Unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma
Conditions
Interventions
Treatment group:Immunotherapy ( Iparomlimab and Tuvonralimab) + Targeted Therapy (Lenvatinib) + Hepatic Arterial Infusion Chemotherapy
Sponsors
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically or cytologically confirmed unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma; 2. Aged 18 years or older, male or female; 3. No prior systemic treatment for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma; those who have received one adjuvant or neoadjuvant chemotherapy regimen and relapsed more than 6 months after the end of chemotherapy are eligible for enrollment; 4. Expected survival time > 3 months; 5. ECOG PS score of 0 or 1; 6. Liver function of Child-Pugh Class A (5-6 points) or good Class B (= 10 mm on spiral CT scan or enlarged lymph nodes with a short diameter of >= 15 mm); 8. The patient's organ and hematological functions meet the following requirements: a) Routine blood test: White blood cell count >= 4.0×10?/L, neutrophil count >= 1.5×10?/L, platelet count >= 100×10?/L, hemoglobin >= 90g/L; b) International normalized ratio (INR) 60mL/min; e) Cardiac function: Left ventricular ejection fraction (LVEF) detected by two-dimensional echocardiography >= 50%. 9. Patients with potential fertility need to use a medically approved contraceptive method (such as intrauterine device, contraceptives or condoms) during the study treatment and within 1 month after the end of the study treatment; and the serum or urine HCG test must be negative within 72 hours before enrollment in the study, and they must be non-lactating; 10. Patients can understand and sign the informed consent form to participate in the trial study; with good compliance.
Exclusion criteria
Exclusion criteria: 1. Having received approved or investigational local or systemic anti-tumor therapy within 4 weeks prior to enrollment, including interventional therapy, chemotherapy, biological immunotherapy, targeted therapy, etc.; 2. Clinically intervened biliary obstruction that, as judged by the investigator, has not been relieved or requires anti-infective treatment within 14 days before the first administration of the study drug; 3. A history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 4. Symptomatic or previous central nervous system metastasis: Those who have received systemic or radical treatment (radiotherapy or surgery) for brain or meningeal metastasis, with imaging confirming stability for at least 1 month, having stopped systemic hormone therapy (dose > 10mg/day prednisone or other hormones with equivalent efficacy) for more than 2 weeks, and being asymptomatic can be included; 5. Having participated in other clinical trials of domestically unapproved or unmarketed drugs and received corresponding trial drug treatment within 4 weeks prior to enrollment; 6. Previous use of anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-lymphocyte antigen 4 (CTLA-4) antibody therapy; 7. Having used immunosuppressive drugs within 14 days before medication, excluding nasal spray and inhaled corticosteroids or systemic corticosteroids at physiological doses (i.e., not exceeding 10mg/day prednisone or other corticosteroids at equivalent physiological doses); 8. A history of autoimmune diseases, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, a history of interstitial lung disease with active pneumonia detected by chest CT scan, active tuberculosis, etc.; 9. Those who have received live vaccine inoculation within 4 weeks before the start of treatment; 10. Those who have received anti-tumor vaccines or anti-tumor therapies with systemic immune-stimulating effects; 11. Having undergone any major surgical operation or invasive treatment or procedure (except for venous catheterization, puncture drainage, puncture biopsy, etc.) within 4 weeks before the start of enrollment; 12. Patients with poorly controlled hypertension by medication, defined as: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg; 13. Patients with any disease or condition that affects drug absorption, or patients who are unable to take lenvatinib orally; 14. Patients with active peptic ulcers in the stomach and duodenum, ulcerative colitis, or other gastrointestinal diseases, or active bleeding from unresected tumors, or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation; 15. Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding > 30 mL within 3 months, with hematemesis, melena, hematochezia), hemoptysis (> 5mL of fresh blood within 4 weeks), or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months; 16. Having significant clinically meaningful cardiovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; congestive heart failure with New York Heart Association (NYHA) classification > grade 2; ventricular arrhythmias requiring drug treatment; electrocardiogram (ECG) showing QTc
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival;Overall Survival;Disease Control Rate;Safety; | — |
Countries
China
Contacts
Public ContactJingtao Zhong
Shandong First Medical University and Shandong Academy of Medical Sciences (Shandong Cancer Hospital &Institute)
Outcome results
None listed