TACE With Dicycloplatin(TP21) in Unresectable HCC

• Status: Recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gao-jun Teng
• Treatments: Epirubicin

Criteria

Inclusion Criteria:

1. age 18 years or older, and life expectancy ≥ 3 months;

2. histopathologically or clinically confirmed HCC;

3. Child-Pugh class A or B liver function (≤7 level), Eastern Cooperative Oncology Group performance status (PS) score of 0, 1 or 2；

4. 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.);

5. at least one lesion measurable by modified Response Evaluation Criteria in Solid Tumors for HCC (mRECIST);

6. no history of TACE or tumor recurrence after curative-intent therapy (i.e., surgical resection or ablation);

7. 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:

1. allergic to platinum or iodine products or epirubicin and related excipients;

2. diffuse HCC (whole liver tumor burden ≥ 70%),and the hepatocellular carcinoma is hypovascular;

3. first-order branches and distant of the portal vein tumor thrombus;

4. Liver function classification is Child Pugh C;

5. Invasion of left and right hepatic duct, common hepatic duct, cystic duct and common bile duct;

6. The tumor has severe arteriovenous shunt, which the investigator judges may affect the efficacy of TACE; or there is extrahepatic metastasis;

7. Patients with other tumors, except for thyroid tumors and skin carcinoma in situ that have been cured, early cervical cancer;

8. Have a history of gastrointestinal bleeding or a marked tendency to gastrointestinal bleeding within 6 months before randomization;

9. Uncorrectable abnormal coagulation function or bleeding tendency;

10. 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;

11. received immunotherapy, targeted therapy or radiotherapy for intrahepatic tumors

12. have received an organ transplant