Advanced extrapulmonary neuroendocrine carcinoma
Conditions
Interventions
Trial group:Intravenous infusion of 5mg/kg of apalolithovolrelimab every three weeks
Combined with albumin-paclitaxel at a dose of 100mg/m2 by intravenous infusion (on days 1 and 8), bevacizumab at a dose of 7.5mg/m2 by intravenous infusion (on day 1), and radiotherapy selected based
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender not limited; 2. Patients with advanced extrapulmonary neuroendocrine carcinoma that cannot be surgically resected or has metastasized, as confirmed by histology or cytology; 3. ECOG PS score 0-1; 4. Expected survival period >=3 months; 5. It is clear that there are measurable lesions that meet the requirements of the Solid Tumor Efficacy Evaluation Criteria (RECIST 1.1); If the lesion that has received local treatment (radiotherapy, ablation, vascular intervention, etc.) in the past is the only lesion, then this lesion must exist. 6. Failure of standard treatment (disease progression after treatment or intolerable toxic and side effects of treatment); 7. Adequate organ and bone marrow function (1) Blood routine test (no blood transfusion, no blood products, no use of granulocyte colony-stimulating factor or other hematopoietic stimulating factor correction within 7 days before laboratory test) 1) Hemoglobin (HGB) >=90g/L; 2) The absolute value of neutrophil count (ANC) is >=1.5×10^9/L; 3) Platelet count (PLT) >=100×10^9/L; (2) Biochemical tests: 1) Aspartate transferase (AST) and alanine aminotransferase (ALT) =30g/L; 4) Serum creatinine (Cr) =60mL/min (Cockcroft-Gault formula); 5) The activated partial thromboplastin time (APTT) is less than or equal to 1.5×ULN, and the international normalized ratio (INR) or prothrombin time (PT) is less than or equal to 1.5×ULN (without anticoagulation therapy); 8. The pregnancy test of women of childbearing age is negative; Fertile men and women of childbearing age must agree to take contraceptive measures throughout the study period. 9. Willing and able to accept follow-up until death or the end of the study or the termination of the study; 10. Patients who are determined by researchers to be suitable for radiotherapy; 11. Voluntarily join this study and be able to understand and voluntarily sign the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. The toxicity related to previous anti-tumor treatments did not recover to 30 mL within 2 months, with hematemesis, melena, or hematochezia), or hemoptysis (fresh blood >5 mL within 4 weeks); 12. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe/unstable angina pectoris or coronary artery bypass grafting within 6 months before the first administration; Congestive heart failure is classified as grade 2 or above by the New York Heart Association (NYHA). Left ventricular ejection fraction (LVEF) <50%; 13. Women who are pregnant (with a positive pregnancy test before medication) or are breastfeeding; 14. Positive for HBsAg and the level of hepatitis B virus DNA in peripheral blood exceeds 1×10^3 copies /L; 15. Positive for anti-human immunodeficiency virus antibody; 16. Suffering from any serious or unstable illness or mental disorder; 17. Suffering from serious concomitant diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances where the researcher deems the patient unsuitable to participate in this study; 18. Curre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival evaluated by researchers based on RECIST1.1; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate, duration of response, disease control rate, and overall survival evaluated by researchers based on RECIST1.1;Safety indicators (including: incidence and severity of adverse events (AE), and outliers of laboratory indicators); | — |
Countries
China
Contacts
Public ContactFeng Tingting
Zhejiang Cancer Hospital
Outcome results
None listed