Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm

• Status: Not yet recruiting
• Trial end date: 2024-11-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to explore the efficacy and safety of chidamide combined with sintilimab in chemotherapy-refractory advanced high-grade neuroendocrine neoplasm.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Harbin Medical University; The First Affiliated Hospital of Xiamen University

Criteria

Inclusion Criteria:

1. Age ≥ 18 years;

2. Histologically confirmed advanced and metastatic high-grade neuroendocrine neoplasm;

3. Receive ≤ 2 types of chemotherapy for high-grade neuroendocrine tumors and had tumor progression;

4. ECOG ≤ 2;

5. Have at least one measurable lesion according to RECIST version 1.1;

6. Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;

7. Provide tumor samples for pathological diagnosis and PD-L1 biomarker detection;

8. Have ability to sign a written informed consent.

Exclusion Criteria:

1. Small cell lung cancer;

2. Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;

3. Previous use of HDAC inhibitors;

4. Previous use of PD-1/PD-L1/PD-L2/CTLA-4 inhibitors;

5. Allergy to related drug components;

6. Have a medical history of immune deficiency diseases, or organ transplantation;

7. Have active autoimmune diseases requiring treatment or a medical history of autoimmune diseases in the past 2 years;

8. Have uncontrolled or significant cardiovascular disease;

9. Abnormal liver function (total bilirubin > 1.5×upper limit of normal); Transaminases (ALT/AST) >2.5×upper limit of normal (>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine > 1.5×upper limit of normal);

10. Pregnancy ;

11. Receive any live or live attenuated vaccine within 4 weeks before enrollment;

12. Have serious diseases that may endanger the safety of patients, or affect patients to complete the research;

13. Any serious mental or cognitive disorder;

14. Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment;

15. Any other condition which is inappropriate for the study in the opinion of the investigators.