A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective
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ClinicalTrials.gov Identifier: NCT01754987 |
Recruitment Status :
Completed
First Posted : December 21, 2012
Results First Posted : August 23, 2018
Last Update Posted : August 23, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Metastatic Hepatocellular Carcinoma Advanced Liver Cancer | Drug: Ascorbic Acid + Sorafenib Drug: Sorafenib | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 5 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | January 2016 |

Arm | Intervention/treatment |
---|---|
Experimental: Ascorbic Acid + Sorafenib
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) |
Drug: Ascorbic Acid + Sorafenib
Other Names:
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Sorafenib alone
Sorafenib: taken daily (oral)
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Drug: Sorafenib
Other Name: Nexavar |
- Number of Participants That Experience Serious Adverse Events. [ Time Frame: 16 weeks +/- 2 weeks ]The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with sorafenib therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE)v4.0
- Overall Tumor Response Rate [ Time Frame: 16 weeks +/- 2 weeks ]To utilize CT or PET/CT scans to assess overall tumor response rate (complete) in subjects with advanced metastatic hepatocellular cancer treated with the combination of ascorbic acid and sorafenib versus sorafenib alone.
- Mean Value Collected Using the Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument [ Time Frame: 16 weeks +/- 2 weeks ]To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G will be summarized at multiple time points. Five-point scale from 0 (not at all) to 4 (very much)
- Number of Participants That Are Alive After 15 Weeks of Treatment. [ Time Frame: 15 weeks+ ]To evaluate duration of tumor response and progression-free survival

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754987
United States, Pennsylvania | |
Thomas Jefferson University | |
Philadelphia, Pennsylvania, United States, 19107 |
Principal Investigator: | Daniel A Monti, MD, MBA | Thomas Jefferson University |
Responsible Party: | Thomas Jefferson University |
ClinicalTrials.gov Identifier: | NCT01754987 |
Other Study ID Numbers: |
12D.424 |
First Posted: | December 21, 2012 Key Record Dates |
Results First Posted: | August 23, 2018 |
Last Update Posted: | August 23, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Vitamins Malignant Tumor, Tumour Integrative Medicine Complementary Medicine Alternative Medicine Antioxidants Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents |
Physiological Effects of Drugs Micronutrients Growth Substances Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Radiation-Sensitizing Agents Liver Cancer |
Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases Ascorbic Acid |
Sorafenib Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Antineoplastic Agents Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antioxidants Protective Agents |