Intrahepatic Cholangiocarcinoma
Conditions
Interventions
Treatment group:Hepatic arterial perfusion + sintilimab + lenvatinib regimen
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent prior to the implementation of any trial-related procedures 2. Male or female>=18 years old, 3 months 6. At least 1 measurable lesion according to RECIST1.1 criteria 7. ECOG PS score of 0-2 8. Child-Pugh Grade A or B 9. Adequate organ function, subjects need to meet the following laboratory indicators: 1) In the absence of granulocyte colony-stimulating factor in the last 14 days, neutrophils absolutely value (ANC)>=1.5x109/L; 2) In the case of no blood transfusion in the past 14 days, platelet >=75×109/L; 3) Hemoglobin >8g/dL without blood transfusion or erythropoietin use in the past 14 days; 4) Total bilirubin =60 ml/min; 7) Good coagulation function, defined as international normalized ratio (INR) or prothrombin time (PT) <=ULN+4 seconds; 8) Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within normal limits. If baseline TSH is outside the normal range, if total T3 (or FT3) and FT4 are normal Subjects in the range may also be enrolled; 9) Cardiac enzyme spectrum within the normal range (if the investigator comprehensively judges that it is not clinically significant, simple laboratory abnormalities are also allowed to be enrolled); 10. For female subjects of childbearing age, a urine or serum pregnancy test with a negative result should be received within 3 days prior to receiving the first dose of study drug (Cycle 1 Day 1). If urine If the pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Females of non-childbearing potential are defined as at least 1 year postmenopausal, or have undergone surgical sterilization or hysterectomy 11. If there is a risk of conception, all subjects, male or female, are required to use contraception with an annual failure rate of less than 1% throughout the treatment period and up to 120 days after the last dose of study drug
Exclusion criteria
Exclusion criteria: 1.Diagnosis of other malignant diseases outside the biliary tract within 5 years prior to the first dose (excluding radically treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or carcinoma in situ treated with curative intent). 2.Currently participating in an interventional clinical study or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose. 3.Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs targeting other stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137). 4.Previous treatment with targeted therapies affecting VEGF and/or VEGFR, RAF, MEK, PDGFR, or FGFR signaling pathways. 5.Prior palliative radiotherapy for biliary tumors, except for postoperative adjuvant radiotherapy. 6.Use of Chinese herbal medicines or immunomodulatory drugs (including thymosin, interferons, interleukins) with antitumor indications within 2 weeks prior to the first dose, excluding localized pleural effusion treatments. 7.Active autoimmune diseases requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapies (e.g., thyroid hormones, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency) are not considered systemic treatments. Patients with a history of primary immunodeficiency or those with positive autoantibodies must be evaluated by the investigator to confirm the presence of autoimmune diseases. 8.Systemic corticosteroid treatment (excluding nasal, inhaled, or other local corticosteroids) or other immunosuppressive therapies within 4 weeks prior to the first dose. Note: Physiological doses of corticosteroids (=10 mg/day prednisone or equivalent) are allowed. 9.Clinically uncontrolled pleural/abdominal effusion (patients without effusion drainage or those with effusion not significantly increasing after stopping drainage for 3 days are eligible). 10.Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation. 11.Known hypersensitivity to the active ingredient or excipients of the study drug (Sintilimab). 12.Failure to fully recover (i.e., = NYHA Grade II. 3)Any arterial thrombosis, embolism, or ischemic events (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months before enrollment. 4)Major surgery (craniotomy, thoracotomy, or laparotomy) within 4 weeks before the first dose, or unhealed wounds, ulcers, or fractures. Biopsy or minor surgeries (e.g., vascular access for IV infusion) within 7 days before the first do
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS);Complete response (CR);Partial response (PR);Stable disease (SD);Progressive disease (PD);Objective response rate (ORR);Disease control rate (DCR); | — |
Countries
China
Contacts
Public ContactZheng Yun
Sun Yat-sen University Cancer Center
Outcome results
None listed