RecruitingPhase 4NCT05124002

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

Recombinant Human Adenovirus Type 5 Combined With Hepatic Artery Infusion Chemotherapy of FOLFOX in Patients With Intrahepatic Mass-forming Cholangiocarcinoma: a Single-site, Single-arm, Prospective Study


Sponsor

Beijing Tsinghua Chang Gung Hospital

Enrollment

66 participants

Start Date

Aug 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Oncolytic viruses can selectively replicate in and destroy tumor cells. Recent studies indicate that recombinant human adenovirus type 5 (H101), which is the first approved oncolytic virus drug in the world, shows anti-tumor effects on liver cancer. This study aims to further verify the effect and safety of recombinant human adenovirus type 5 combined with HAIC in the treatment of intrahepatic mass-forming cholangiocarcinoma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two treatments — a gene therapy virus (recombinant adenovirus type 5) injected into the tumor and a chemotherapy infusion delivered directly into the liver arteries (HAIC-FOLFOX) — for people with intrahepatic cholangiocarcinoma, a type of liver bile duct cancer that cannot be surgically removed. The virus is designed to selectively infect and kill cancer cells while boosting immune attack on the tumor. **You may be eligible if...** - You are 18 or older with biopsy-confirmed bile duct cancer inside the liver (intrahepatic mass-forming cholangiocarcinoma) - Your cancer cannot be surgically removed, or you decline surgery - Your cancer has at least one measurable lesion on scans - You have at least 3 months life expectancy - Your organ function (liver, kidneys, blood counts, heart) meets study requirements - You are willing to use contraception if applicable **You may NOT be eligible if...** - Your cancer has spread to areas that make liver-directed treatment ineffective - Your liver function is too poor (e.g., advanced liver failure) - You have a condition that is a contraindication to adenovirus infusion - You have had another anti-cancer treatment within the past 21 days - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRecombinant 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.

DRUGHAIC 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.


Locations(1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, China

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NCT05124002


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