Hepatocellular CancerPhase 2NCT03037437
Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer
A Phase 2 study testing Sorafenib (SOR) and Hydroxychloroquine (HCQ) in people with Hepatocellular Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ would lead to disease stability in patients with advanced hepatocellular cancer (HCC). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- Sorafenib (SOR) and Hydroxychloroquine (HCQ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Feb 2017to 27 Jun 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cytologically or histologically confirmed advanced or metastatic HCC. If no histological diagnosis, patient must have imaging studies compatible with HCC.
- Age 18 years and above
- ECOG performance status of 0 or 1
- Not a candidate for curative treatments (i.e., resection, transplantation)
- Child-Pugh class A or B7 liver function
- Measurable disease as defined by RECIST 1.1
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- Patients who received prior local therapy (e.g., TACE) are eligible.
- Documented virology status of hepatitis, as confirmed by screening HBsAg, anti-HBc, and/or anti-HCV
- Life expectancy> 3 months
- For women who are not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus): agreement to use two adequate methods of contraception. For men: agreement to use a barrier method of contraception during the treatment period
- Hematologic, Biochemical, and Organ Function within 7 days prior to Cycle 1 Day 1: Granulocyte count > 1500/mm3, Platelet count > 75,000/ mm3, Hemoglobin > 8 g/dL; Total bilirubin < 2.0; Albumin > 2.8g/dl; AST (SGOT) and ALT (SGPT) < 5 x ULN; Serum creatinine< 1.5 x ULN
- Cohort 1 (with sorafenib): No previous systemic therapy including sorafenib or chemotherapy treatment. Previous TACE and local treatments are permitted.
- Cohort 2 (on progression of sorafenib): Patients who have received prior sorafenib therapy for at least 4 weeks and has confirmation of disease progression on CT/MRI. Prior surgery or local therapy within 4 weeks prior to Cycle 1 Day 1, with the exception of palliative radiation therapy to the bone
Who cannot join
- Patients receiving prior therapy with HCQ.
- Patients with uncontrolled brain metastases. Patients with brain metastases must be asymptomatic and off corticosteroids for at least one week.
- Due to risk of disease exacerbation, patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
- Patients with previously documented macular degeneration or or untreated diabetic retinopathy (stable retinopathy is allowed).
- Patients may not be receiving any other investigational agents.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to HCQ.
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- Patients requiring the use of enzyme-inducing anti-epileptic medication (phenytoin, carbamazepine, phenobarbital, primidone or oxcarbazepine) are not eligible for entry into the study.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- QTc > 500 milliseconds (ms) at baseline.
- Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease. Patients with NG-tube, J-tube, or G-tube will not be allowed to participate.
- Pregnant women are excluded from this study because sorafenib has the potential for teratogenic or abortifacient effects. For this reason, women of childbearing potential and men must also agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation.
- Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sorafenib, breastfeeding should be discontinued.
- Informed Consent - No study specific procedures will be performed without a written and signed informed consent document. Patients who do not demonstrate the ability to understand or the willingness to sign the written informed consent document will be excluded from study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Cancer Center
San Antonio, Texas, 78229
About this study
Official title: Modulation of Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer
The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ would lead to disease stability in patients with advanced hepatocellular cancer (HCC).
Read the detailed description
Phase 2 study with two cohorts:
Cohort 1: As second-line treatment, we will add HCQ to SOR dose the patient was tolerating at the time of progression.
Cohort 2: SOR-naïve patients receive SOR 400 mg by PO twice daily on Cycle1 Day1 (C1D1). On Cycle 1 Day 15, HCQ 400 mg PO daily will be started. In clinical practice, dose reduction of SOR may be required. On C1D15 SOR maybe kept as starting dose or reduced for toxicity. On Cycle 2 Day 1 of toxicity of HCQ and SOR will be assessed.
Each cycle is 28 days.
Blood samples will be collected at Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 to assess for biomarkers.
Disease evaluation every 2 cycles.
Dose reductions due to adverse events are allowed for both sorafenib per standard of care and/or HCQ for grade 3 or more adverse event was related to study medication. Dose reductions are also permitted based on investigator clinical decision.
- Conditions
- Hepatocellular Cancer
- Being tested
- Sorafenib (SOR), Hydroxychloroquine (HCQ)
- Keywords
- Hepatocellular Cancer, Sorafenib, Hydroxychloroquine
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorafenib (SOR)Drug
Also called Nexavar
Patients will receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1).
