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

November 22, 2021 updated by: Peking Union Medical College Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

23

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Xiamen, Fujian, China, 361003
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Feng Ye, M.D.
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150040
        • Recruiting
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Lei Liu, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chidamide + Sintilimab
Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months.
Drug: Chidamide
30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months.
Other Names:
  • Epidaza
Drug: Sintilimab
200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months.
Other Names:
  • Tyvyt

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: 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
Up to 2 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Collaborators

Harbin Medical University
The First Affiliated Hospital of Xiamen University

Investigators

  • Principal Investigator: Chunmei Bai, M.D., Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2021

Primary Completion (Anticipated)

November 15, 2022

Study Completion (Anticipated)

November 15, 2024

Study Registration Dates

First Submitted

November 2, 2021

First Submitted That Met QC Criteria

November 2, 2021

First Posted (Actual)

November 9, 2021

Study Record Updates

Last Update Posted (Actual)

November 24, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-3197D

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data are not available to others.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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