Perihilar cholangiocarcinoma
Conditions
Interventions
HAIC Treatment Group:
Prior to HAIC (Hepatic Arterial Infusion Chemotherapy), patients received liver-protective treatments, antiemetics, analgesics, and other symptomatic therapies. For patients with
Sponsors
Beijing Tsinghua Changgung Hosipital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria Patients are eligible to participate in this study only if they meet all the following inclusion criteria and none of the exclusion criteria: Age and Gender: Aged 18-80 years, no restrictions on gender. Diagnosis: Diagnosed with unresectable or regionally recurrent perihilar cholangiocarcinoma through pathological histology/cytology or with typical imaging features and elevated tumor markers after puncture decompression. Unresectable/Regionally Recurrent Disease: Definition of Unresectable Disease: Anatomical factors: (a) Atrophy of one liver lobe with extensive involvement of the contralateral bile duct, hepatic artery, or portal vein. (b) Simultaneous involvement of both bile ducts, making curative resection infeasible (tumor involves both U and P points). (c) Main portal vein involvement >3 cm, rendering reconstruction impossible. (d) Both hepatic arteries and portal veins involved, without possibility of reconstruction. (e) Extensive involvement of extrahepatic nerves, proper hepatic artery, or common hepatic artery, with tumor invasion of hepatic and inferior vena cava veins. (f) Patients with decompensated liver cirrhosis or severe portal hypertension, with an insufficient future liver remnant (FLR) for safe resection. Biological factors: Regional lymph nodes include nodes within the hepatoduodenal ligament (No.12h, No.12a, No.12b, No.12p, No.12c), around the common hepatic artery (No.8a, No.8p), and posterior superior pancreaticoduodenal nodes (No.13a). Distant metastasis is defined as involvement of nodes outside these regions or metastases to the liver, lungs, or peritoneum as confirmed by PET-CT or biopsy. Conditional factors: Inability to tolerate surgery with ECOG performance status =2. Definition of Regional Recurrence: Recurrence after surgery involving the hepatic hilum, hepaticojejunal anastomosis, liver resection margins, distal bile duct, retroperitoneal lymph nodes, or intrahepatic recurrence distant from resection margins. Bilirubin Levels: Serum total bilirubin =100 µmol/L after puncture decompression. Performance Status: ECOG score of 0-1. Liver Function: Child-Pugh classification of A or B (=7 points). Measurable Lesion: At least one measurable lesion per RECIST v1.1 criteria. Treatment History: No prior systemic therapy or local anti-tumor treatments except surgery (biliary drainage is allowed). Adjuvant therapy completed at least 6 months prior is acceptable. Chemotherapy Tolerance: Patients who refuse or are intolerant to systemic chemotherapy. Organ Function: Bone marrow: Absolute neutrophil count (ANC) =1.5 × 10?/L. Hemoglobin (Hb) =8.5 g/dL. Platelet count =75 × 10?/L. Liver: Albumin =2.8 g/dL. AST, ALP, and ALT =5 × ULN. Coagulation: INR =2.3. Kidneys: Creatinine clearance =40 mL/min (calculated by Cockcroft-Gault formula). Pancreas: Amylase and lipase =1.5 × ULN. Blood Pressure: Controlled with up to 3 antihypertensive medications, defined as BP =150/90 mmHg during screening and stable within one week before Cycle 1/Day 1. Life Expectancy: Estimated survival of more than 3 months. Pregnancy: No pregnancy or plans for pregnancy. Voluntary Participation: Patients must voluntarily consent to participate in the study, sign the informed consent form, and demonstrate good compliance for follow-up.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Patients with any of the following conditions are not eligible for inclusion: History of Other Malignancies: Diagnosis of a malignancy other than biliary tract cancer within 5 years prior to the first dose of the study treatment (excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ). Non-Cholangiocarcinoma Components: Diagnosis of malignancies such as hepatocellular carcinoma, mixed-type carcinoma, or fibrolamellar carcinoma. Antitumor or Immunomodulatory Treatments: Systemic administration of traditional Chinese medicine or immunomodulatory drugs (e.g., thymosin, interferon, interleukin, excluding local pleural effusion control) for antitumor indications within 2 weeks before the first dose. Autoimmune Diseases: Active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroids for adrenal or pituitary insufficiency) is allowed. Patients with a history of primary immunodeficiency or positive autoimmune antibodies without diagnosed autoimmune disease must be assessed for eligibility by the investigator. Corticosteroid Use: Use of systemic corticosteroids or other immunosuppressive therapies within 4 weeks prior to the first dose, except for local corticosteroid applications (nasal, inhaled, etc.) or physiologic doses (=10 mg/day of prednisone or equivalent). Prior Treatment: Previous chemotherapy, immune checkpoint inhibitors, or other treatments affecting the study drugs. Drug Allergy: Known allergy to hepatic arterial infusion chemotherapy agents or durvalumab components. Transplant History: History of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. Vaccination: Receipt of a live attenuated vaccine within 4 weeks prior to the first dose. HCV Infection: Active HCV infection (positive HCV antibodies and HCV-RNA levels above detection limits). Cardiac Conditions: Grade II or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval =470 ms), heart failure (NYHA class III–IV), or LVEF <50% on echocardiography. Pregnancy and Breastfeeding: Pregnant or breastfeeding women, or patients of childbearing potential unwilling or unable to use effective contraception. Mental Health and Substance Abuse: History of psychiatric disorders or substance abuse. HIV Infection: Known HIV infection. Active Infections: Presence of active infections. Poor Compliance: Patients with poor compliance, such as transient populations. Other Clinical Trials: Participation in another investigational drug or device study within 4 weeks prior to the first dose. Metastasis: Only patients with unresectable perihilar cholangiocarcinoma confirmed by preoperative PET-CT or histologic biopsy with regional lymph node or liver metastasis are eligible. Patients with distant metastases (e.g., lung, bone, or peritoneum) will be excluded. Investigator's Judgment: Any condition that, in the investigator's opinion, makes the patient unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease Control Rate (DCR);Overall Survival (OS);Time to Response (TTR);Duration of Response (DoR);Progression-Free Survival (PFS); | — |
Countries
China
Contacts
Public ContactCanhong Xiang
Beijing Tsinghua Changgung Hosipital
Outcome results
None listed