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TACE With Dicycloplatin(TP21) in Unresectable HCC

Primary Purpose

Hepatocellular Carcinoma

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

cTACE

Dicycloplatin (TP21)

Epirubicin

About this trial

This is an interventional treatment trial for Hepatocellular Carcinoma focused on measuring Hepatocellular Carcinoma, TACE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

age 18 years or older, and life expectancy ≥ 3 months;
histopathologically or clinically confirmed HCC;
Child-Pugh class A or B liver function (≤7 level), Eastern Cooperative Oncology Group performance status (PS) score of 0, 1 or 2；
China Liver Cancer stage IIb, IIIa (only Cheng's classification type I:portal vein tumor thrombus invading the portal vein branches of the liver lobe or liver segment) , and Ib, 2a patients who can be surgically removed, but are unable or unwilling to undergo surgery due to other reasons (such as advanced age, severe liver cirrhosis, etc.);
at least one lesion measurable by modified Response Evaluation Criteria in Solid Tumors for HCC (mRECIST);
no history of TACE or tumor recurrence after curative-intent therapy (i.e., surgical resection or ablation);
No blood transfusion and blood products, no use of granulocyte colony-stimulating factor (GCSF) and other hematopoietic stimulating factors within 2 weeks before screening; Hemoglobin ≥ 80g/L；Platelet count ≥ 60×10^9 /L; White blood cell count ≥ 3×10^9/L; Alanine aminotransferase ≤ 3 times the upper limit of normal; Aspartate aminotransferase ≤ 3×times the upper limit of normal; Serum creatinine Cr ≤ 1.5×times the upper limit of normal;

Exclusion Criteria:

allergic to platinum or iodine products or epirubicin and related excipients;
diffuse HCC (whole liver tumor burden ≥ 70%),and the hepatocellular carcinoma is hypovascular;
first-order branches and distant of the portal vein tumor thrombus;
Liver function classification is Child Pugh C;
Invasion of left and right hepatic duct, common hepatic duct, cystic duct and common bile duct;
The tumor has severe arteriovenous shunt, which the investigator judges may affect the efficacy of TACE; or there is extrahepatic metastasis;
Patients with other tumors, except for thyroid tumors and skin carcinoma in situ that have been cured, early cervical cancer;
Have a history of gastrointestinal bleeding or a marked tendency to gastrointestinal bleeding within 6 months before randomization;
Uncorrectable abnormal coagulation function or bleeding tendency;
received other antitumor therapies within the past 4 weeks (e.g., chemotherapy, radiotherapy, immunotherapy,Chinese medicine with antitumor effect), or received the above anti-tumor drugs within 5 half-lives;
received immunotherapy, targeted therapy or radiotherapy for intrahepatic tumors
have received an organ transplant

Sites / Locations

Zhongda Hospital, Southeast UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

cTACE with TP21

cTACE with epirubicin

Arm Description

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.

Outcomes

Primary Outcome Measures

Progression-free survival (PFS) by Independent Review Committee

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

Secondary Outcome Measures

Progression-free survival (PFS) by investigator

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

Objective Response Rate (ORR)

Disease Control Rate (DCR)

Overall Survival (OS)

Time To Progress (TTP)

1 year progression-free survival rate

1 year survival rate

2 year survival rate

Full Information

NCT ID

NCT05472896

First Posted

July 22, 2022

Last Updated

July 22, 2022

Sponsor

Gao-jun Teng

1. Study Identification

Unique Protocol Identification Number

NCT05472896

Brief Title

TACE With Dicycloplatin(TP21) in Unresectable HCC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 9, 2022 (Actual)

Primary Completion Date

June 30, 2024 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Gao-jun Teng

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the effectiveness and safety of TP21 injection for TACE in treatment of hepatocellular carcinoma: 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). 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma, TACE

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

an open, parallel-controlled, multicenter randomized trial

Masking

Outcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

cTACE with TP21

Arm Type

Experimental

Arm Description

Arm Title

cTACE with epirubicin

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

cTACE

Intervention Description

transcatheter arterial chemoembolization with

Intervention Type

Drug

Intervention Name(s)

Dicycloplatin (TP21)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Epirubicin

Intervention Description

Primary Outcome Measure Information:

Title

Progression-free survival (PFS) by Independent Review Committee

Description

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

Time Frame

Up to ~1 years

Secondary Outcome Measure Information:

Title

Progression-free survival (PFS) by investigator

Description

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

Time Frame

Up to ~1 years

Title

Objective Response Rate (ORR)

Time Frame

Up to ~1 years

Title

Disease Control Rate (DCR)

Time Frame

Up to ~1 years

Title

Overall Survival (OS)

Time Frame

Up to ~3 years

Title

Time To Progress (TTP)

Time Frame

Up to ~3 years

Title

1 year progression-free survival rate

Time Frame

Up to ~1 years

Title

1 year survival rate

Time Frame

Up to ~1 years

Title

2 year survival rate

Time Frame

Up to ~2years

Other Pre-specified Outcome Measures:

Title

Adverse event/ serious adverse event

Time Frame

Up to ~2years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 18 years or older, and life expectancy ≥ 3 months; histopathologically or clinically confirmed HCC; Child-Pugh class A or B liver function (≤7 level), Eastern Cooperative Oncology Group performance status (PS) score of 0, 1 or 2； China Liver Cancer stage IIb, IIIa (only Cheng's classification type I:portal vein tumor thrombus invading the portal vein branches of the liver lobe or liver segment) , and Ib, 2a patients who can be surgically removed, but are unable or unwilling to undergo surgery due to other reasons (such as advanced age, severe liver cirrhosis, etc.); at least one lesion measurable by modified Response Evaluation Criteria in Solid Tumors for HCC (mRECIST); no history of TACE or tumor recurrence after curative-intent therapy (i.e., surgical resection or ablation); No blood transfusion and blood products, no use of granulocyte colony-stimulating factor (GCSF) and other hematopoietic stimulating factors within 2 weeks before screening; Hemoglobin ≥ 80g/L；Platelet count ≥ 60×10^9 /L; White blood cell count ≥ 3×10^9/L; Alanine aminotransferase ≤ 3 times the upper limit of normal; Aspartate aminotransferase ≤ 3×times the upper limit of normal; Serum creatinine Cr ≤ 1.5×times the upper limit of normal; Exclusion Criteria: allergic to platinum or iodine products or epirubicin and related excipients; diffuse HCC (whole liver tumor burden ≥ 70%),and the hepatocellular carcinoma is hypovascular; first-order branches and distant of the portal vein tumor thrombus; Liver function classification is Child Pugh C; Invasion of left and right hepatic duct, common hepatic duct, cystic duct and common bile duct; The tumor has severe arteriovenous shunt, which the investigator judges may affect the efficacy of TACE; or there is extrahepatic metastasis; Patients with other tumors, except for thyroid tumors and skin carcinoma in situ that have been cured, early cervical cancer; Have a history of gastrointestinal bleeding or a marked tendency to gastrointestinal bleeding within 6 months before randomization; Uncorrectable abnormal coagulation function or bleeding tendency; received other antitumor therapies within the past 4 weeks (e.g., chemotherapy, radiotherapy, immunotherapy,Chinese medicine with antitumor effect), or received the above anti-tumor drugs within 5 half-lives; received immunotherapy, targeted therapy or radiotherapy for intrahepatic tumors have received an organ transplant

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Hai-Dong Zhu Doctor, Doctor

Phone

13851420979

zhuhaidong9509@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gao-Jun Teng, Doctor

Organizational Affiliation

Zhongda Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Zhongda Hospital, Southeast University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210009

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hai-Dong Zhu

Phone

86-25-83262224

zhuhaidong9509@163.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

TACE With Dicycloplatin(TP21) in Unresectable HCC

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