Hepatocellular Carcinoma
Conditions
Keywords
outside of transplant criteria
Brief 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. 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.
Interventions
DRUGHCQ
Sponsors
Abramson Cancer Center at Penn Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 1 year | Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TACE + HCQ Subjects will receive HCQ plus standard of care TACE.
HCQ | 8 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 4 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | TACE + HCQ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Bilobar Hepatocellular Cancer (HCC) | 8 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Sex: Female, Male Female | 1 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 7 / 8 |
| other Total, other adverse events | 2 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Number of Participants With Adverse Events
Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0
Time frame: 1 year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TACE + HCQ | Number of Participants With Adverse Events | 2 Participants |