RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Epalrestat for HCC - Hepatocellular Carcinoma

This study wants to measure the comprehensive therapeutic how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07557914 · Haibo Shao · enrollment listed as 32

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Epalrestat, Donafenib + Tislelizumab, or HAIC. The registry lists allocation as na. This study wants to measure the comprehensive therapeutic how well it works 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.

They plan to enroll about 32 people at 4 sites. Taking part typically means taking a study drug (or dummy pill), a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Multicenter, Prospective, Single-arm Clinical Study Evaluating the Efficacy and Safety of Epalrestat Combined With Hepatic Arterial Chemotherapy Infusion (HAIC), Donafenib and Tislelizumab as First-line Treatment for Patients With Unresectable Hepatocellular Carcinoma and Diabetes

Interventions: Epalrestat, Donafenib + Tislelizumab, HAIC

Primary outcome (registry wording): 12-month Event-free survival (EFS) Rate

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
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;

Who the registry excludes

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;
Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);
Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \> 2000 IU/mL);
ECOG PS ≥ 2 or extremely poor overall condition;

Public study contact (from the registry)

Hongbin Zou

+8618040026871

hongbinzou300@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

4 listed

Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (not_yet_recruiting)
Yanbian University Hospital — Yanji, Jilin, China (recruiting)
The First Hospital of China Medical University — Shenyang, Liaoning, China (active_not_recruiting)
Liaoning Cancer Hospital — Shenyang, Liaoning, China (not_yet_recruiting)

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FAQ about this NCT record

Is NCT07557914 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07557914?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07557914?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary