Trial Outcomes & Findings for Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC (NCT NCT02013778)

Last Updated: 2020-04-20

Results Overview

Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

1 year

Results posted on

2020-04-20

Participant milestones
Measure	TACE + HCQ Subjects will receive Hydroxychloroquine (HCQ) plus standard of care Transarterial Chemoembolization (TACE).
Overall Study STARTED	8
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	7

Reasons for withdrawal
Measure	TACE + HCQ Subjects will receive Hydroxychloroquine (HCQ) plus standard of care Transarterial Chemoembolization (TACE).
Overall Study Death	4
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1
Overall Study Adverse Event	1

Phase 1-2 Trial HCQ Plus TACE in Unresectable HCC

Baseline characteristics by cohort
Measure	TACE + HCQ n=8 Participants Subjects will receive HCQ plus standard of care TACE. HCQ
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Bilobar Hepatocellular Cancer (HCC)	8 Participants n=5 Participants

Timeframe: 1 year

Adverse Events graded according to the Common Terminology Criteria of Adverse Events (CTCAE) version 4.0

Outcome measures
Measure	TACE + HCQ n=8 Participants Subjects will receive HCQ plus standard of care TACE. HCQ
Number of Participants With Adverse Events	2 Participants

Serious events: 0 serious events

Other events: 2 other events

Deaths: 7 deaths

Adverse event data not reported

Other adverse events
Measure	TACE + HCQ n=8 participants at risk Subjects will receive HCQ plus standard of care TACE. HCQ
General disorders Pain	25.0% 2/8 • Number of events 3 • 1 year All adverse events occurring during the study period (up to 6 months after last dose of HCQ) were recorded. The clinical course of each event was followed until resolution, stabilization, or until it was determined that the study treatment or participation is not the cause. Serious adverse events that were still ongoing at the end of the study period must be followed up to determine the final outcome.

University of Pennsylvania

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