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Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma

Phase 1/Phase 2
18 Years
Open (Enrolling)
Metastatic Hepatocellular Carcinoma, Advanced Liver Cancer

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Trial Information

Phase I/II Study of Intravenous Ascorbic Acid in Treatment of Metastatic Hepatocellular Carcinoma

Intravenous Ascorbic Acid (Vitamin C) is a widely used alternative cancer treatment. This
trial will study an intravenous Vitamin C treatment for persons with liver cancer that has
spread, who are also receiving Sorafenib (a standard cancer drug), to see whether the
combination of Vitamin C and Sorafenib is safe and well tolerated. Phase I will involve 6
persons who will receive the Vitamin C for 8 weeks to more specifically assess the safety of
getting Vitamin C in combination with Sorafenib. Phase II will be randomized to receive
either Vitamin C plus Sorafenib or Sorafenib alone for 16 weeks. If Vitamin C has a
beneficial effect on tumour cells, patients may experience a regression of tumor or tumor
markers. Additional benefits include scans at no charge to the patient.

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 ≥

- 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

- 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

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

16 weeks +/- 2 weeks

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

September 2014

Related Keywords:

  • Metastatic Hepatocellular Carcinoma
  • Advanced Liver Cancer
  • 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
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Thomas Jefferson UniversityPhiladelphia, Pennsylvania  19107-6541