HAIC+Adebrelimab+Lenvatinib for Conversion Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

Biliary Tract Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389500
• Other study ID #: SHR-1316-HLJ-006
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: April 2024
• Source: Harbin Medical University
• Contact: Yubao Zhang, MD
• Phone: +86 139 3658 8077
• Email: zhyb88077[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 (ßHCG) 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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms

Intervention

Drug:
• Adebrelimab
Adebrelimab, IV
• Lenvatinib
Lenvatinib, PO

Procedure:
• Hepatic Arterial Infusion Chemotherapy
GC regimen±5-FU

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Harbin Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R0 resection rate	Postoperative staining results showed that the lesion was completely resected, and pathological biopsy of the transverse and longitudinal margins were negative.	up to 24 months
Primary	Surgery conversion rate	Proportion of patients who can undergo surgical resection among all enrolled patients	up to 24 months
Secondary	Objective response rate	The proportion of patients whose tumor volume shrinks to a predetermined value and can maintain the minimum time limit, which is the sum of the proportions of complete remission and partial remission.	up to 24 months
Secondary	pathological complete response rate	After preoperative treatment and surgery, there are no residual viable tumor cells in the tumor bed in the postoperative specimen (%RVT=0)	up to 24 months
Secondary	Major pathological response rate	After preoperative treatment and surgery, the proportion of residual viable tumor cells in the tumor bed in the postoperative specimen is less than or equal to 10% (%RVT=10)*	up to 24 months
Secondary	Recurrence-free survival	Duration from surgical resection to first recurrence or death from any cause	up to 24 months
Secondary	Overall survival	Overall survival is measured from the first dose of study drug until death from any cause.	up to 24 months
Secondary	AEs	Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.	up to 24 months