Clinical trial NCT06389500: HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer
Official title: Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab and Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer: a Single-arm, Exploratory Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Biliary Tract Cancer
Keywords: Adebrelimab
Hepatic Arterial Infusion Chemotherapy
Lenvatinib
Potentially Resectable Biliary Tract Cancer
Lead sponsor: Harbin Medical University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: R0 resection rate
timeFrame: up to 24 months
measure: Surgery conversion rate
timeFrame: up to 24 months
Secondary outcomes:
measure: Objective response rate
timeFrame: up to 24 months
measure: pathological complete response rate
timeFrame: up to 24 months
measure: Major pathological response rate
timeFrame: up to 24 months
measure: Recurrence-free survival
timeFrame: up to 24 months
measure: Overall survival
timeFrame: up to 24 months
measure: AEs
timeFrame: up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Harbin Medical University Affiliated Cancer Hospital
name: Yubao Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: