Locally advanced or metastatic malignant biliary tract tumors
Conditions
Interventions
Trial Group:Bemotuzumab vedotin 1200mg (Day 1, IV) + Gemcitabine 1000mg/m^2 (Day 1, Day 8, IV) + Cisplatin 25mg/m^2 (Day 1, Day 8, IV) + Ruxolitinib 10mg (Day 1-21, oral), every 21 days for 6 cycles
Sponsors
Wuxi people’s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age: 18 to 75 years; both males and females are eligible. 2. Pathologically confirmed locally advanced or metastatic gallbladder cancer or intrahepatic/extrahepatic cholangiocarcinoma that is unresectable and untreated, with at least one measurable lesion according to RECIST version 1.1. Tissue samples must be provided for biomarker analysis; recently obtained tissue is preferred. If recent tissue is unavailable, archived formalin-fixed paraffin-embedded (FFPE) sections (5 um thick), 5–8 slides, may be submitted. 3. ECOG performance status: 0–1. 4. Expected survival duration >=12 weeks. 5. Normal function of major organ systems, meeting the following criteria: (1) Complete blood count: 1) Hemoglobin (Hb) >=90 g/L (no blood transfusion within the preceding 14 days); 2) Absolute neutrophil count (ANC) >=1.5^x10^9/L; 3) Platelet count (PLT) >=80^x10^9/L. (2) Biochemical parameters: 1) Albumin (ALB) >=30 g/L (no albumin infusion within the preceding 14 days); 2) ALT and AST =60 mL/min. 6. Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >=the lower limit of normal (>=50%). 7. The subject voluntarily consents to participate in this study, provides signed informed consent, and agrees to comply with all scheduled visits and procedures outlined in the protocol. 8. Female subjects of childbearing potential, or male subjects whose partners are of childbearing potential, must use effective contraception throughout the treatment period and for 6 months after the last dose of study therapy.
Exclusion criteria
Exclusion criteria: 1. It has been confirmed that there is an allergy to the component of bemosubemab; 2. Suffering from Grade I or above coronary heart disease, Grade I arrhythmia (including QTc interval prolongation>450 ms in males and>470 ms in females), and Grade I cardiac dysfunction; 3. Patients with central nervous system metastases; 4. Pregnant or lactating women; 5. Patients with other malignant tumors within 5 years (excluding cured skin basal cell carcinoma and cervical carcinoma in situ); 6. Patients with a history of abuse of psychotropic drugs who are unable to quit or those with mental disorders; 7. Patients who have participated in clinical trials of other drugs within 4 weeks; 8. Patients with thyroid dysfunction; 9. Urine protein >=++ or 24-hour urine protein quantification greater than 1.0g; 10. Received target lesion radiotherapy within 4 weeks prior to the first dose of study treatment; 11. Have used immunosuppressive drugs within 4 weeks prior to the first dose of study treatment, excluding topical corticosteroids via nasal spray, inhalation, or other routes, or systemic corticosteroids at physiological doses (i.e. not exceeding 10 mg/day of prednisone or equivalent doses of other corticosteroids); 12. Within 4 weeks prior to the first dose of study treatment or planned to receive attenuated live vaccine during the study period; 13. Prior to the first dose of study treatment, there was toxicity (excluding hair loss, non clinically significant, and asymptomatic laboratory abnormalities) caused by previous anti-tumor therapy that did not recover to grade 0 or 1 of the National Cancer Institute Common Adverse Event Terminology 4.03 (NCI CTCAE 4.03); 14. It is known that there are symptomatic central nervous system metastases and/or cancerous meningitis. Subjects who have received previous treatment for brain metastases can participate in the study, provided that the brain metastases have remained stable for at least 4 weeks prior to the first dose of study treatment; And the neurological symptoms must have already recovered to NCI CTCAE 4.03 level 0 or 1; 15. Active, known or suspected autoimmune disease or medical history of the disease in the past 2 years (vitiligo, psoriasis, alopecia or Grave's disease that do not need systematic treatment in the past 2 years, hypothyroidism that only needs thyroid hormone replacement treatment, and type I diabetes patients that only need insulin replacement treatment can be included in the group); 16. Uncontrolled concurrent diseases include but are not limited to: HIV infected individuals (HIV antibody positive). Severe infections that are in the active phase or poorly controlled clinically; 17. Symptomatic congestive heart failure (New York Heart Association classification II-IV) or symptomatic or poorly controlled arrhythmias. 18. Any arterial thromboembolic events, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, occurred within the 6 months prior to being selected for treatment; 19. Significant malnutrition, such as the need for intravenous nutrient supplementation; Excluding malnutrition correction for more than 4 weeks before the first dose of study treatment; 20. A history of deep vein thrombosis, pulmonary embolism, or any other severe thromboembolism within the first 3 months of enrollment (implantable venous infusion port or catheter-related thrombosis, or superficial venous thrombosis is not considered a "severe" thromboembolism);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-Free Survival (PFS);Duration of Response (DoR);Disease Control Rate (DCR);Hamilton Anxiety and Depression Scale Scores;Quality of Life Score (EORTC QLQ-C30);Intestinal Microbiota Abundance;Tumor Immune Microenvironment Biomarkers;Peripheral Blood Immunological Predictive Biomarkers; | — |
Countries
China
Contacts
Public ContactDing Junli
Wuxi people’s Hospital
Outcome results
None listed