A Study of PTX-9908 Injection for Non-resectable HCC with TACE

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

October 6, 2020

Primary Completion Date

August 30, 2026

Study Completion Date

December 30, 2026

Conditions
Carcinoma, Hepatocellular
Interventions
DRUG

PTX-9908 Injection

"Proposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg.~Frequency:~Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).~Duration: 4 weeks (Phase I) and 12 weeks (Phase II)."

DRUG

Placebo

"water for injection~Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).~Duration: 12 weeks (Phase II)"

Trial Locations (1)

10002

RECRUITING

National Taiwan University Hospital, New Taipei City

All Listed Sponsors
lead

TCM Biotech International Corp.

INDUSTRY