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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05113355
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Peking Union Medical College Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Chunmei Bai, M.D.
Principal Investigator Affiliation	Peking Union Medical College Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroendocrine Tumors, Neuroendocrine Tumor Grade 3, Neuroendocrine Carcinoma, Neuroendocrine Neoplasm

Additional Details

This study is a single-arm, multi-center, two-stage, phase II clinical trial conducted in China. This study adopts Simon's two-stage design, and the inclusion criteria and exclusion criteria of the two stages were consistent. Six patients with high-grade neuroendocrine neoplasm will be enrolled in the first stage. If more than one complete or partial responses were seen at planned interim analysis, the additional 17 patients will be recruited in the second stage and a total of 23 patients will be treated.

Arms & Interventions

Arms

Experimental: Chidamide + Sintilimab

Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months.

Interventions

Drug: - Chidamide

30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months.

Drug: - Sintilimab

200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Xiamen, Fujian, China

Status

Recruiting

Address

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003

Site Contact

Feng Ye, M.D.

[email protected]

69158706

Harbin, Heilongjiang, China

Status

Recruiting

Address

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150040

Site Contact

Lei Liu, M.D.

[email protected]

69158706

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