Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFujian Provincial Hospital
About this trial
This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).
Eligibility criteria
Qualifiers
Be willing and able to enrollment in this study, signing the informed consent form;
Age between 18 and 75 years old, male or female patients;
Child-Pugh class A;
Indocyanine green 15 min retention rate (ICGR-15) <15%;
Disqualifiers
Patients with a diagnosis of initial unresectable HCC, assessed as complete response (CR) or Progressive disease (PD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combined with Sintilimab;
Tumor combined with cancerous thrombus in the inferior vena cava and the tumor has developed extrahepatic metastasis;
Treatment with other antitumor therapy such as targeted drugs, PD-1/PD-L1 inhibitors, surgery, TACE, radiotherapy, FOLFOX systemic chemotherapy, and locus coeruleus granule drugs prior to study entry;
History of allergy to Lenvatinib, Sintilimab and their components;
Trial design
Treatments tested in this trial
- TACE, Lenvatinib combination with Sintilimab sequential radiotherapy
Treatment groups
28 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov