Clinical trial · Interventional
Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC
Phase I-II Clinical Trial of the Safety and Preliminary Efficacy of Hydroxychloroquine Combined With Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of enrollment
Summary
Brief summary (as posted)
Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HCQ | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TACE + HCQ
- description
- Subjects will receive HCQ plus standard of care TACE.
- interventionNames
- Drug: HCQ
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 1 year
- description
- Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient capable of giving informed consent * Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods (Pathologically confirmed HCC by biopsy or HCC 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced MRI or CT or Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alphafetoprotein (AFP) greater than 200 mg/mL. * Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania. * Age 18 years old * Albumin 2.4 g/dL; Total bilirubin 2 mg/dL; INR 1.5 * Creatinine 2.0 mg/dL, AST 121 IU/L; ALT 189 IU/L * Child-Turcotte-Pugh Classification A or B * Eastern Clinical Oncology Group performance status 0 or1. Exclusion Criteria: * Prior TACE * Active GI hemorrhage within 2 weeks of study enrollment * Ascites refractory to medical therapy * Contraindication to receiving HCQ or TACE * Unilobar HCC * Contraindication to contrast enhanced MRI (i.e. unable to undergo follow-up imaging) * Women who are pregnant * Participation in another concurrent treatment protocol
References
Publications (0)
Data not yet available