Neuroendocrine Tumors Clinical Trial
Official title:
Chidamide and Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Study
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.
Status | Recruiting |
Enrollment | 23 |
Est. completion date | November 15, 2024 |
Est. primary completion date | November 15, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
China | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian |
Lead Sponsor | Collaborator |
---|---|
Peking Union Medical College Hospital | Harbin Medical University, The First Affiliated Hospital of Xiamen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate (ORR) | Percentage of participants with complete response and partial response, assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 | Up to 2 years | |
Secondary | Disease Control Rate (DCR) | Percentage of participants with complete response, partial response, and stable disease assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1 | Up to 2 years | |
Secondary | Progression-free Survival (PFS) | Time from the date of enrollment until progression or death, whichever is first met | Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years | |
Secondary | Overall Survival (OS) | Time from the date of enrollment until death | Time from the date of enrollment to the earliest of documented death, assessed up to 3 years | |
Secondary | Treatment-related Adverse Events (Safety) | Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03) | Up to 2 years |
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