A Clinical Trial Evaluating the Safety and Efficacy of Intravenous HNF4α srRNA in Treating Advanced ICC Patients

EARLY_PHASE1RecruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

November 7, 2024

Primary Completion Date

May 31, 2026

Study Completion Date

July 31, 2026

Conditions
Intrahepatic Cholangiocarcinoma
Interventions
DRUG

HNF4α srRNA

"HNF4α srRNA will be administered intravenously for the treatment of ICC. The dosing regimen is planned for a second dose 14 ± 3 days post-initial treatment, followed by subsequent treatments every 28 ± 7 days, with adjustments made based on patient tolerance and therapeutic response.~According to Amendment 1, patients who have received at least 4 cycles of HNF4α srRNA therapy and have a tumor assessment of SD (stable disease) or PD (progressive disease) per RECIST v1.1 criteria may, after a comprehensive evaluation by the investigator considering the patient's treatment history and the current safety and efficacy data of HNF4α srRNA, continue HNF4α srRNA at the same dose, or have their dose adjusted, in combination with immunotherapy, targeted therapy, or chemotherapy."

Trial Locations (1)

200003

RECRUITING

Shanghai Changzheng Hospital, Naval Medical University, Shanghai

All Listed Sponsors
lead

Shanghai Changzheng Hospital

OTHER