biliary tract cancer
Conditions
Interventions
Intervention group:Lukang saltuzumab, dosage: 5mg/kg, intravenous infusion, administered once every 2 weeks, on the first day of each cycle.
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. At the time of signing the informed consent, age >=18 years and both genders. 2. Histologically or cytologically confirmed unresectable locally advanced or metastatic stage IV (AJCC 8th edition TNM staging: T any N any M1) biliary tract malignancy (cholangiocarcinoma/gallbladder cancer/ampullary carcinoma) according to the WHO Classification of Digestive System Tumors, 5th edition. 3. At least one measurable target lesion per RECIST v1.1 as assessed by the investigator. 4. Have received first-line standard chemotherapy containing gemcitabine plus platinum (cisplatin or oxaliplatin). 5. Progressed during or within 6 months after the treatment. 6. At least 4 weeks since the last chemotherapy. 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2. 8. Expected survival >=12 weeks. 9. Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor within 2 weeks before the first dose), defined as follows: (1) Complete blood count: absolute neutrophil count (NEUT#) >=1.5×10^9/L; platelet count (PLT) >=100×10^9/L; hemoglobin >=90 g/L. (2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =30 g/L; total bilirubin (TBIL) =50 mL/min (calculated using the standard Cockcroft-Gault formula). (4) Coagulation function: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <=1.5×ULN. 10. For female subjects of childbearing potential and male subjects with partners of childbearing potential, they must agree to use effective medical contraception from the signing of the informed consent until 6 months after the last dose. 11. Subjects voluntarily participate in this study, sign the informed consent form, and are able to comply with the scheduled visits and related procedures as required by the protocol.
Exclusion criteria
Exclusion criteria: 1. Participated in other drug clinical trials within 4 weeks before enrollment. 2. Previously received TROP2-targeted therapy and/or topoisomerase I inhibitor therapy. 3. Have had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin. 4. Known hypersensitivity to the study drug sacituzumab tirumotecan or any of its components. 5. Biliary obstruction not resolved. 6. Baseline QTc interval >480 ms. 7. Requiring abdominal paracentesis for ascites at a frequency of >=1 time per week. 8. Positive human immunodeficiency virus (HIV) test or known history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection. 9. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 10. Received live vaccine within 30 days before the first study drug administration. 11. History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonitis requiring steroid treatment, currently has ILD or non-infectious pneumonitis, or has suspected ILD or non-infectious pneumonitis that cannot be ruled out by imaging at screening; clinically severe pulmonary impairment due to concurrent pulmonary diseases, including but not limited to any underlying pulmonary condition (e.g., pulmonary embolism within 3 months before dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or previous pneumonectomy. 12. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., type I diabetes mellitus, hypothyroidism requiring only thyroid hormone replacement, and adrenal or pituitary insufficiency requiring only physiological glucocorticoid replacement therapy). 13. Active infection requiring systemic treatment within 2 weeks before the first dose. 14. According to the investigator's judgment, concurrent diseases that seriously endanger patient safety or affect the patient's ability to complete the study, including but not limited to uncontrolled hypertension, severe diabetes, active infection, etc. 15. Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal diseases that prevent delayed corneal healing. 16. Known leptomeningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, or active central nervous system (CNS) metastases. For subjects with brain metastases who have received prior local treatment, they may participate if they are clinically stable for at least 4 weeks before drug administration and do not require glucocorticoids or anticonvulsants for at least 14 days; for subjects with untreated asymptomatic brain metastases, enrollment may be allowed after evaluation by the investigator. 17. Requiring use of strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose and during the study period (use of strong CYP3A4 inhibitors or inducers is not permitted in this study); all subjects must avoid concomitant use of any drugs, herbal supplements, and/or intake of foods known to induce CYP3A4. 18. Pregnant or breastfeeding female patients; fe
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate(ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival(OS);Progression-Free Survival(PFS);Disease control rate(DCR);Duration of remission (DOR);Adverse Events (AE); | — |
Countries
China
Contacts
Public ContactHan Zhengxiang
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed