Trial Outcomes & Findings for A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective (NCT NCT01754987)

Last Updated: 2025-05-04

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

5 participants

Primary outcome timeframe

16 weeks +/- 2 weeks

Results posted on

2025-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	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) Ascorbic Acid + Sorafenib	Sorafenib Alone Sorafenib: taken daily (oral) Sorafenib
Overall Study STARTED	5	0
Overall Study COMPLETED	5	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Vitamin C in the Treatment of Liver Cancer to Determine if it is Safe and Effective

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 16 weeks +/- 2 weeks

Population: The trial was closed early due to lack of accrual. The data were not collected or analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks +/- 2 weeks

Population: The trial was closed early due to lack of accrual. The data were not collected or analyzed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks +/- 2 weeks

Population: The trial was closed early due to lack of accrual. The data were not collected or analyzed.

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)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 15 weeks+

Population: The trial was closed early due to lack of accrual. The data were not collected or analyzed.

To evaluate duration of tumor response and progression-free survival

Outcome measures

Outcome data not reported

Adverse Events

Ascorbic Acid + Sorafenib

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Sorafenib Alone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Ascorbic Acid + Sorafenib n=5 participants at risk 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) Ascorbic Acid + Sorafenib	Sorafenib Alone Sorafenib: taken daily (oral) Sorafenib
General disorders Dehydration	20.0% 1/5 • Number of events 1	— 0/0

Other adverse events

Other adverse events
Measure	Ascorbic Acid + Sorafenib n=5 participants at risk 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) Ascorbic Acid + Sorafenib	Sorafenib Alone Sorafenib: taken daily (oral) Sorafenib
Blood and lymphatic system disorders Elevated Creatinine	40.0% 2/5 • Number of events 2	— 0/0
Infections and infestations Thrush	20.0% 1/5 • Number of events 1	— 0/0
Blood and lymphatic system disorders Nosebleed	20.0% 1/5 • Number of events 1	— 0/0
Blood and lymphatic system disorders Low Platelet count	40.0% 2/5 • Number of events 2	— 0/0

Additional Information

Dr. Daniel Monti

Sidney Kimmel Cancer Center at Thomas Jefferson University

Phone: 215 955-2221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Ascorbic Acid + Sorafenib n=5 Participants 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) Ascorbic Acid + Sorafenib	Sorafenib Alone Sorafenib: taken daily (oral) Sorafenib	Total n=5 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	—	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	—	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants	—	5 participants n=5 Participants