HAIC Combined With Toripalimab & Donafenib for Advanced BTC

Clinical Trial 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.

See also
	Status	Clinical Trial	Phase
	Active, not recruiting	`NCT01588860` - Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma	N/A
	Not yet recruiting	`NCT04156958` - Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma	Phase 2

See also

Status

Clinical Trial

Phase

Active, not recruiting

NCT01588860 - Mutation Analysis and Copy Number Changes of KRAS and BRAF Gene in Taiwanese Cases of Biliary Tact Adenocarcinoma

N/A

Not yet recruiting

NCT04156958 - Fruquintinib as Second-line Treatment for Advanced/Metastatic Biliary Tract Adenocarcinoma

Phase 2

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05350943
Study type	Interventional
Source	Fudan University
Contact
Status	Enrolling by invitation
Phase	Phase 2
Start date	March 1, 2022
Completion date	November 2023

HAIC Combined With Toripalimab and Donafenib for Advanced BTC

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms