluable assessment in the absence of progression [approx. up to 33 months]

Trial details

NCT IDNCT05883644

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-30

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