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Kinase Inhibitor
Sorafenib + Hydroxychloroquine for Liver Cancer
Phase 2
Recruiting
Led By Sukeshi Patel Arora, MD
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Child-Pugh class A or B7 liver function
Cytologically or histologically confirmed advanced or metastatic HCC. If no histological diagnosis, patient must have imaging studies compatible with HCC.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial is testing if the cancer drug sorafenib, when combined with the drug hydroxychloroquine, is more effective than sorafenib alone in treating advanced liver cancer.
Who is the study for?
This trial is for adults with advanced liver cancer who have either not had systemic treatments or those whose disease progressed after at least 4 weeks on sorafenib. They must be in good physical condition, not candidates for curative treatment, and have a life expectancy over 3 months. Exclusions include allergies to similar drugs as HCQ, certain uncontrolled illnesses, brain metastases, and pregnancy.Check my eligibility
What is being tested?
The study tests if combining Hydroxychloroquine (HCQ) with Sorafenib improves outcomes in advanced liver cancer compared to Sorafenib alone. It's specifically for patients new to treatment or those whose cancer grew despite prior Sorafenib use.See study design
What are the potential side effects?
Potential side effects may include digestive issues like nausea and diarrhea from HCQ; skin reactions; eye problems such as retinopathy; and heart complications including arrhythmias. Sorafenib can cause hand-foot skin reactions, high blood pressure, fatigue, and increased risk of bleeding.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My liver function is moderately to mildly impaired.
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My liver cancer is confirmed and advanced or has spread.
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I agree to use two forms of birth control if I'm a woman not in menopause or surgically sterile, or a barrier method if I'm a man.
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My recent blood tests meet the study's health requirements.
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I am 18 years old or older.
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I am fully active or can carry out light work.
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I cannot undergo surgery or transplantation to cure my condition.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to tumor progression evaluated via tumor imaging
Trial Design
2Treatment groups
Experimental Treatment
Group I: Progress on sorafenibExperimental Treatment2 Interventions
As second-line treatment, we will add hydroxychloroquine (HCQ) to sorafenib (SOR) dose the patient was tolerating at the time of progression.
Group II: No prior systemic treatmentExperimental Treatment2 Interventions
Sorafenib (SOR)-naïve patients receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1). In clinical practice, dose reduction of SOR is often required. Therefore, on C1D15, the clinician will dose-reduce sorafenib based on toxicity and hydroxychloroquine (HCQ) 400 mg PO daily will be started. C2D1 of each cohort, toxicity of HCQ will be assessed. Dose reductions due to adverse events (AEs) to each agent are allowed for SOR per standard of care and/or HCQ for grade 3+ AE.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Hydroxychloroquine
FDA approved
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
452 Previous Clinical Trials
91,342 Total Patients Enrolled
Sukeshi Patel Arora, MDPrincipal InvestigatorCancer Therapy & Research Center University of Texas Health Science Center San Antonio
4 Previous Clinical Trials
209 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My liver function is moderately to mildly impaired.My psoriasis is under control and monitored by a specialist.I have brain metastases but no symptoms and haven't taken corticosteroids for a week.I cannot take pills by mouth due to stomach or intestine problems.I have macular degeneration or untreated diabetic eye disease.I am not taking any seizure medications that affect enzyme levels.If I become pregnant or suspect it during the study, I will inform my doctor. I understand I must stop breastfeeding if treated with sorafenib.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I agree to use two forms of birth control if I'm a woman not in menopause or surgically sterile, or a barrier method if I'm a man.I have signed the consent form and understand the study procedures.My liver cancer is confirmed and advanced or has spread.My recent blood tests meet the study's health requirements.I am 18 years old or older.I am fully active or can carry out light work.I cannot undergo surgery or transplantation to cure my condition.I have had local therapy like TACE before.I haven't had systemic therapy or chemotherapy, but local treatments are okay.I am not pregnant and agree to use birth control during the study.I have previously been treated with hydroxychloroquine.I've been on sorafenib for 4+ weeks and my cancer has worsened, as shown on scans.
Research Study Groups:
This trial has the following groups:- Group 1: Progress on sorafenib
- Group 2: No prior systemic treatment
Awards:
This trial has 3 awards, including:- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elaborate on the prior research conducted surrounding Sorafenib (SOR)?
"At present, there are 122 active Sorafenib (SOR) clinical trials taking place; 28 of which are in the advanced Phase 3 stage. Primarily based in Taibei, Taiwan, these studies have also extended to a total of 3389 locations across the globe."
Answered by AI
What diseases has SOR been successfully employed in treating?
"Patients suffering from hemangiosarcoma, malaria, and sjögren's syndrome may find relief in Sorafenib (SOR)."
Answered by AI
Are there still opportunities to participate in this research endeavor?
"Affirmative. According to the clinicaltrials.gov database, this research endeavour is actively seeking participants as of September 16th 2022- 68 recruits are being sought from a single study site since its inception on February 16th 2017."
Answered by AI
How many participants are being welcomed into this medical research project?
"Affirmative. Data located on clinicaltrials.gov verifies that this medical experiment, which was initially shared on February 16th 2017, is actively seeking volunteers. Approximately 68 individuals need to be enlisted from 1 research facility."
Answered by AI
Has Sorafenib (SOR) been sanctioned by the FDA?
"Sorafenib has been assigned a rating of 2 on our assessment scale due to the existing evidence of its safety, but lack thereof regarding its efficacy. This is in line with it being classified as a Phase 2 trial."
Answered by AI
Does the current research protocol permit individuals over 25 to participate?
"This medical trial is open to participants aged 18 and over, up until the age of 100."
Answered by AI
Who meets the eligibility requirements for this research trial?
"To be a potential candidate for this clinical trial, participants must have been diagnosed with carcinoma or hepatocellular and they should fall within the ages of 18 to 100. A total of 68 enrolments are currently being sought after."
Answered by AI
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