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In experimental groups, the dosage of dicycloplatin (TP21) was based on the body surface area (550 mg/m2) according to previous research. If grade III or above myelosuppression was observed, an adjusted dose of 450 mg/m2 was then considered, or the patient was removed from the group at the investigator's discretion.The volume ratio of lipiodol to dicycloplatin aqueous solution was 1:1.The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. Standardized gelatin sponge particles of 150-350 μm or 350-560 μm in diameter were injected following embolization with ethiodized oil-chemoembolic emulsion.

the dosage of epirubicin was determined according to the tumor size, and the maximum dose was limited to 40 mg. The volume ratio of lipiodol to epirubicin aqueous solution was 2:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL. Standardized gelatin sponge particles of 150-350 μm or 350-560 μm in diameter were injected following embolization with ethiodized oil-chemoembolic emulsion.

transcatheter arterial chemoembolization with

cTACE

the dosage of dicycloplatin was based on the body surface area (550 mg/m2) according to previous research. The volume ratio of lipiodol to dicycloplatin aqueous solution was 1:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL.

Dicycloplatin (TP21)

the dosage of epirubicin was determined according to the tumor size, and the maximum dose was limited to 40 mg. The volume ratio of lipiodol to epirubicin aqueous solution was 2:1. The volume of lipiodol used was calculated by the size and vascularity of the tumor, within 20 mL.

Hai-Dong Zhu Doctor, Doctor

Hai-Dong Zhu

Gao-Jun Teng, Doctor

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.

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 1:1 into TP21+lipiodol group (trial group), and epirubicin hydrochloride+lipiodol group (control group) to receive TACE treatment of either "TP21+lipiodol" or "epirubicin hydrochloride+lipiodol". 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.

an open, parallel-controlled, multicenter randomized trial

the independent review committee (IRC) was used to evaluate the efficacy, and the readers reviewed the imaging data in a blinded state to make efficacy judgments. The following information was blinded to independent readers: subject's name, date of birth, personal information such as subject's initials, date of examination, statistical grouping, name of study unit, lesion selected by study unit for tumor evaluation, study Unit-determined tumor response and imaging reasons.

TACE With Dicycloplatin(TP21) in Unresectable HCC

TACE With Dicycloplatin（TP21） in Patients With Unresectable Hepatocellular Carcinoma: an Open, Parallel-controlled,Multicenter Randomized Phase III Trial

Progression-free survival (PFS) by Independent Review Committee (IRC) according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).

Progression-free survival (PFS) by investigator according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
TACE With Dicycloplatin(TP21) in Unresectable HCC	NCT05472896	Hepatocellular ...	cTACE Dicycloplatin (... Epirubicin	18 Years -	Zhongda Hospital
TACE With Dicycloplatin(TP21) in Unresectable HCC	NCT05472896	Hepatocellular ...	cTACE Dicycloplatin (... Epirubicin	18 Years -	Zhongda Hospital

Spots Global Cancer Trial Database for dicycloplatin (tp21)