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

Phase 2

Recruiting

• Conditions: Neuroendocrine Tumors; Neuroendocrine Tumor Grade 3; Neuroendocrine Carcinoma; Neuroendocrine Neoplasm
• Interventions: Drug: Chidamide; Drug: Sintilimab

• Registration Number: NCT05113355
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed 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 respons...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2021-11-02
• Study First Posted: 2021-11-09
• Study Start: 2021-11-17
• Last Update Submitted: 2021-11-22
• Last Update Posted: 2021-11-24
• Primary Completion: 2022-11-15
• Study Completion: 2024-11-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 23

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Chidamide + Sintilimab	Sintilimab	Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months.
Chidamide + Sintilimab	Chidamide	Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	Up to 2 years	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

Secondary Outcome Measures

Name	Time	Method
Disease Control Rate (DCR)	Up to 2 years	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
Progression-free Survival (PFS)	Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years	Time from the date of enrollment until progression or death, whichever is first met
Overall Survival (OS)	Time from the date of enrollment to the earliest of documented death, assessed up to 3 years	Time from the date of enrollment until death
Treatment-related Adverse Events (Safety)	Up to 2 years	Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03)

Trial Locations

Locations (2)

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

Harbin Medical University Cancer Hospital; 🇨🇳 Harbin, Heilongjiang, China