Neuroendocrine TumorsPhase 2NCT05113355
Chidamide Plus Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm
A Phase 2 study testing Chidamide and Sintilimab in people with Neuroendocrine Tumors and Neuroendocrine Tumor Grade 3, run by Peking Union Medical College Hospital at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 3, Neuroendocrine Carcinoma
- What is being tested?
- Chidamide and Sintilimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 2 sitesChina
- Study dates
- 17 Nov 2021to 15 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150040
Lei Liu, M.D.
- Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361003
Feng Ye, M.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 3, Neuroendocrine Carcinoma, Neuroendocrine Neoplasm
- Being tested
- Chidamide, Sintilimab
- Keywords
- Histone Deacetylase Inhibitors, Chidamide, Neuroendocrine Neoplasm, PD-1, Sintilimab
- Medical subject headings
- Neuroendocrine Tumors, Carcinoma, Neuroendocrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChidamideDrug
Also called Epidaza
30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months.
SintilimabDrug
Also called Tyvyt
200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide + Sintilimab | Experimental | Experimental arm will be treated by chidamide combined with sintilimab for up to 24 months. Receives: Drug: Chidamide; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 years
Secondary outcomes (4)
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
Measured: Up to 2 years
Progression-free Survival (PFS)
Time from the date of enrollment until progression or death, whichever is first met
Measured: 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 until death
Measured: Time from the date of enrollment to the earliest of documented death, assessed up to 3 years
Treatment-related Adverse Events (Safety)
Frequency and grade of adverse events (the grade of adverse events is assessed according to CTCAE v4.03)
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start17 Nov 2021
- Primary completion15 Nov 2022 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuroendocrine TumorsStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, Harbin Medical University
- Responsible party
- Sponsor
- Investigators
- Chunmei Bai, M.D., Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113355
- Sponsor's protocol ID
- HS-3197D
- Status last verified
- Oct 2021
- First submitted
- 2 Nov 2021
- Last updated
- 24 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not available to others.
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide and Sintilimab for Chemotherapy-refractory Advanced High-grade Neuroendocrine Neoplasm: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT05113355
- Acronym / sponsor ID
- HS-3197D
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Tumor Grade 3, Neuroendocrine Carcinoma, Neuroendocrine Neoplasm
- Keywords
- Histone Deacetylase Inhibitors, Chidamide, Neuroendocrine Neoplasm, PD-1, Sintilimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Xiamen University, Harbin Medical University
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 15 Nov 2022 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 9 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide + Sintilimab | Experimental | Drug: Chidamide, Drug: SintilimabExperimental arm will be treated by chidamide combined with sintilimab for up to 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChidamideAlso: Epidaza30mg; administered orally; twice a week (d1, d4, d8, d11, d15, d18). Repeat every 3 weeks for up to 24 months. | Drug | Chidamide + Sintilimab |
| SintilimabAlso: Tyvyt200mg; intravenous infusion; d1. Repeat every 3 weeks for up to 24 months. | Drug | Chidamide + Sintilimab |
Primary outcome
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
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: 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
Overall Survival (OS)
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2021.
- Individual participant dataSharing planned: No. Individual participant data are not available to others.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunmei Bai, M.D. principal investigator
Peking Union Medical College Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chidamide and Sintilimab in people with Neuroendocrine Tumors and Neuroendocrine Tumor Grade 3, run by Peking Union Medical College Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunmei Bai, M.D. (69158706 ext. 86, baichunmei1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2021.