Clinical trial · Interventional
Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
An Open-label, Multi-center Phase II Study of Durvalumab and Tremelimumab With Lenvatinib as First-line Treatment in Patients With Unresectable Hepatocellular Carcinoma
NCT07081633CI-TRIAL-00111281TREMENDOUS-2active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase II, single-arm, multicentre study, assessing the efficacy and safety of durvalumab and tremelimumab with lenvatinib in participants with unresectable HCC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Lenvatinib | Combination Product | — | UNRESOLVED |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm
- description
- Durvalumab and Tremelimumab with Lenvatinib
- interventionNames
- Drug: Durvalumab
- Drug: Tremelimumab
- Combination Product: Lenvatinib
Primary outcomes (1)
- measure
- Progression free survival (PFS) per RECIST 1.1
- timeFrame
- From the date of first dose until the date of objective PD per RECIST 1.1 or death, whichever came first. It will be assessed when approximately 69 PFS events have occurred (60% maturity), approximately 8 months after the last patients dosed.
- description
- Efficacy endpoint
Secondary outcomes (6)
- measure
- Grade ≥ 3 TRAE within 6 months after the initiation of study intervention
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed HCC based on histopathological findings from tumor tissues or radiologically findings. * Must not have received prior systemic therapy for unresectable HCC. * Barcelona Clinic Liver Cancer (BCLC) stage B (that is not eligible for locoregional therapy) or stage C. * Child-Pugh Score class A. * ECOG performance status of 0 or 1 at enrollment. * At least 1 measurable lesion per RECSIT 1.1 guidelines Exclusion Criteria: * Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥2 from previous anticancer therapy. * History of hepatic encephalopathy within past 12 months or requirement for medications to prevent or control encephalopathy. * Clinically meaningful ascites. * Patients with main portal vein thrombosis. * Active or prior documented GI bleeding. * Patient currently exhibits symptomatic or uncontrolled hypertension. * Patients co-infected with HBV and HCV, or co-infected with HBV and hepatitis D virus (HDV) * Uncontrolled intercurrent illness
References
Publications (0)
Data not yet available
No reference posted for this study.