Could a malaria drug help fight liver cancer?
NCT ID NCT03037437
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether adding hydroxychloroquine (a malaria drug) to the standard cancer drug sorafenib could slow tumor growth in people with advanced liver cancer. 64 adults who were not candidates for surgery or transplant took part. The goal was to see if the combination delayed cancer progression better than sorafenib alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sorafenib and hydroxychloroquine
- What this could lead to
- If successful, this combination could slow liver cancer growth better than sorafenib alone, offering a new treatment option for advanced cases.
- What could go wrong
- This is a small, early-phase trial (64 people) with no control group for comparison. The combination may not improve outcomes and could cause additional side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
64 people
The number who actually took part.
- Started
-
Feb 2017
- Finished
-
Jun 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 100 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
University of Texas Health Cancer Center
San Antonio, Texas, 78229, United States
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