Neuroendocrine TumorsPhase 2NCT05076786
Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Extrapulmonary Neuroendocrine Carcinoma
A Phase 2 study testing Chidamide and Etoposide + Cisplatin/Carboplatin in people with Neuroendocrine Tumors and Neuroendocrine Carcinoma, run by Peking Union Medical College Hospital at 3 sites in China.
Trial summary
The purpose of this study is to explore the efficacy and safety of chidamide combined with etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuroendocrine Tumors, Neuroendocrine Carcinoma
- What is being tested?
- Chidamide and Etoposide + Cisplatin/Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 3 sitesChina
- Study dates
- 27 Oct 2021to 15 Oct 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 locally advanced and metastatic extrapulmonary neuroendocrine carcinoma;
- No systematic treatments for neuroendocrine carcinoma are received before enrollment;
- ECOG ≤ 2;
- Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments;
- Absolute neutrophil count ≥ 1.5×109 / L, platelet count ≥ 100×109 / L, hemoglobin ≥ 90 g/L;
- Have ability to sign a written informed consent.
Who cannot join
- Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
- Previous use of HDAC inhibitors;
- Allergy to related drug components;
- Have a medical history of immune deficiency diseases, or organ transplantation;
- 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);
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- Pregnancy ;
- 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
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100032
Chunmei Bai, M.D., 69158706 ext. 86, baichunmei1964@163.com
- 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 Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Advanced Extrapulmonary Neuroendocrine Carcinoma: a Prospective, Multicenter, Single-arm, Phase 2 Clinical Study
The purpose of this study is to explore the efficacy and safety of chidamide combined with etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma.
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. Twelve patients with extrapulmonary neuroendocrine carcinoma will be enrolled in the first stage. If more than four complete or partial responses were seen at planned interim analysis, the additional 16 patients will be recruited in the second stage and a total of 28 patients will be treated.
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Carcinoma
- Being tested
- Chidamide, Etoposide + Cisplatin/Carboplatin
- Keywords
- Histone Deacetylase Inhibitors, Chidamide, Neuroendocrine Carcinoma
- 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
20mg, administered orally. Week 1/2: twice a week (d0, d4, d7, d11); Week 3: stop. Repeat every 3 weeks for 4-6 cycles.
Etoposide + Cisplatin/CarboplatinDrug
Also called EP/EC regimen
Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (75mg/m2; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles.
OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (25mg/m2; intravenous infusion; d1-3). Repeat every 3 weeks for 4-6 cycles.
OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Carboplatin (AUC=5; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles.
| Study group | Role | What they receive |
|---|---|---|
| Chidamide + Etoposide + Cisplatin/Carboplatin | Experimental | Experimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles. Receives: Drug: Chidamide; Drug: Etoposide + Cisplatin/Carboplatin |
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 posted13 Oct 2021
- Study start27 Oct 2021
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 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
- 28 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
- NCT05076786
- Sponsor's protocol ID
- HS-3125
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2021
- Last updated
- 3 Nov 2021
- Results posted
- No
- Data monitoring committee
- 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 3 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Plus Etoposide and Cisplatin/Carboplatin as First-line Treatment for Advanced Extrapulmonary Neuroendocrine Carcinoma: a Prospective, Multicenter, Single-arm, Phase 2 Clinical Study
- ClinicalTrials.gov ID
- NCT05076786
- Acronym / sponsor ID
- HS-3125
- Conditions
- Neuroendocrine Tumors, Neuroendocrine Carcinoma
- Keywords
- Histone Deacetylase Inhibitors, Chidamide, Neuroendocrine Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 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
- 27 Oct 2021 (actual)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 13 Oct 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 etoposide and cisplatin/carboplatin in the first-line treatment of advanced extrapulmonary neuroendocrine carcinoma.
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. Twelve patients with extrapulmonary neuroendocrine carcinoma will be enrolled in the first stage. If more than four complete or partial responses were seen at planned interim analysis, the additional 16 patients will be recruited in the second stage and a total of 28 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 + Etoposide + Cisplatin/Carboplatin | Experimental | Drug: Chidamide, Drug: Etoposide + Cisplatin/CarboplatinExperimental arm will be treated by chidamide combined with etoposide and cisplatin/carboplatin regimen for 4-6 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years;
- Histologically confirmed locally advanced and metastatic extrapulmonary neuroendocrine carcinoma;
- No systematic treatments for neuroendocrine carcinoma are received before enrollment;
- ECOG ≤ 2;
- Have at least one measurable lesion according to RECIST version 1.1, and the lesion has not received any local treatments;
Key exclusion criteria (11 listed)
- Have surgery or trauma within 4 weeks before enrollment, or are expected to receive surgical treatment;
- Previous use of HDAC inhibitors;
- Allergy to related drug components;
- Have a medical history of immune deficiency diseases, or organ transplantation;
- Have uncontrolled or significant cardiovascular disease;
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: Epidaza20mg, administered orally. Week 1/2: twice a week (d0, d4, d7, d11); Week 3: stop. Repeat every 3 weeks for 4-6 cycles. | Drug | Chidamide + Etoposide + Cisplatin/Carboplatin |
| Etoposide + Cisplatin/CarboplatinAlso: EP/EC regimenEtoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (75mg/m2; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles. OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (25mg/m2; intravenous infusion; d1-3). Repeat every 3 weeks for 4-6 cycles. OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Carboplatin (AUC=5; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles. | Drug | Chidamide + Etoposide + Cisplatin/Carboplatin |
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 3 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
3 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 Etoposide + Cisplatin/Carboplatin in people with Neuroendocrine Tumors and Neuroendocrine Carcinoma, run by Peking Union Medical College Hospital at 3 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 7 inclusion and 11 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 3 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 3 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 3 Nov 2021.