HAIC Combined With Toripalimab and Donafenib for Advanced BTC

NCT05350943 | Unknown Phase 2

• 1 other identifier: 2021-GZWK-04
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  the sum of complete response rate and partial response rate

  through study completion, an average of 2 year

Secondary Outcomes (5)

• Disease Control rate (DCR)

  through study completion, an average of 2 year

• Progression-free survival (PFS)

  through study completion, an average of 2 year

• Overall survival (OS)

  through study completion, an average of 2 year

• Number of participants with treatment-related adverse events as assessed by NCI CTCAE v4.0.

  through study completion, an average of 2 year

• Quality of life questionnaire

  through study completion, an average of 2 year

Study Arms (1)

HAIC+Toripalimab+Donafenib

EXPERIMENTAL

HAIC(GEMOX)+Toripalimab+Donafenib

Procedure: HAIC; Drug: Gemcitabine; Drug: Oxaliplatin; Drug: Toripalimab; Drug: Donafenib

Interventions

HAIC PROCEDURE

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.

HAIC+Toripalimab+Donafenib

Gemcitabine DRUG

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

HAIC+Toripalimab+Donafenib

Oxaliplatin DRUG

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

HAIC+Toripalimab+Donafenib

Toripalimab DRUG

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

HAIC+Toripalimab+Donafenib

Donafenib DRUG

0.2mg. P.O, BID, continuously

HAIC+Toripalimab+Donafenib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age, of any sex;
• Histologically/Cytologically confirmed diagnosis of unresectable advanced adenocarcinoma of the gallbladder, intrahepatic bile duct and extrahepatic bile duct.
• At least one measurable lesion umder CT/MRI as defined by RECIST1.1 criteria
• Patients must have adequate organ and marrow function as defined below:
• Blood test:
• Hemoglobin (HB) ≥90 g/L Absolute neutrophil count (ANC) ≥1.5×10\^9/L； Platelet (PLT) ≥80×10\^9/L；
• Biochemical test:
• total bilirubin≤2×ULN (institutional upper limit of norm) AST(SGOT)/ALT(SGPT)≤2.5 ×ULN creatinine clearance≥ 50 ml/min as calculated by the Cockroft-Gault formula
• Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-1;
• Indocyanine Green Retention Rates at 15 min (ICGR15\<22%;
• Life expectancy of \> 3 months;

You may not qualify if:

• Patients with other malignant tumors should be excluded
• Female patients who are pregnant or breast-feeding. Female patients who are pregnant during the study should also exit.
• Patient has enter any other clinical trails within 4 weeks prior to study entry.
• Patient known with a severe and/or uncontrolled medical disease.
• Chronic non-healing wound/bone fracture
• History of organ transplant
• Patients with abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), those have bleeding tendency (14 days prior to randomization must meet: INR is within the normal range without any use of anticoagulants); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or analogous therapy; use for preventive purposes is permitted provided that the international normalized ratio of prothrombin time (INR) ≤ 1.5, take low-dose warfarin (1 mg PO, QD) or low-dose aspirin (do not exceed 100 mg per day);
• Previous history of aterial/venous thrombosis such as cerebrovascular accidents, pulmonary embolism or deep venous thrombosis within one year prior to patients recruitment.
• Hitstory of psychiatric drug abuse and hasn't come clean, or with psychiatric illness/social situations that would limit compliance with study requirements
• History of immunodeficiency, or other acquired/congenital immunodeficiency diseases
• Concomitant diseases that severely endanger the safety of the subject or affect the study completion according to the judgment of the investigator
• Willingness to sign a written informed consent document, with good compliance.

Sponsors & Collaborators

• Lu Wang, MD, PhD: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200062, China

Location

MeSH Terms

Interventions

Gemcitabine; Oxaliplatin; toripalimab; donafenib

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 28, 2022
• Study Start: March 1, 2022
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10

Locations

CN (1)