- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05472896
TACE With Dicycloplatin(TP21) in Unresectable HCC
July 22, 2022 updated by: Gao-jun Teng
TACE With Dicycloplatin(TP21) in Patients With Unresectable Hepatocellular Carcinoma: an Open, Parallel-controlled,Multicenter Randomized Phase III Trial
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
332
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hai-Dong Zhu Doctor, Doctor
- Phone Number: 13851420979
- Email: zhuhaidong9509@163.com
Study Locations
-
-
Jiangsu
-
Nanjing, Jiangsu, China, 210009
- Recruiting
- Zhongda Hospital, Southeast University
-
Contact:
- Hai-Dong Zhu
- Phone Number: 86-25-83262224
- Email: zhuhaidong9509@163.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: cTACE with TP21
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.
|
transcatheter arterial chemoembolization with
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.
|
Active Comparator: cTACE with epirubicin
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
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) by Independent Review Committee
Time Frame: Up to ~1 years
|
Progression-free survival (PFS) by Independent Review Committee (IRC) according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
|
Up to ~1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) by investigator
Time Frame: Up to ~1 years
|
Progression-free survival (PFS) by investigator according to the Modified Response Evaluation Criteria in Solid Tumors (mRECIST).
|
Up to ~1 years
|
Objective Response Rate (ORR)
Time Frame: Up to ~1 years
|
Up to ~1 years
|
|
Disease Control Rate (DCR)
Time Frame: Up to ~1 years
|
Up to ~1 years
|
|
Overall Survival (OS)
Time Frame: Up to ~3 years
|
Up to ~3 years
|
|
Time To Progress (TTP)
Time Frame: Up to ~3 years
|
Up to ~3 years
|
|
1 year progression-free survival rate
Time Frame: Up to ~1 years
|
Up to ~1 years
|
|
1 year survival rate
Time Frame: Up to ~1 years
|
Up to ~1 years
|
|
2 year survival rate
Time Frame: Up to ~2years
|
Up to ~2years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse event/ serious adverse event
Time Frame: Up to ~2years
|
Up to ~2years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2022
Primary Completion (Anticipated)
June 30, 2024
Study Completion (Anticipated)
June 30, 2024
Study Registration Dates
First Submitted
July 22, 2022
First Submitted That Met QC Criteria
July 22, 2022
First Posted (Actual)
July 25, 2022
Study Record Updates
Last Update Posted (Actual)
July 25, 2022
Last Update Submitted That Met QC Criteria
July 22, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Liver Neoplasms
- Carcinoma
- Carcinoma, Hepatocellular
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Epirubicin
Other Study ID Numbers
- TP21-TACE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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