TACE With Dicycloplatin(TP21) in Unresectable HCC

NCT05472896 | Unknown Phase 3

• 1 other identifier: TP21-TACE
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; TACE

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to ~1 years

Secondary Outcomes (8)

• Progression-free survival (PFS) by investigator

  Up to ~1 years

• Objective Response Rate (ORR)

  Up to ~1 years

• Disease Control Rate (DCR)

  Up to ~1 years

• Overall Survival (OS)

  Up to ~3 years

• Time To Progress (TTP)

  Up to ~3 years

Other Outcomes (1)

• Adverse event/ serious adverse event

  Up to ~2years

Study Arms (2)

cTACE with TP21

EXPERIMENTAL

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.

Procedure: cTACE; Drug: Dicycloplatin (TP21)

cTACE with epirubicin

ACTIVE COMPARATOR

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.

Procedure: cTACE; Drug: Epirubicin

Interventions

cTACE PROCEDURE

transcatheter arterial chemoembolization with

cTACE with TP21; cTACE with epirubicin

Dicycloplatin (TP21) DRUG

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.

cTACE with TP21

Epirubicin DRUG

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.

cTACE with epirubicin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Gao-jun Teng: lead

Study Sites (1)

Zhongda Hospital, Southeast University

Nanjing, Jiangsu, 210009, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

diammine(1,1-cyclobutanedicarboxylate)platinum(II); Epirubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Gao-Jun Teng, Doctor

  Zhongda Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hai-Dong Zhu Doctor, Doctor

CONTACT

13851420979; zhuhaidong9509@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: an open, parallel-controlled, multicenter randomized trial

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 25, 2022
• Study Start: June 9, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: July 25, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)