Ignite Creation Date:
2024-05-06 @ 5:53 PM
Last Modification Date:
2024-10-26 @ 2:37 PM
Study NCT ID:
NCT05472896
Status:
UNKNOWN
Last Update Posted:
2022-07-25
First Post:
2022-07-22
Brief Title:
TACE With DicycloplatinTP21 in Unresectable HCC
Sponsor:
Gao-jun Teng
Organization:
Zhongda Hospital
Study Overview
Official Title:
TACE With DicycloplatinTP21 in Patients With Unresectable Hepatocellular Carcinoma an Open Parallel-controlledMulticenter Randomized Phase III Trial
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma
1 Primary efficacy endpoint progression-free survival PFS which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors mRECIST
2 Secondary efficacy endpoints PFS objective response rate ORR disease control rate DCR overall survival OS time to progression TTP 1-year progression-free survival 1-year survival and 2-year survival assessed by the investigator
1 Primary efficacy endpoint progression-free survival PFS which will be assessed by the Independent Review Committee according to the modified Response Evaluation Criteria in Solid Tumors mRECIST
2 Secondary efficacy endpoints PFS objective response rate ORR disease control rate DCR overall survival OS time to progression TTP 1-year progression-free survival 1-year survival and 2-year survival assessed by the investigator
Detailed Description:
TP21 injection is a supramolecular compound that has completed early pharmacological and toxicological preclinical studies as well as phase I and II clinical studies Data from previous studies showed that TP21 injection has significant advantages over traditional platinum-based drugs in terms of broad spectrum low toxicity high efficacy and low drug resistance etc The results of the Phase II TACE clinical exploratory study in hepatocellular carcinoma showed a trend for TP21 alone to be significantly better than epirubicin alone and due to the small sample size the available data were insufficient to demonstrate obvious advantage of this drug Now a confirmatory phase III clinical study of TACE for hepatocellular carcinoma is needed which may continue to adopt the main design of the phase II clinical trial in a single agent comparison form all the subjects will be randomized 11 into TP21lipiodol group trial group and epirubicin hydrochloridelipiodol group control group to receive TACE treatment of either TP21lipiodol or epirubicin hydrochloridelipiodol TACE treatment should be carried out for no more than 3 times in half a year to no more than 5 times within 1 year and about 332 subjects will be enrolled 166 for the trial group and the control group each
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None