Hydroxychloroquine (HCQ)Drug
Also called Plaquenil
400mg by mouth daily
| Study group | Role | What they receive |
|---|---|---|
| No prior systemic treatment | Experimental | 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. Receives: Drug: Sorafenib (SOR); Drug: Hydroxychloroquine (HCQ) |
| Progress on sorafenib | Experimental | As second-line treatment, we will add hydroxychloroquine (HCQ) to sorafenib (SOR) dose the patient was tolerating at the time of progression. Receives: Drug: Sorafenib (SOR); Drug: Hydroxychloroquine (HCQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Tumor Progression Evaluated Via Tumor Imaging
Computerized axial tomography (CAT) Scan or Magnetic resonance imaging (MRI) will be done at Screening, then every other cycle and evaluated using RECIST version 1.1
Measured: From baseline to study completion, approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start16 Feb 2017
- Primary completion27 Jun 2025
- Study completion27 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukeshi Patel, The University of Texas Health Science Center at San Antonio
- Investigators
- Sukeshi Patel Arora, MD, Principal investigator, Cancer Therapy & Research Center University of Texas Health Science Center San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03037437
- Sponsor's protocol ID
- CTMS 16-0076
- Other IDs
- HSC20160515H
- Status last verified
- Jun 2026
- First submitted
- 19 Jan 2017
- Last updated
- 21 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Sorafenib Induced Autophagy Using Hydroxychloroquine in Hepatocellular Cancer
- ClinicalTrials.gov ID
- NCT03037437
- Acronym / sponsor ID
- CTMS 16-0076
- Conditions
- Hepatocellular Cancer
- Keywords
- Hepatocellular Cancer, Sorafenib, Hydroxychloroquine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 16 Feb 2017 (actual)
- Primary completion
- 27 Jun 2025 (actual)
- Study completion
- 27 Jun 2025 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 21 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PI is studying if sorafenib/hydroxychloroquine (HCQ) will have improved efficacy when compared to sorafenib alone and in patients progressing of sorafenib the addition of HCQ would lead to disease stability in patients with advanced hepatocellular cancer (HCC).
Detailed description
Phase 2 study with two cohorts:
Cohort 1: As second-line treatment, we will add HCQ to SOR dose the patient was tolerating at the time of progression.
Cohort 2: SOR-naïve patients receive SOR 400 mg by PO twice daily on Cycle1 Day1 (C1D1). On Cycle 1 Day 15, HCQ 400 mg PO daily will be started. In clinical practice, dose reduction of SOR may be required. On C1D15 SOR maybe kept as starting dose or reduced for toxicity. On Cycle 2 Day 1 of toxicity of HCQ and SOR will be assessed.
Each cycle is 28 days.
Blood samples will be collected at Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 2 Day 1 to assess for biomarkers.
Disease evaluation every 2 cycles.
Dose reductions due to adverse events are allowed for both sorafenib per standard of care and/or HCQ for grade 3 or more adverse event was related to study medication. Dose reductions are also permitted based on investigator clinical decision.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No prior systemic treatment | Experimental | Drug: Sorafenib (SOR), Drug: Hydroxychloroquine (HCQ)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. |
| Progress on sorafenib | Experimental | Drug: Sorafenib (SOR), Drug: Hydroxychloroquine (HCQ)As second-line treatment, we will add hydroxychloroquine (HCQ) to sorafenib (SOR) dose the patient was tolerating at the time of progression. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Cytologically or histologically confirmed advanced or metastatic HCC. If no histological diagnosis, patient must have imaging studies compatible with HCC.
- Age 18 years and above
- ECOG performance status of 0 or 1
- Not a candidate for curative treatments (i.e., resection, transplantation)
- Child-Pugh class A or B7 liver function
Key exclusion criteria (13 listed)
- Patients receiving prior therapy with HCQ.
- Patients with uncontrolled brain metastases. Patients with brain metastases must be asymptomatic and off corticosteroids for at least one week.
- Due to risk of disease exacerbation, patients with psoriasis are ineligible unless the disease is well controlled, and they are under the care of a specialist for the disorder who agrees to monitor the patient for exacerbations.
- Patients with previously documented macular degeneration or or untreated diabetic retinopathy (stable retinopathy is allowed).
- Patients may not be receiving any other investigational agents.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorafenib (SOR)Also: NexavarPatients will receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1). | Drug | No prior systemic treatment, Progress on sorafenib |
| Hydroxychloroquine (HCQ)Also: Plaquenil400mg by mouth daily | Drug | No prior systemic treatment, Progress on sorafenib |
Primary outcome
Time to Tumor Progression Evaluated Via Tumor Imaging
Time frame: From baseline to study completion, approximately 1 year
Computerized axial tomography (CAT) Scan or Magnetic resonance imaging (MRI) will be done at Screening, then every other cycle and evaluated using RECIST version 1.1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sukeshi Patel Arora, MD principal investigator
Cancer Therapy & Research Center University of Texas Health Science Center San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sorafenib (SOR) and Hydroxychloroquine (HCQ) in people with Hepatocellular Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Tumor Progression Evaluated Via Tumor Imaging (time frame: From baseline to study completion, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.