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

Primary Purpose

Neuroendocrine Tumors, Neuroendocrine Tumor Grade 3, Neuroendocrine Carcinoma

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Chidamide

Sintilimab

About this trial

This is an interventional treatment trial for Neuroendocrine Tumors focused on measuring Histone Deacetylase Inhibitors, Chidamide, Neuroendocrine Neoplasm, PD-1, Sintilimab

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 18 years;
Histologically confirmed advanced and metastatic high-grade neuroendocrine neoplasm;
Receive ≤ 2 types of chemotherapy for high-grade neuroendocrine tumors and had tumor progression;
ECOG ≤ 2;
Have at least one measurable lesion according to RECIST version 1.1;
Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
Provide tumor samples for pathological diagnosis and PD-L1 biomarker detection;
Have ability to sign a written informed consent.

Exclusion Criteria:

Small cell lung cancer;
Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
Previous use of HDAC inhibitors;
Previous use of PD-1/PD-L1/PD-L2/CTLA-4 inhibitors;
Allergy to related drug components;
Have a medical history of immune deficiency diseases, or organ transplantation;
Have active autoimmune diseases requiring treatment or a medical history of autoimmune diseases in the past 2 years;
Have uncontrolled or significant cardiovascular disease;
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);
Pregnancy ;
Receive any live or live attenuated vaccine within 4 weeks before enrollment;
Have serious diseases that may endanger the safety of patients, or affect patients to complete the research;
Any serious mental or cognitive disorder;
Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment;
Any other condition which is inappropriate for the study in the opinion of the investigators.

Sites / Locations

The First Affiliated Hospital of Xiamen UniversityRecruiting
Harbin Medical University Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chidamide + Sintilimab

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Progression-free Survival (PFS)

Time from the date of enrollment until progression or death, whichever is first met

Overall Survival (OS)

Time from the date of enrollment until death

Treatment-related Adverse Events (Safety)

Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03)

Full Information

NCT ID

NCT05113355

First Posted

November 2, 2021

Last Updated

November 22, 2021

Sponsor

Peking Union Medical College Hospital

Collaborators

The First Affiliated Hospital of Xiamen University, Harbin Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05113355

Brief Title

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

Official Title

Chidamide and Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Recruiting

Study Start Date

November 17, 2021 (Actual)

Primary Completion Date

November 15, 2022 (Anticipated)

Study Completion Date

November 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Peking Union Medical College Hospital

Collaborators

The First Affiliated Hospital of Xiamen University, Harbin Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuroendocrine Tumors, Neuroendocrine Tumor Grade 3, Neuroendocrine Carcinoma, Neuroendocrine Neoplasm

Keywords

Histone Deacetylase Inhibitors, Chidamide, Neuroendocrine Neoplasm, PD-1, Sintilimab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

23 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Chidamide + Sintilimab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Chidamide

Other Intervention Name(s)

Epidaza

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Other Intervention Name(s)

Tyvyt

Intervention Description

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

Primary Outcome Measure Information:

Title

Objective Response Rate (ORR)

Description

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

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

Disease Control Rate (DCR)

Description

Time Frame

Up to 2 years

Title

Progression-free Survival (PFS)

Description

Time from the date of enrollment until progression or death, whichever is first met

Time Frame

Time from the date of enrollment to the earliest of documented disease progression or death, assessed up to 2 years

Title

Overall Survival (OS)

Description

Time from the date of enrollment until death

Time Frame

Time from the date of enrollment to the earliest of documented death, assessed up to 3 years

Title

Treatment-related Adverse Events (Safety)

Description

Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03)

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 18 years; Histologically confirmed advanced and metastatic high-grade neuroendocrine neoplasm; Receive ≤ 2 types of chemotherapy for high-grade neuroendocrine tumors and had tumor progression; ECOG ≤ 2; Have at least one measurable lesion according to RECIST version 1.1; Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L; Provide tumor samples for pathological diagnosis and PD-L1 biomarker detection; Have ability to sign a written informed consent. Exclusion Criteria: Small cell lung cancer; Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment; Previous use of HDAC inhibitors; Previous use of PD-1/PD-L1/PD-L2/CTLA-4 inhibitors; Allergy to related drug components; Have a medical history of immune deficiency diseases, or organ transplantation; Have active autoimmune diseases requiring treatment or a medical history of autoimmune diseases in the past 2 years; Have uncontrolled or significant cardiovascular disease; 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); Pregnancy ; Receive any live or live attenuated vaccine within 4 weeks before enrollment; Have serious diseases that may endanger the safety of patients, or affect patients to complete the research; Any serious mental or cognitive disorder; Patients are currently enrolled in another drug clinical trial within 4 weeks prior to enrollment; Any other condition which is inappropriate for the study in the opinion of the investigators.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chunmei Bai, M.D.

Phone

69158706

Ext

baichunmei1964@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chunmei Bai, M.D.

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Affiliated Hospital of Xiamen University

City

Xiamen

State/Province

Fujian

ZIP/Postal Code

361003

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Feng Ye, M.D.

Facility Name

Harbin Medical University Cancer Hospital

City

Harbin

State/Province

Heilongjiang

ZIP/Postal Code

150040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lei Liu, M.D.

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Individual participant data are not available to others.

Learn more about this trial

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

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