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

NCT05113355 | Unknown Phase 2

• 1 other identifier: HS-3197D
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Neuroendocrine Tumors; Neuroendocrine Tumor Grade 3; Neuroendocrine Carcinoma; Neuroendocrine Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Disease Control Rate (DCR)

  Up to 2 years

• Progression-free Survival (PFS)

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

• Overall Survival (OS)

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

• Treatment-related Adverse Events (Safety)

  Up to 2 years

Study Arms (1)

Chidamide + Sintilimab

EXPERIMENTAL

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

Drug: Chidamide; Drug: Sintilimab

Interventions

Chidamide DRUG

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

Also known as: Epidaza

Chidamide + Sintilimab

Sintilimab DRUG

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

Also known as: Tyvyt

Chidamide + Sintilimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead
• The First Affiliated Hospital of Xiamen University: collaborator
• Harbin Medical University: collaborator

Study Sites (2)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361003, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150040, China

RECRUITING

MeSH Terms

Conditions

Neuroendocrine Tumors; Carcinoma, Neuroendocrine

Interventions

N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide; sintilimab

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial

Study Officials

• Chunmei Bai, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunmei Bai, M.D.

CONTACT

69158706; baichunmei1964@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 9, 2021
• Study Start: November 17, 2021
• Primary Completion: November 15, 2022
• Study Completion: November 15, 2024
• Last Updated: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)