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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05113355
• Other study ID #: HS-3197D
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2021
• Est. completion date: November 15, 2024

Study information

• Verified date: October 2021
• Source: Peking Union Medical College Hospital
• Contact: Chunmei Bai, M.D.
• Phone: 69158706
• Email: baichunmei1964[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Neuroendocrine
• Neoplasms
• Neuroendocrine Carcinoma
• Neuroendocrine Neoplasm
• Neuroendocrine Tumors

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (3)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	Harbin Medical University, The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

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