Epalrestat Combined With HAIC, Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable HCC and Diabetes
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHaibo Shao
About this trial
The purpose of this study is to evaluate the comprehensive therapeutic efficacy and safety profile of the epalrestat combined with hepatic artery infusion chemotherapy (HAIC), donafenib and tislelizumab quadruple regimen in patients with unresectable hepatocellular carcinoma (HCC) and diabetes.
Eligibility criteria
Qualifiers
Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);
Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;
Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;
Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;
Disqualifiers
Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;
Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);
Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;
Renal failure: Creatinine clearance rate < 30 mL/min;
Trial design
Treatments tested in this trial
- Epalrestat
- Donafenib + Tislelizumab
- HAIC
Treatment groups
32 Participants
are divided into 1 treatment groupSponsors and collaborators
Haibo Shao
Lead sponsor
First Hospital of China Medical University
Sponsor institution
First Hospital of China Medical University
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator
The General Hospital of Northern Theater Command
Collaborator
The Affiliated Hospital of Yanbian University
Collaborator
Harbin Medical University Third Affiliated Hospital
Collaborator
Source ClinicalTrials.gov