Clinical trial · Interventional
CTLA-4 /PD-L1 Blockade Following Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC (Hepatocellular Carcinoma) Using Durvalumab and Tremelimumab
The Effect of CTLA-4/PD-L1 Blockade Following Drug-eluting Bead Transarterial Chemoembolization (DEB-TACE) in Patients With Intermediate Stage of HCC Using Durvalumab (MEDI4736) and Tremelimumab
NCT03638141CI-TRIAL-00093748completedPhase 2Results postedClinicalTrials.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)
The purpose of this study is to determine the safety and efficacy of immunotherapy durvalumab and tremelimumab combined with DEB-TACE in patients with Hepatocellular Carcinoma.
Conditions
Conditions (2)
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 |
| Intermediate Stage of Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Durvalumab | Drug | Durvalumab | ALIAS |
| Tremelimumab | Drug | Tremelimumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Durvalumab in combination with Tremelimumab
- description
- Drug: Durvalumab 1500mg IV + Tremelimumab 300 mg IV , single infusion about 2 weeks after first DEB-TACE procedure. Drug: Durvalumab (monotherapy) 1500 mg IV infusion every 4 weeks, for maximum 13 doses/cycles.
- interventionNames
- Drug: Durvalumab
- Drug: Tremelimumab
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- up to 26 months
- description
- Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on mRECIST criteria. CR = Disappearance of any intratumoral arterial enhancement in all target lesions, PR = At least a 30% decrease in the sum of diameters of viable (enhancement in the arterial phase) target lesions, taking as reference the baseline sum of the diameters of target lesions.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent form * Age ≥18 years. * Patients with diagnosis of HCC either by high-resolution imaging (triple-phase CT or MRI) and/or by tumor biopsy. * Patient is not on systemic treatment for diagnosis of HCC * HCC meeting Barcelona Clinic Liver Cancer (BCLC) stage B (intermediate stage), with measurable lesions on CT or MRI and without extrahepatic spread * Have measurable disease * Have disease that responds to DEB-TACE * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Child-Pugh Score of A or early B (score ≤8) without clinically significant ascites * Body weight \>30 kg * Patients must have adequate organ function defined by study-specified laboratory tests. * Evidence of post-menopausal status or negative pregnancy test * Willing and able to comply with study procedures * Willing to undergo a liver biopsy Exclusion Criteria: * Anyone involved with the planning and/or conduct of the study. * Has participated in another investigational study during the last 6 months. * Any concurrent anticancer therapy or received therapy ≤30 days prior to study. * Major surgical procedure at the time of study enrollment or within 28 days prior to the first dose of study drug. * Have a vascular invasion or extrahepatic tumor. * Main portal vein thrombosis present on imaging. * Uncontrolled hepatic encephalopathy at time of enrollment. - Ascites within 6 weeks prior to study treatment. * Any contraindications for embolization. * Has an active infection such as Tuberculosis, HIV, hepatitis B or C. * History of another primary malignancy or myeloproliferative disorder. * History of leptomeningeal carcinomatosis. * History of active primary immunodeficiency. * Any unresolved toxicities from previous anticancer therapy. * Active or prior documented GI bleeding due to ulcer or esophageal varices bleeding within 6 months. * History or current use of immunosuppressive medications within 14 days prior to study medications. * Major surgical procedure within 28 days prior to the first dose of IP. * Has an active known or suspected autoimmune disease. * Patients with hypothyroidism. * Any active skin conditions. * History of allogenic organ transplantation. * Significant heart disease. * Patients weighing \< 30 kg. * Patients with celiac disease not controlled by diet alone. * Patient with uncontrolled intercurrent illness including, but not limited to, uncontrolled infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Have received a live vaccine within 30 days prior to study drug. * Woman who are pregnant or breastfeeding. * Known allergy or hypersensitivity to the study drug. * Have received durvalumab, tremelimumab, anti-PD-1, anti-PD-L1 or anti-CTLA-4 in a prior study. * Unwilling or unable to follow the study schedule for any reason.
References
Publications (0)
Data not yet available
No reference posted for this study.