Clinical trial · Interventional
A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective
Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with sorafenib versus treatment with sorafenib alone in subjects with metastatic hepatocellular carcinoma. The phase I aspect will assess the safety and efficacy of the concurrent treatments and the phase II aspect will utilize CT (computer-tomography) scans to assess overall tumor response rate and evaluate disease progression
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Liver Cancer | Malignant Liver Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ascorbic Acid + Sorafenib | Drug | — | UNRESOLVED |
| Sorafenib | Drug | Sorafenib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ascorbic Acid + Sorafenib
- description
- Drug: Vitamin C Other Names: Ascorbic Acid, Ascorbate Dosage: Vitamin C : 100 grams (infusion) Phase I: 3x a week for 8 weeks Phase II: 3x a week for 16 weeks Sorafenib: taken daily (oral)
- interventionNames
- Drug: Ascorbic Acid + Sorafenib
- type
- OTHER
- label
- Sorafenib alone
- description
- Sorafenib: taken daily (oral)
- interventionNames
- Drug: Sorafenib
Primary outcomes (1)
- measure
- Number of Participants That Experience Serious Adverse Events.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Metastatic hepatocellular carcinoma * G6PD (glucose-6-phosphate dehydrogenase) status \> lower limit of normal * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5X upper limit (if the creatinine is elevated, but ≤1.5X the ULN, a 24 hour creatinine clearance will be obtained); transaminase (AST/ALT) ≤2.0X upper limit of normal; bilirubin levels ≥ 2 mg/dL; ANC ≥1,500/mm3; Hemoglobin \> 8g/dL; platelet ≥ 100,000/mm3 * Women of childbearing potential will confirm a negative pregnancy test and must practice effective contraception during the study. * Willing and able to provide informed consent and participate in the study procedures. Exclusion Criteria: * Patients with evidence of a significant current psychiatric disorder that would prevent completion of the study as determined by the PI will not be allowed to participate. * Co-morbid medical condition that would affect survival or tolerance as determined by the PI. This includes patients who have not fully recovered from toxicities associated with prior therapy. It also includes subjects who, as determined by the PI, are at risk of experiencing fluid overload (i.e., congestive heart failure). * Patients who currently abuse alcohol or drugs. * Patients with known glomerular filtration rate of \<60ml/min or with nephrotic range proteinuria. * Pregnant or lactating women * Enrollment in active clinical trial/ experimental therapy or IND study within the prior 30 days. * Contraindication for CT or PET/CT as per the PI.
References
Publications (1)
- BACKGROUNDMonti DA, Mitchell E, Bazzan AJ, Littman S, Zabrecky G, Yeo CJ, Pillai MV, Newberg AB, Deshmukh S, Levine M. Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer. PLoS One. 2012;7(1):e29794. doi: 10.1371/journal.pone.0029794. Epub 2012 Jan 17. PMID 22272248