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

  • STATUS
    Recruiting
  • End date
    Nov 15, 2024
  • participants needed
    23
  • sponsor
    Peking Union Medical College Hospital
Updated on 2 December 2021
platelet count
measurable disease
neutrophil count
pd-l1
tumor progression

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.

Details
Condition neuroendocrine tumors, Neurectoderma, Neuroendocrine carcinoma, neuroendocrine tumour, Neuroendocrine Tumor Grade 3, Neuroendocrine Carcinoma, Neuroectodermal Tumor, Neuroendocrine Tumor
Treatment Chidamide, Sintilimab
Clinical Study IdentifierNCT05113355
SponsorPeking Union Medical College Hospital
Last Modified on2 December 2021

Eligibility

Yes No Not Sure

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 1.5109 / L, platelet count 100109 / 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 > 1.5upper limit of normal); Transaminases (ALT/AST) >2.5upper limit of normal (>5x upper limit of normal for patients with liver metastases), abnormal renal function (serum creatinine > 1.5upper 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
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