Advanced biliary tract cancer
Conditions
Interventions
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75, regardless of gender; 2. Histologically or pathologically confirmed unresectable advanced, recurrent, or metastatic BTCs, including intrahepatic cholangiocarcinoma (IHCC), extrahepatic cholangiocarcinoma (EHCC), and gallbladder cancer (GBC); 3. Patients with distant metastasis or locally advanced disease who are ineligible for surgery or radiotherapy and demonstrate radiological (e.g., CT scans) or clinical evidence (e.g., cytology reports of new ascites or pleural effusion) of disease progression during or after first-line chemotherapy are eligible for the study. Participants must have received at least one dose of first-line treatment, with adjustments such as dose reduction, discontinuation of a single agent, or substitution of fluoropyrimidine drugs permitted within this regimen due to intolerance. Patients whose first-line treatment was discontinued due to toxicity-related intolerance are also eligible. Additionally, neoadjuvant or adjuvant therapy (chemotherapy or chemoradiotherapy) will be considered as first-line treatment if disease progression occurs during treatment or within 6 months post-treatment cessation. 4. ECOG PS 0 or 1; 5. The survival period is expected to be at least 3 months; 6. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1); 7. With adequate organ and bone marrow function (not having received blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor treatment within 2 weeks prior to the first dose), as defined below: a) Hematological assessment: neutrophil count (NEUT#) >= 1.5×10^9/L; platelet count (PLT) >= 100×10^9/L; hemoglobin level >= 9 g/dL; b) Hepatic function: aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) = 60 ml/min, calculated using the Cockcroft-Gault formula; d) Coagulation profile: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5 times ULN; 8. Female patients with a negative serum pregnancy test and reproductive potential are required to consent to the use of an effective non-hormonal contraceptive method throughout the treatment period and for at least 3 months following the last administration of the investigational drug; 9. The subjects voluntarily join this study, sign the informed consent documents, demonstrate good compliance, and cooperate in the follow-up.
Exclusion criteria
Exclusion criteria: 1. Ampullary carcinoma; 2. Prior treatment involving TROP2-targeted therapies and/or topoisomerase I inhibitors; 3. History of allergy to any component of the investigational drug (Sacituzumab Tirumotecan); 4. Within the past 5 years, patients with a history of other malignant tumors are noted, excluding those with cured cervical in situ carcinoma, basal cell carcinoma, or squamous cell carcinoma of the skin; 5. Patients who had a history of allergies to the proposed drug and its components, immune deficiency, or organ transplantation; 6. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA > 1000 copies/mL [200 IU/mL] or above the lower limit of detection, whichever is higher) are excluded unless they receive anti-hepatitis B virus treatment throughout the study period. Subjects with active hepatitis C (HCV antibody positive and detectable HCV-RNA) are also excluded. 7. Known active pulmonary tuberculosis (TB): Subjects suspected of having active TB must undergo appropriate clinical evaluations, including diagnostic testing, to exclude active TB prior to enrollment. 8. Documented active syphilis infection; 9. A history of interstitial lung disease (ILD) or non-infectious pneumonitis necessitating steroid treatment is present, or the patient currently has ILD or non-infectious pneumonitis, or there exists suspicious ILD or non-infectious pneumonitis that cannot be excluded by imaging during screening; clinically significant pulmonary damage resulting from complications, including but not limited to any underlying lung conditions (such as pulmonary embolism within 3 months prior to administration, severe asthma, advanced chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases potentially affecting the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis), as well as a history of total lung resection; 10. Patients with an active autoimmune disease requiring systemic treatment within the past 2 years (note that hormone replacement therapy is not classified as systemic treatment, including conditions such as type 1 diabetes, which necessitates only insulin replacement; hypothyroidism requiring solely thyroid hormone replacement; and adrenal or pituitary insufficiency managed exclusively with physiological glucocorticoid replacement); 11. Active infections necessitating systemic treatment must be present within two weeks prior to the administration of the first dose; 12. Based on the investigators' assessment, serious comorbidities that threaten patient safety or prevent study completion exist, including but not limited to uncontrolled hypertension despite treatment, severe diabetes, and active infections; 13. A documented history of mental illness, drug abuse, alcoholism, or substance dependence; 14. Participants who are pregnant, lactating, or planning to breastfeed during the study period; 15. The researchers consider any other circumstances making the patient unfit for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR);Safety;Overall survival (OS);Duration of response (DOR);Objective Response Rate (ORR); | — |
Countries
China
Contacts
Public ContactZong Hong
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed