Hepatocellular CarcinomaPhase 1/2NCT02013778
Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC
A Phase 1/2 study testing HCQ in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- HCQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 2019
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient capable of giving informed consent
- Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods (Pathologically confirmed HCC by biopsy or HCC 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced MRI or CT or Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alphafetoprotein (AFP) greater than 200 mg/mL.
- Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania.
- Age 18 years old
- Albumin 2.4 g/dL; Total bilirubin 2 mg/dL; INR 1.5
- Creatinine 2.0 mg/dL, AST 121 IU/L; ALT 189 IU/L
- Child-Turcotte-Pugh Classification A or B
- Eastern Clinical Oncology Group performance status 0 or1.
Who cannot join
- Prior TACE
- Active GI hemorrhage within 2 weeks of study enrollment
- Ascites refractory to medical therapy
- Contraindication to receiving HCQ or TACE
- Unilobar HCC
- Contraindication to contrast enhanced MRI (i.e. unable to undergo follow-up imaging)
- Women who are pregnant
- Participation in another concurrent treatment protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase I-II Clinical Trial of the Safety and Preliminary Efficacy of Hydroxychloroquine Combined With Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma
Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- HCQ
- Keywords
- outside of transplant criteria
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HCQDrug
| Study group | Role | What they receive |
|---|---|---|
| TACE + HCQ | Experimental | Subjects will receive HCQ plus standard of care TACE. Receives: Drug: HCQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2018
- Study completionFeb 2019
Why it stopped: Lack of enrollment
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 CarcinomaStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gregory Nadolski, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013778
- Sponsor's protocol ID
- UPCC 22213
- Status last verified
- Apr 2020
- First submitted
- 12 Dec 2013
- Last updated
- 20 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I-II Clinical Trial of the Safety and Preliminary Efficacy of Hydroxychloroquine Combined With Transarterial Chemoembolization in Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02013778
- Acronym / sponsor ID
- UPCC 22213
- Conditions
- Hepatocellular Carcinoma
- Keywords
- outside of transplant criteria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 17 Dec 2013 (estimated)
- Results
- Posted 20 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Phase I:To determine dose limiting toxicities and maximum tolerated dose (MTD) of the oral administration of hydroxychloroquine (HCQ) in conjunction with transarterial chemoembolization (TACE) in treating hepatocellular carcinoma (HCC). A conventional 3+3 design will be utilized. Primary Phase II: To evaluate the complete response rate in a cohort of patients treated at the MTD, A Simon's Optimal Two-stage design will be utilized.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TACE + HCQ | Experimental | Drug: HCQSubjects will receive HCQ plus standard of care TACE. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient capable of giving informed consent
- Patient diagnosed with hepatocellular carcinoma in both lobes of the liver by one of the following methods (Pathologically confirmed HCC by biopsy or HCC 2 cm with classic radiographic findings of arterial phase enhancement with venous phase washout and pseudocapsule formation on contrast enhanced MRI or CT or Lesion greater than 2 cm with probable imaging features of HCC and imaging findings of cirrhosis and/or portal hypertension or a serum alphafetoprotein (AFP) greater than 200 mg/mL.
- Patient not candidate for orthotopic liver transplantation at the Hospital of the University of Pennsylvania based on review of patient imaging and history at multidisciplinary Hepatic Tumor Conference at the Hospital of the University of Pennsylvania.
- Age 18 years old
- Albumin 2.4 g/dL; Total bilirubin 2 mg/dL; INR 1.5
Key exclusion criteria (8 listed)
- Prior TACE
- Active GI hemorrhage within 2 weeks of study enrollment
- Ascites refractory to medical therapy
- Contraindication to receiving HCQ or TACE
- Unilobar HCC
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 |
|---|---|---|
| HCQ | Drug | TACE + HCQ |
Primary outcome
Number of Participants With Adverse Events
Time frame: 1 year
Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- 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.
Gregory Nadolski, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HCQ in people with Hepatocellular Carcinoma, run by Abramson Cancer Center at Penn Medicine 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 8 inclusion and 8 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: stopped early, as of the sponsor's last update on 20 Apr 2020. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 20 Apr 2020). 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?
Number of Participants With Adverse Events (time frame: 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 20 Apr 2020.