Safety and efficacy of RX108 delivered via drug eluting beads transarterial chemoembolization (DEB-TACE) in patients with primary hepatocellular carcinoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100052066

Enrollment

Unknown

Registered

2021-10-16

Start date

2021-10-01

Completion date

Unknown

Last updated

2022-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary hepatocellular carcinoma

Interventions

Primary hepatocellular carcinoma group:RX108 delivered via drug eluting beads transarterial chemoembolization (DEB-TACE)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Written informed consent; 2. Primary hepatocellular carcinoma has been confirmed by histopathology and/or cytology, or diagnosed clinically and has not been treated with TACE (i.e., DEB-TACE and cTACE); 3. At least one measurable tumor lesion according to mRICIST and in the stage of II or IIIA based on CNLC as well as having the suitable indications for receiving TACE treatment; 4. At least 6 month expected period of survival time; 5. ECOG score 0-2; 6. Child-Pugh Score A or B(7); 7. Adequate hematologic, hepatic and renal function; 8. Must agree to use adequate contraception (females and males).

Exclusion criteria

Exclusion criteria: 1. Not suitable for undergoing TACE; 2. Bile duct invasion; 3. Prior systemic chemotherapy and other antitumor treatments within 4 weeks before the first TACE treatment; 4. Diffuse hepatocellular carcinoma and primary hepatocellular carcinoma without blood supply; 5. Extrahepatic metastasis; 6. Portal vein main, inferior vena cava tumor thrombus or arteriovenous fistula; 7. Uncorrectable abnormal coagulation function; 8. History of certain cardiac abnormalities; 9. Treatment with prohibited medications; 10. Known contra-indication to digoxin; 11. Clinically significant active infection requiring systemic antibiotic treatment; 12. History of immunodeficiency; 13. With positive result of HIV antibody test; 14. Active hepatitis B; Hepatitis C virus infection (HCV-Ab and HCV -RNA positive) and active syphilis infection; 15. Allergic to drug loaded microspheres and related excipient products; 16. Investigational therapy within 3 months of trial entry.

Design outcomes

Primary

Measure	Time frame
ORR(Objective Response Rate);	—

Secondary

Measure	Time frame
DCR(Disease Control Rate);TTUP(time to untreatable transarterial chemoembolization progression);1-year survival rate;	—

Countries

China

Contacts

Public ContactMeng Zhiqiang

Fudan University Shanghai Cancer Center

mengshca@fudan.edu.cn+86 21 64175590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026