Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm
NCT ID: NCT05113355
Last Updated: 2021-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
23 participants
INTERVENTIONAL
2021-11-17
2024-11-15
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chidamide + Sintilimab
Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months.
Chidamide
30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months.
Sintilimab
200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months.
Interventions
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Chidamide
30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months.
Sintilimab
200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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The First Affiliated Hospital of Xiamen University
OTHER
Harbin Medical University
OTHER
Peking Union Medical College Hospital
OTHER
Responsible Party
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Principal Investigators
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Chunmei Bai, M.D.
Role: PRINCIPAL_INVESTIGATOR
Peking Union Medical College Hospital
Locations
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The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Countries
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Central Contacts
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Facility Contacts
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Feng Ye, M.D.
Role: primary
Lei Liu, M.D.
Role: primary
Other Identifiers
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HS-3197D
Identifier Type: -
Identifier Source: org_study_id