Upper gastrointestinal neuroendocrine carcinoma
Conditions
Interventions
Xindilimab+Bevacizumab+Albumin Paclitaxel:Xindilimab,Bevacizumab,Albumin Paclitaxel
Sponsors
The First Affiliated Hospital of Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Qualified participants for this study must meet all of the following criteria: Sign written informed consent before implementing any experimental procedures; 2.Age >= 18 years old, 3 months; 8.Adequate organ function, subjects must meet the following laboratory indicators: In the past 14 days without using granulocyte colony-stimulating factor, the absolute neutrophil count (ANC) was >= 1.5x109/L. Platelets >= 100 × 109/L without blood transfusion in the past 14 days. Hemoglobin>9g/dL in the past 14 days without blood transfusion or use of erythropoietin Total bilirubin = 60 ml/min Good coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) <= 1.5 times ULN Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included) (Optional); 9.For female participants of childbearing age, a urine or serum pregnancy test should be conducted within 3 days prior to the first administration of the study drug (Day 1 of the first cycle) and the result should be negative. If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Non childbearing women are defined as those who have been postmenopausal for at least one year or have undergone surgical sterilization or hysterectomy; 10.If there is a risk of conception, all subjects (male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the entire treatment period until 120 days after the last administration of the study drug (or 180 days after the last administration of chemotherapy drug).
Exclusion criteria
Exclusion criteria: 1.Diagnosed with malignant diseases other than NEC within 5 years prior to the first administration (excluding curative basal cell carcinoma, squamous cell carcinoma, and/or excised carcinoma in situ); 2.Currently participating in interventional clinical research treatment, or participating in other clinical studies within 3 months of the first administration; 3.Previously received the following therapies: anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs, or drugs that stimulate or synergistically inhibit T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.); 4.Within 2 weeks before the first administration, he has received systematic systemic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or drugs with immunomodulatory effects (including thymosin, interferon, interleukin, except for local use to control pleural effusion); 5.An active autoimmune disease requiring systemic treatment (such as the use of disease relieving drugs, corticosteroids, or immunosuppressants) has occurred within 2 years prior to the first administration. Alternative therapies (such as thyroid hormone, insulin, or physiological glucocorticoids used for adrenal or pituitary insufficiency) are not considered systemic treatments; 6.Within 7 days prior to the first administration of the study, the individual was receiving systemic corticosteroid therapy (excluding topical corticosteroids via nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy Note: Physiological doses of glucocorticoids (30 mL within 2 months, vomiting blood, black stool, and rectal bleeding), hemoptysis (fresh blood>5 mL within 4 weeks); 12.Has experienced arterial or deep vein thrombosis within 6 months prior to the first use of medication; Or have experienced a stroke and/or transient ischemic attack within the past 12 months; Previously received any paclitaxel drugs, including docetaxel, liposomal paclitaxel, paclitaxel, and bevacizumab treatment; 13.Prior to commencing treatment, the individual has not fully recovered from any toxicity and/or complications caused by any intervention measures (i.e., <= grade 1 or baseline, excluding fatigue or hair loss); 14.Known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1/2 antibody positive); 15.Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center); Note: hepatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;DCR;DOR;OS;AE; | — |
Countries
China
Contacts
Public Contactjinyin
The First Affiliated Hospital of Wenzhou Medical University
Outcome results
None listed