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HAIC Combined With Toripalimab and Donafenib for Advanced BTC

NCT05350943 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2022-10-18

No results posted yet for this study

Summary

This is a single center, single arm, phase II, prospective study to evaluate the efficacy and safety of Hepatic Arterial Infusion Chemotherapy (HAIC) combined with PD-1 inhibitor immunotherapy Toripalimab and Tyrosine Kinase Inhibitor Donafenib in patients with advanced biliary tract cancer.

Conditions

  • Biliary Tract Adenocarcinoma

Interventions

PROCEDURE

HAIC

After successful percutaneous hepatic artery cannulation, superior mesenteric arteriogram and hepatic arteriogram were performed, and after confirming that the subjects were eligible for enrollment according to the results, the hepatic artery was cannulated to the predetermined position. The catheter was connected to a syringe pump in the ward for continuous pumping of drugs.

DRUG

Gemcitabine

1000 mg/m\^2 in 100ml saline solution IV, d1, Q3W

DRUG

Oxaliplatin

85 mg/m\^2 in 500ml 5% glucose solution over 2 hours IV, d1, Q3W

DRUG

Toripalimab

3mg/kg (body weight \< 60kg) or 240 mg（body weight\>= 60kg）in 250 saline soluation, IV, Q3W

DRUG

Donafenib

0.2mg. P.O, BID, continuously

Sponsors & Collaborators

  • Lu Wang, MD, PhD

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-11-30
Completion
2023-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05350943 on ClinicalTrials.gov