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HAIC Combined With Toripalimab and Donafenib for Advanced BTC

Primary Purpose

Biliary Tract Adenocarcinoma

Status

Enrolling by invitation

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

HAIC

Gemcitabine

Oxaliplatin

Toripalimab

Donafenib

About this trial

This is an interventional treatment trial for Biliary Tract Adenocarcinoma

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

18 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;

Exclusion Criteria

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.

Sites / Locations

Fudan University Shanghai Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HAIC+Toripalimab+Donafenib

Arm Description

HAIC(GEMOX)+Toripalimab+Donafenib

Outcomes

Primary Outcome Measures

Objective response rate (ORR)

the sum of complete response rate and partial response rate

Secondary Outcome Measures

Disease Control rate (DCR)

the sum of complete response rate, partial response rate and stable disease rate

Progression-free survival (PFS)

Time from randomization to disease progression

Overall survival (OS)

Time from randomization to death for any cause

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

Unforeseen medical events occurred when the subjects received drug treatment or research, but there is not necessarily a causal relationship with the drugs used. Severe adverse events

Quality of life questionnaire

The concept of comprehensively evaluating the quality of life

Full Information

NCT ID

NCT05350943

First Posted

March 24, 2022

Last Updated

October 17, 2022

Sponsor

Lu Wang, MD, PhD

1. Study Identification

Unique Protocol Identification Number

NCT05350943

Brief Title

HAIC Combined With Toripalimab and Donafenib for Advanced BTC

Official Title

Phase II Study to Evaluate the Efficacy and Safety of HAIC Combined With Toripalimab and Donafenib in Patients With Advanced Biliary Tract Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Enrolling by invitation

Study Start Date

March 1, 2022 (Actual)

Primary Completion Date

November 2022 (Anticipated)

Study Completion Date

November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Lu Wang, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Biliary Tract Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HAIC+Toripalimab+Donafenib

Arm Type

Experimental

Arm Description

HAIC(GEMOX)+Toripalimab+Donafenib

Intervention Type

Procedure

Intervention Name(s)

HAIC

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Gemcitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Toripalimab

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Donafenib

Intervention Description

0.2mg. P.O, BID, continuously

Primary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

the sum of complete response rate and partial response rate

Time Frame

through study completion, an average of 2 year

Secondary Outcome Measure Information:

Title

Disease Control rate (DCR)

Description

the sum of complete response rate, partial response rate and stable disease rate

Time Frame

through study completion, an average of 2 year

Title

Progression-free survival (PFS)

Description

Time from randomization to disease progression

Time Frame

through study completion, an average of 2 year

Title

Overall survival (OS)

Description

Time from randomization to death for any cause

Time Frame

through study completion, an average of 2 year

Title

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

Description

Unforeseen medical events occurred when the subjects received drug treatment or research, but there is not necessarily a causal relationship with the drugs used. Severe adverse events

Time Frame

through study completion, an average of 2 year

Title

Quality of life questionnaire

Description

The concept of comprehensively evaluating the quality of life

Time Frame

through study completion, an average of 2 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 18 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; Exclusion Criteria 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.

Facility Information:

Facility Name

Fudan University Shanghai Cancer Center

City

Shanghai

ZIP/Postal Code

200062

Country

China

12. IPD Sharing Statement

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HAIC Combined With Toripalimab and Donafenib for Advanced BTC

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