Extrapulmanary neuroendocrine carcinoma
Conditions
Interventions
experimental group:Camrelizumab plus EP/EC (Etoposide + Cisplatin/Carboplatin)
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The full inclusion criteria were as follows: 1. Histologically and/or cytologically confirmed, unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (EP-NEC), with primary sites located in non-pulmonary organs such as the gastrointestinal tract, pancreas, or biliary tract;The pathological diagnosis of gastrointestinal neuroendocrine carcinoma will be established according to the 2019 WHO Classification of Tumours of the Digestive System; 2. Aged >= 18 years, male or female; 3. Estimated life expectancy >= 12 weeks; 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; 5. No prior first-line palliative systemic antitumor therapy for advanced or metastatic disease; 6. At least one measurable lesion according to RECIST version 1.1, documented by imaging within 28 days prior to enrollment. For helical CT, the longest diameter of the target lesion must be >= 1 cm; for conventional CT or MRI, the longest diameter must be >= 2 cm; 7. Patients must have adequate organ function based on laboratory tests performed within 7 days prior to enrollment, without having received blood transfusion, granulocyte colony-stimulating factor (G-CSF), or other medical support within 14 days prior to the first dose of study drug. The laboratory criteria are as follows: Hemoglobin = 90 g/L; Platelets (PLT) >= 75 × 10^9/L; White blood cells (WBC) >= 3.0 × 10^9/L; Absolute neutrophil count (ANC) >= 1.5 × 10^9/L; Total bilirubin (TBI) <= 1.5 × upper limit of normal (ULN); Serum creatinine (Cr) <= 1.5 × ULN; Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5 × ULN (= 5 × ULN in the presence of liver metastases); 8. Patients with active hepatitis B or hepatitis C infection may be enrolled if they have received effective antiviral therapy for at least 14 days prior to the first dose of study treatment and meet all of the following conditions: Hepatitis B virus (HBV) DNA <= 500 IU/mL or <= 2500 copies/mL; Hepatitis C virus (HCV) RNA below the lower limit of detection of the assay; Willing to continue effective antiviral therapy throughout the study period. 9. Patients are willing to participate in the study and have signed a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Histologically confirmed diagnosis of Neuroendocrine Tumor (NET) or Mixed Neuroendocrine-Non-Neuroendocrine Neoplasm; 2. Severe hepatic or renal insufficiency, or a history of myocardial infarction within 3 months prior to enrollment; 3. History of another malignancy with a disease-free interval of 38°C attributable to infection; 8. Presence of serious internal or surgical diseases that significantly impair organ function and, in the opinion of the investigator, render the patient unsuitable for this clinical trial; 9. Pregnant or breastfeeding women, or men and women of childbearing potential (including women who are less than 1 year post-menopause) who are unwilling to use effective contraception; 10. History of long-standing chronic diarrhea, or the presence of complete bowel obstruction; 11. Requirement for systemic corticosteroids at a dose > 10 mg/day of prednisone or equivalent, or other systemic immunosuppressive therapy, within 14 days prior to the first dose of study treatment. Note: In the absence of active autoimmune disease, the following are allowed: inhaled or topical corticosteroids, physiologic replacement doses of corticosteroids (<= 10 mg/day prednisone or equivalent), and short-term (<= 7 days) systemic corticosteroids for prophylaxis (e.g., contrast allergy) or treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reactions to contact allergens); 12. Prior treatment with any antibody or drug targeting T-cell co-regulatory (immune checkpoint) proteins, including but not limited to anti–PD-1, anti–PD-L1, anti–CTLA-4, anti–OX40, anti–CD137, anti–TIM-3, or anti–LAG-3 antibodies; 13. History of severe hypersensitivity reactions to any component of the study drug formulation; 14. Known immunodeficiency disorders or known human immunodeficiency virus (HIV) infection; 15. Any patient considered unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival at 6 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Adverse effects rate;Progression free survival; | — |
Countries
China
Contacts
Public ContactCao Dan, Li Xiaofen
West China Hospital of Sichuan University
Outcome results
None listed