Neuroendocrine tumor
Conditions
Interventions
Experimental group:Camrelizumab 200mg, Q3W
Apatinib mesylate 250mg, qd
Etoposide, D1-3
Cisplatin, D1, Q3W
After 4-6 cycles of treatment, if there is no progress, Camrelizumab (200mg, Q2W) combined with Apatinib treatment will be administered.
Sponsors
Cancer Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. High grade neuroendocrine tumors confirmed by pathology during initial treatment; 2. TNM clinical staging is IIIB-IV stage; 3. Has not received systematic treatment in the past; 4. The ECOG score is 0-1 points; 5. Expected survival time = 3 months; 6. At least one measurable lesion (according to RECIST 1.1 standard, the CT scan length of the tumor lesion is = 10mm, and the CT scan short diameter of the lymph node lesion is = 15mm); 7. Asymptomatic brain metastasis or lesion control after radiotherapy for brain metastasis; 8. There are no significant abnormalities in laboratory routine examinations (blood routine, liver and kidney function, coagulation function, etc.): (1) The blood routine examination standards must comply with (no blood transfusion or blood products within 14 days): ANC = 1.5 × 10^9/L; PLT = 80 × 10^9/L; (2) Biochemical examination must meet the following standards: TBIL45 ml/min (Cockcroft Fault formula); 9. Provide sufficient tissue markers for PD-L1 or TMB testing or blood samples (one week before treatment, immune evaluation every two months) for subsequent analysis; 10. Patients with potential fertility need to use a medically approved contraceptive method (such as an intrauterine device, contraceptive pill, or condom) during the study treatment period and within 1 month after the end of the study treatment period; Within 72 hours before enrollment in the study, serum or urine HCG tests must be negative and must be non lactating; 11.18-80 years old; 12. The subjects voluntarily joined this study and signed an informed consent form, with good compliance and cooperation in follow-up;
Exclusion criteria
Exclusion criteria: 1. Other malignant tumors (patients with repeated cancer) within five years; 2. Previously allergic to any component of the investigational drug: camrelizumab or apatinib; 3. Subjects with intractable pleural or pericardial effusion were poorly controlled; 4. Previously received anti-PD-1 or PD-L1 or CTLA-4 or CAR-T immunotherapy; 5. Have a history of interstitial lung disease (excluding radiation pneumonia not treated with national hormone) and non-infective pneumonia; 6. Subjects have any active autoimmune disease or history of autoimmune disease (For example, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood that has been completely relieved after adulthood can be included; subjects with asthma requiring medical intervention of bronchodilator can not be included); 7. Subjects are using immunosuppressive agents, or systemic or absorbable local hormones to achieve immunosuppressive purposes (dose>10mg/day prednisone or other effective hormones), and continue to use them within 2 weeks before enrollment; 8. Serious infection (CTCAE>Level 2) occurred 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; Baseline chest imaging examination showed active pulmonary inflammation, symptoms and signs of infection within 2 weeks before the first use of the study drug, or the need for oral and intravenous antibiotic treatment, except for prophylactic use of antibiotics; 9. Subjects had acute cardio-cerebrovascular diseases such as acute cerebral infarction, acute coronary syndrome, etc. within one month, and cardiovascular clinical symptoms or diseases were not well controlled; 10. According to NYHA standard, patients with grade III to IV cardiac insufficiency or left ventricular ejection fraction (LVEF)1.5 APTT>1.5 ULN), with bleeding tendency; 13. Wounds or fractures that have not been cured for a long time; Major surgical operation or severe traumatic injury, fracture or ulcer within 4 weeks; 14. Subjects have congenital or acquired immune deficiency (such as HIV infected persons), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value); 15. Persons who have a history of abuse of psychotropic substances and are unable to give up or have mental disorders; 16. According to the judgment of the researcher, there are patients with concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study; 17.The researcher thinks it is not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;Overall survival;Duration of respond;Disease control rate;Quality of life; | — |
Countries
China
Contacts
Public ContactDongyuan zhu
shandong cancer hospital
Outcome results
None listed