neuroendocrine neoplasm
Conditions
Interventions
Experimental group:PM8002 + Irinotecan + 5-Fu + Calcium Folinate
Sponsors
PLA General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical studies; Fully understand the study and voluntarily sign the informed consent; Willing to follow and able to complete all test procedures; 2. No gender limit, aged >= 18 years; 3. Ki-67>=55% G3 NET and NEC were confirmed histologically or cytologically by pathological diagnosis in this study; 4. Subjects with neuroendocrine tumors who have previously received first-line chemotherapy with platinum-containing regimen and failed (including progression and intolerance); Subjects receiving neoadjuvant or adjuvant therapy whose disease recurred during treatment or within 6 months after the last treatment were regarded as first-line treatment failure; 5. Measurable lesions that meet the requirements of RECIST1.1 are clearly present; 6. Adequate organ function; 7. Physical status (PS) score of ECOG was 0 ~ 1; 8. Expected survival >= 12 weeks; 9. Subjects should provide formalin-fixed-paraffin-embedded (FFPE) tumor samples during the screening period (up to 24 months) : 10. Fertile female subjects who have had a negative blood pregnancy within 7 days prior to the start of the study and are willing to abstain from sex or use a medically approved highly effective contraceptive method (e.g. iUD, condom) from the time of signing the informed consent to 6 months after the end of the last medication; 11. Male subjects are willing to abstain from sex or use medically approved highly effective contraception for a period of 6 months from the date of signing the informed consent, and do not donate sperm during this period.
Exclusion criteria
Exclusion criteria: 1. History of severe allergic disease, severe allergy to drugs (including unmarketed experimental drugs), or known allergy to any component of the drug in the study; 2. Past receipt of any anti-programmed death Receptor 1 (PD-1) antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, or anti-cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) antibody or any other antibody acting on T-cell costimulation or checkpoint pathways (such as OX40, CD137, etc.); 3. Previous treatment with irinotecan; 4. Past antivascular therapy; 5. UGT1A1 enzyme activity is known to be reduced; 6. Patients with concomitant medication or who have used CYP3A4 strong inducer within 14 days before receiving study drug therapy, or who cannot be suspended from above drugs during the study period; 7. Patients with brain parenchymal metastases or meningeal metastases with clinical symptoms were judged by the researchers to be unsuitable for inclusion; 8. Evidence of significant clotting disorder or other significant bleeding risk: 9. Antitumor therapy for the studied disease was administered within 4 weeks before the study began: 10. Subjects who have previously received antitumor therapy must have all treatment-related toxicity restored to 450 ms for male and > 470 ms for female; (3) The presence of any factors that increase the risk of prolonged QTc or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, or the use of any concomitant drugs known to prolong the QT interval; (4) New York Heart Association cardiac function grade >= II, or left ventricular ejection fraction (LVEF) 38.5°C before the start of the study treatment (according to the investigators, fever due to tumor can be included in the study); 17. Uncontrolled systemic diseases such as hypertension and diabetes existed before the treatment began; 18. Uncontrollable tumor-related pain; 19. There is now a definite case of interstitial lung disease or non-infectious pneumonia; 20.HBsAg positive or HBcAb positive, HBV-DNA >500 IU/mL or higher than the lower limit of detection in the study center (only when the lower limit of detection of HBV-DNA in the study Center is higher than 500 IU/mL); HCV-Ab positive, and HCV-RNA higher than the lower limit of detection center; 21. A history of immunodeficiency, including a positive test for antibodies to human immunodeficiency virus (HIV); 22. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation; 23. A known history of alcohol abuse, psychotropic substance abuse or drug use; 24. Subjects with mental disorders or poor compliance; 25.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate;Incidence and severity of treatment-related adverse events; | — |
Countries
China
Contacts
Public ContactXu Jianming
PLA General Hospital
Outcome results
None listed