Safety and Efficacy of Tremelimumab+Durvalumab(MEDI4736)+TACE in Unresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age19+
SponsorYoon Jun Kim
About this trial
Safety and Efficacy Evaluation of Tremelimumab Plus Durvalumab(MEDI4736) in Combination with Concurrent Transarterial Chemoembolization in Unresectable Hepatocellular carcinoma
Eligibility criteria
Qualifiers
1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Written informed consent and any locally required authorization from the patient/legal representative prior to performing any protocol-related procedures, including screening evaluations.
Hemoglobin ≥9.0 g/dL
Absolute neutrophil count (ANC) ≥1500 per mm3
Platelet count ≥75,000 per mm3
Disqualifiers
1. Eligible for potentially curative treatment (surgical resection, radiofrequency ablation or immediate liver transplantation).
Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab and/or tremelimumab may be included at the discretion of the Investigator.
Patients with vitiligo or alopecia
Trial design
Treatments tested in this trial
- Tremelimumab Plus Durvalumab (MEDI4736)
- Transarterial chemoembolization (TACE)
Treatment groups
24 Participants
are divided into 1 treatment groupSponsors and collaborators
Yoon Jun Kim
Lead sponsor
Seoul National University Hospital
Sponsor institution
AstraZeneca
Collaborator
Source ClinicalTrials.gov