Epalrestat with HAIC, Donafenib, and Tislelizumab as first-line therapy for unresectable HCC with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial investigates the safety and preliminary effectiveness of combining epalrestat with hepatic arterial infusion chemotherapy (HAIC), donafenib, and tislelizumab as a first-line regimen for patients with unresectable HCC and diabetes. Eligible participants have Child-Pugh A/B liver function, ECOG 0-1, and are 18–80 years old, with unresectable disease confirmed by imaging or pathology. The trial aims to determine whether this quadruple therapy can improve tumor control and patient outcomes while monitoring safety in this population. Key exclusion criteria include decompensated liver disease, extensive metastasis, severe cardiovascular or renal impairment, active infections, and poor performance status.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Diabetes mellitus combined with unresectable advanced HCC (BCLC stage C);
2. Patients who have the need for treatment, prevention and improvement of diabetic neuropathy;
3. Liver function at Child-Pugh grade A or B (≤ 7 points), ECOG PS 0-1;
4. Age 18-80 years old. Confirmed as unrectable HCC through pathological or imaging diagnosis;

Exclusion Criteria:

1. Severe liver dysfunction: Child-Pugh C grade (≥ 8 points) or active hepatic encephalopathy Illness;
2. Extensive extrahepatic metastases (e.g., lung, bone, or peritoneum metastases);
3. Severe cardiovascular diseases: Uncontrolled heart failure, recent myocardial infarction;
4. Renal failure: Creatinine clearance rate \< 30 mL/min;
5. Thrombocytopenia (less than 50×10⁹/L) or coagulation dysfunction (INR greater than 1.5);
6. Active infection (such as uncontrolled hepatitis B virus replication with HBV-DNA \> 2000 IU/mL);
7. ECOG PS ≥ 2 or extremely poor overall condition;
8. Diabetic patients with acute ketoacidosis or during the period of severe infection;
9. Pregnant and lactating women;
10. Known history of other malignancy.

Where it's running

• Yanbian University Hospital
  Yanji, Jilin, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Not yet recruiting
• The First Hospital of China Medical University
  Shenyang, Liaoning, China Active not recruiting
• Liaoning Cancer Hospital
  Shenyang, Liaoning, China Not yet recruiting

Study contacts

• Principal investigator: Haibo Shao — First Hospital of China Medical University
• Study coordinator: Hongbin Zou
• Email: hongbinzou300@gmail.com
• Phone: +8618040026871

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Neoadjuvant tislelizumab plus lenvatinib for resectable hepatocellular carcinoma at high risk of recurrence

  This trial tests whether giving tislelizumab and lenvatinib before surgery can reduce recurrence and improve outcomes in people with resectable hepatocellular carcinoma at high risk of coming back.

  Recruiting Phase 3 Tianjin Medical University Cancer Institute and Hospital · Tianjin · NCT07475026

• Observational cohort for non-alcoholic fatty liver disease and related conditions

  This study is trying to learn more about non-alcoholic fatty liver disease and its related conditions by looking at patients with different stages of the disease and comparing them to people with diabetes and obesity who don't have it.

  Recruiting Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Roma, Rome/lazio/italy · NCT04371042

• Tislelizumab with Tofacitinib and Docetaxel for NSCLC After First-Line Immunotherapy

  This study tests whether adding tofacitinib to tislelizumab and docetaxel helps people with locally advanced or metastatic NSCLC who did not respond to first-line immunotherapy.

  Recruiting Phase 2 Anhui Provincial Hospital · Hefei, Anhui · NCT07925866

• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

  This trial tests whether SYS6010 with Enlonstobart works better than Tislelizumab with gemcitabine and cisplatin for people whose recurrent or metastatic nasopharyngeal cancer has not yet received systemic treatment.

  Recruiting Phase 3 CSPC Megalith Biopharmaceutical Co.,Ltd. · Guangzhou, Guangzhou · NCT07925021

• TACE plus SBRT before liver transplant for hepatocellular carcinoma

  This study tests whether adding SBRT to standard TACE helps liver transplant patients with hepatocellular carcinoma see better outcomes.

  Recruiting AIO-Studien-gGmbH · München · NCT07924943

• Neoadjuvant therapy for locally advanced low rectal cancer: adding fruquintinib to short-course radiotherapy with tislelizumab and CAPOX

  This study tests whether adding fruquintinib to short-course radiotherapy plus tislelizumab and CAPOX before surgery helps people with locally advanced low rectal cancer achieve a better tumor response.

  Recruiting Phase 2 Ruijin Hospital · Shanghai, Shanghai Municipality · NCT07888309

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.