To hear about similar clinical trials, please enter your email below
Trial Title:
HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer
NCT ID:
NCT06389500
Condition:
Biliary Tract Cancer
Conditions: Official terms:
Biliary Tract Neoplasms
Lenvatinib
Conditions: Keywords:
Adebrelimab
Hepatic Arterial Infusion Chemotherapy
Lenvatinib
Potentially Resectable Biliary Tract Cancer
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Adebrelimab
Description:
Adebrelimab, IV
Arm group label:
HAIC+Immune-targeted therapy
Other name:
SHR-1316
Intervention type:
Drug
Intervention name:
Lenvatinib
Description:
Lenvatinib, PO
Arm group label:
HAIC+Immune-targeted therapy
Other name:
Lenvatinib Mesilate Capsules
Intervention type:
Procedure
Intervention name:
Hepatic Arterial Infusion Chemotherapy
Description:
GC regimen±5-FU
Arm group label:
HAIC+Immune-targeted therapy
Summary:
This is a single-arm, exploratory, phase II trial to evaluate the efficacy and safety of
hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib for
borderline resectable, locally advanced biliary tract cancer.
Detailed description:
This study plans to recruit 30 patients with borderline resectable, locally advanced
biliary tract cancer who have not received treatment， abserve and evaluate the efficacy
and safety of hepatic arterial infusion chemotherapy combined with adebrelimab and
lenvatinib.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age: 18 to 75 years old, male or female;
2. Biliary tract malignant tumors confirmed by histology or cytology, with measurable
tumor lesions (spiral CT or MR scan ≥10mm, meeting RECIST 1.1 standards);
3. Borderline resectable, locally advanced biliary malignant tumors, including
gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and
distal cholangiocarcinoma;
4. Clinical stage: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma
stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma
stage: IIIA-IV;
5. Expected survival > 3 months;
6. ECOG PS score: 0-1 points;
7. Liver function classification is Child-Pugh ≤7;
8. Never received prior systemic treatment for biliary tract tumors;
9. No peritoneal metastasis or other distant metastasis;
10. Normal function of major organs;
11. Women of childbearing age must have a negative pregnancy test (βHCG) before starting
treatment, and women of childbearing potential and men (who have sexual active with
women of childbearing potential) must agree to effective contraception uninterrupted
for the duration of the treatment and for 6 months after the last therapeutic dose;
12. Patients voluntarily enrolled in the study by signing an informed consent form.
Exclusion Criteria:
1. Patients diagnosed with periampullary cancer;
2. Previous or concurrent other malignant tumours within 5 years, except cervical
carcinoma in situ, cutaneous squamous cell carcinoma or basal cell carcinoma of the
skin that has been basically controlled;
3. Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable
mental illness or severe intellectual or cognitive dysfunction;
4. Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis,
drug-related pneumonia and severely impaired lung function;
5. Suffering from active autoimmune diseases, history of autoimmune diseases, such as
interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis,
hyperthyroidism; Reduced thyroid function after thyroid hormone replacement therapy
can be included;
6. Have a history of immunodeficiency, including testing positive for HIV, suffering
from other acquired or congenital immunodeficiency diseases, or a history of organ
transplantation and allogeneic bone marrow transplantation;
7. Subjects have cardiovascular clinical symptoms or diseases that cannot be well
controlled, including but not limited to: 1) NYHA class II or above heart failure;
2) Unstable angina; 3) Myocardial infarction within 1 year; 4) Clinically
significant supraventricular or ventricular arrhythmia requiring clinical
intervention;
8. Severe active infection requiring intravenous antibiotic treatment occurs during the
screening period;
9. Those who are allergic to experimental drugs;
10. Patients who cannot comply with the trial protocol or cannot cooperate with
follow-up visits;
11. Those who the researcher believes are not suitable to participate in this trial.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
May 1, 2024
Completion date:
May 1, 2028
Lead sponsor:
Agency:
Harbin Medical University
Agency class:
Other
Source:
Harbin Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06389500
