NCT06572189

The Safety and Efficacy of CD-801 in Patients With Advanced Intrahepatic Cholangiocarcinoma

The Safety and Efficacy of Transarterial Injection of CD-801 in Patients With Advanced Intrahepatic Cholangiocarcinoma

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Shanghai Changzheng Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn about the safety of CD-801, a lipid nanoparticle-encapsulated self-replicating RNA encoding hepatocyte nuclear factor 4α (HNF4α) in treating patients with advanced intrahepatic cholangiocarcinoma (ICC). It will also learn if CD-801 works to treat advanced ICC. The main questions it aims to answer are: 1. What medical problems do participants have when injecting CD-801? 2. Is CD-801 effective for ICC patients according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or modified RECIST (mRECIST) Participants will: Receive administration of 100μg of CD-801 via hepatic arterial injection every 14 ± 3 days (the dosing interval will be adjusted based on the tolerability, safety, and therapeutic effect of the subjects), for one treatment cycle. Treatment will continue until the occurrence of disease progression, death, intolerable toxicity, voluntary withdrawal of informed consent, loss to follow-up, initiation of new antitumor treatment, or termination of the study by the investigator (whichever comes first), and completion of the final follow-up and assessment 14 days after the last administration.

Conditions

• Intrahepatic Cholangiocarcinoma

Interventions

Type	Name	Description
GENETIC	Injection of CD-801, a lipid nanoparticle-encapsulated self-replicating RNA encoding hepatocyte nuclear factor 4α (HNF4α)	Receive administration of 100μg of CD-801 via hepatic arterial injection every 14 ± 3 days (the dosing interval will be adjusted based on the tolerability, safety, and therapeutic effect of the subjects), for one treatment cycle. Treatment will continue until the occurrence of disease progression, death, intolerable toxicity, voluntary withdrawal of informed consent, loss to follow-up, initiation of new antitumor treatment, or termination of the study by the investigator (whichever comes first), and completion of the final follow-up and assessment 14 days after the last administration.

Timeline

• Start date: 2024-08-28
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-08-27
• Last updated: 2025-06-29

Locations

1 site across 1 country: China