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

NCT06389500 | Not Yet Recruiting Phase 2

• 1 other identifier: SHR-1316-HLJ-006
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Biliary Tract Cancer

Keywords

Adebrelimab; Hepatic Arterial Infusion Chemotherapy; Lenvatinib; Potentially Resectable Biliary Tract Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• Surgery conversion rate

  Proportion of patients who can undergo surgical resection among all enrolled patients

  up to 24 months

Secondary Outcomes (6)

• Objective response rate

  up to 24 months

• pathological complete response rate

  up to 24 months

• Major pathological response rate

  up to 24 months

• Recurrence-free survival

  up to 24 months

• Overall survival

  up to 24 months

Study Arms (1)

HAIC+Immune-targeted therapy

EXPERIMENTAL

Hepatic arterial infusion chemotherapy combined with adebrelimab and lenvatinib

Drug: Adebrelimab; Drug: Lenvatinib; Procedure: Hepatic Arterial Infusion Chemotherapy

Interventions

Adebrelimab DRUG

Adebrelimab, IV

Also known as: SHR-1316

HAIC+Immune-targeted therapy

Lenvatinib DRUG

Lenvatinib, PO

Also known as: Lenvatinib Mesilate Capsules

HAIC+Immune-targeted therapy

Hepatic Arterial Infusion Chemotherapy PROCEDURE

GC regimen±5-FU

HAIC+Immune-targeted therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 to 75 years old, male or female;
• Biliary tract malignant tumors confirmed by histology or cytology, with measurable tumor lesions (spiral CT or MR scan ≥10mm, meeting RECIST 1.1 standards);
• Borderline resectable, locally advanced biliary malignant tumors, including gallbladder cancer, intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, and distal cholangiocarcinoma;
• Clinical stage: gallbladder cancer stage: IIIA-IVB; intrahepatic cholangiocarcinoma stage: IIA-IV; hilar cholangiocarcinoma stage: IIIB-IVB; distal cholangiocarcinoma stage: IIIA-IV;
• Expected survival \> 3 months;
• ECOG PS score: 0-1 points;
• Liver function classification is Child-Pugh ≤7;
• Never received prior systemic treatment for biliary tract tumors;
• No peritoneal metastasis or other distant metastasis;
• Normal function of major organs;
• 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;
• Patients voluntarily enrolled in the study by signing an informed consent form.

You may not qualify if:

• Patients diagnosed with periampullary cancer;
• 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;
• Those with uncontrolled, symptomatic brain metastases or a history of uncontrollable mental illness or severe intellectual or cognitive dysfunction;
• Pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia and severely impaired lung function;
• 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;
• 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;
• 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;
• Severe active infection requiring intravenous antibiotic treatment occurs during the screening period;
• Those who are allergic to experimental drugs;
• Patients who cannot comply with the trial protocol or cannot cooperate with follow-up visits;
• Those who the researcher believes are not suitable to participate in this trial.

Sponsors & Collaborators

• Harbin Medical University: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

lenvatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Yubao Zhang, MD

  Harbin Medical University Affiliated Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yubao Zhang, MD

CONTACT

+86 139 3658 8077; zhyb88077@sina.com

Study Design

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

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share