Recombinant Human Adenovirus Type 5 Plus HAIC of FOLFOX for Intrahepatic Cholangiocarcinoma

PHASE4RecruitingINTERVENTIONAL
Enrollment

66

Participants

Timeline

Start Date

August 1, 2022

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2026

Conditions
Cholangiocarcinoma, Intrahepatic
Interventions
DRUG

Recombinant Human Adenovirus Type 5

H101 will be intratumorally injected 3 days before HAIC. Dosage of H101: 1 vial (5.0 × 10\^11 vp) if the maximum diameters of lesion ≤ 5 cm, 2 vials (1.0 × 10\^12 vp) if the maximum diameters of lesion ≤ 10 cm, 3 vials (1.5 × 10\^12 vp) if the maximum diameters of lesion is \> 10 cm.

DRUG

HAIC of FOLFOX

Oxaliplatin 50 mg + 5-FU 1.5 g + leucovorin calcium. The infusion will be continued for 2-3 days according to patients' tolerance and tumor conditions. The standard treatment for HAIC consists of 4-6 cycles, with the second cycle being 3 weeks after the end of the first HAIC cycle and the subsequent cycles being 4 weeks after the end of the previous HAIC.

Trial Locations (1)

102218

RECRUITING

Beijing Tsinghua Chang Gung Hospital, Beijing

All Listed Sponsors
lead

Beijing Tsinghua Chang Gung Hospital

OTHER