Histological or Cytological Confirmed Stage Ⅲ and Ⅳa ThymomaPhase 2NCT05816694
The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train.
A Phase 2 study testing NAB-Paclitaxel plus Cisplatin and Cisplatin plus Epirubicin plus Cyclophosphamide in people with Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma, run by Peng Liu at 1 site in China.
Trial summary
This study for a single-center prospective phase II randomized controlled train to assess the efficacy and safety of Induction therapy on thymoma .Methods patients with thymoma (stage Ⅲ and stage Ⅳa) were treated with 2 cycles of (NAB)-paclitaxel plus Cisolation (Paclitaxel For Injection(Aalbumin Bound）125 mg/m2 Day 1… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma
- What is being tested?
- NAB-Paclitaxel plus Cisplatin and Cisplatin plus Epirubicin plus Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2023to 30 Apr 2026
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years；
- Histological or cytological confirmed stage Ⅲ and Ⅳa thymoma;
- PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion；
- Life expectancy >12months；
- ECOG PS 0-1；
- --Patients with thymoma metastasis；
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- No found the other malignant tumors (expect has been controlled Carcinoma in situ of the cervix and Basal Cell Carcinoma）；
- Informed consent was signed before the study began；
- Normal Bone marrow hematopoiesis and renal function，Blood routine: absolute neutrophil count≥1,500/uL，Hb>8.0g/dL，PLT>80×10*9/L，AST≤ 1.5 times the upper limit of normal，TBIL ≤1.5 times the upper limit of normal，calculated creatinine clearance ≤110µmol/L，blood urea nitrogen≤7.1mmol/L；
- Cardiac function: LVEF≥55%；
- Patients who have not active bleeding or coagulopathy before enrollment；
Who cannot join
- -Patients who have been found thymoma metastasis；
- Patients with uncontrolled lung disease, Serious infection,active peptic ulcers, coagulation diaorders, Uncontrolled severe diabetes, connective tissue diseases or Bone marrow suppression and Induction therapy for intolerance；
- Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE version 5.0 )；
- Significant organ dysfunction: such as respiratory failure, NYHA classification Class III or IV, chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure（SBP> 180 mmHg or DBP> 100mmHg）；
- Pregnant and lactating women；
- patients without undergo preoperative puncture biopsy or induction therapy；
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- Patients with active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response；
- Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study；
- Known HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded；
- Patients with uncontrollable Stable myasthenia gravis or uncontrollable Serious autoimmune disease such as fulminant DIC；
- Patients who are known to be allergic or intolerant to chemotherapy drugs；
- severe-trauma；
- Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study；
Trial locations and contacts
1 site in 1 country.
About this study
This study for a single-center prospective phase II randomized controlled train to assess the efficacy and safety of Induction therapy on thymoma .Methods patients with thymoma (stage Ⅲ and stage Ⅳa) were treated with 2 cycles of (NAB)-paclitaxel plus Cisolation (Paclitaxel For Injection(Aalbumin Bound）125 mg/m2 Day 1 、Day8 ,Cisplatin 75 mg/m2 Day 1of each 3-week cycle）or CEP(cisplatin 50 mg/m2 Day 1, epirubicin 75 mg/m2 Day 1,cyclophosphamide 500 mg/m2 Day 1 of each 3-week cycle). Following chemotherapy to evaluate the patient for operation. Patients without undergo surgery will be continued to receive 2 cycles of Primary chemotherap.
- Being tested
- NAB-Paclitaxel plus Cisplatin, Cisplatin plus Epirubicin plus Cyclophosphamide
- Keywords
- nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation, CEP (cisplatin, epirubicin,cyclophosphamide), thymoma
- Medical subject headings
- Thymoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NAB-Paclitaxel plus CisplatinDrug
NAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.
Cisplatin plus Epirubicin plus CyclophosphamideDrug
Cisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study.
| Study group | Role | What they receive |
|---|---|---|
| CEP | Active comparator | Cisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study. Receives: Drug: Cisplatin plus Epirubicin plus Cyclophosphamide |
| NAB-Paclitaxel | Experimental | NAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study. Receives: Drug: NAB-Paclitaxel plus Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall response rate (ORR)
the proportion of patients with complete response and partial response , using RECIST v 1.1
Measured: assessed up to 1 year
Secondary outcomes (6)
3-year disease free survival (3yr-DFS)
the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients
Measured: assessed up to 3 year
overall survival rate (OS)
from date of enrolment to date of death of any reason
Measured: assessed up to 3 year
Incidence of adverse events
Measured: assessed up to 1 year
Surgical conversion success rate
Following chemotherapy to evaluate proportion of patients underwent timely operation
Measured: assessed up to 1 year
Pathologic Complete Response（pCR）
the proportion of patients with complete response , using RECIST v 1.1
Measured: assessed up to 1 year
Main pathological Response
the proportion of patients with complete response and partial response , using RECIST v 1.1
Measured: assessed up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion30 Oct 2024 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histological or Cytological Confirmed Stage Ⅲ and Ⅳa ThymomaStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Liu, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05816694
- Sponsor's protocol ID
- B2021-584R2
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Nanoparticle Albumin-bound (NAB)-Paclitaxel Plus Cisolation Versus CEP (Cisplatin, Epirubicin,Cyclophosphamide) in Induction Therapy for Thymoma: a Study for a Single-center Prospective Phase II Randomized Controlled Train.
- ClinicalTrials.gov ID
- NCT05816694
- Acronym / sponsor ID
- B2021-584R2
- Keywords
- nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation, CEP (cisplatin, epirubicin,cyclophosphamide), thymoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peng LiuUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Oct 2024 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 18 Apr 2023 (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.
This study for a single-center prospective phase II randomized controlled train to assess the efficacy and safety of Induction therapy on thymoma .Methods patients with thymoma (stage Ⅲ and stage Ⅳa) were treated with 2 cycles of (NAB)-paclitaxel plus Cisolation (Paclitaxel For Injection(Aalbumin Bound）125 mg/m2 Day 1 、Day8 ,Cisplatin 75 mg/m2 Day 1of each 3-week cycle）or CEP(cisplatin 50 mg/m2 Day 1, epirubicin 75 mg/m2 Day 1,cyclophosphamide 500 mg/m2 Day 1 of each 3-week cycle). Following chemotherapy to evaluate the patient for operation. Patients without undergo surgery will be continued to receive 2 cycles of Primary chemotherap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEP | Active comparator | Drug: Cisplatin plus Epirubicin plus CyclophosphamideCisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study. |
| NAB-Paclitaxel | Experimental | Drug: NAB-Paclitaxel plus CisplatinNAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 18-75 years；
- Histological or cytological confirmed stage Ⅲ and Ⅳa thymoma;
- PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion；
- Life expectancy >12months；
- ECOG PS 0-1；
Key exclusion criteria (13 listed)
- -Patients who have been found thymoma metastasis；
- Patients with uncontrolled lung disease, Serious infection,active peptic ulcers, coagulation diaorders, Uncontrolled severe diabetes, connective tissue diseases or Bone marrow suppression and Induction therapy for intolerance；
- Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE version 5.0 )；
- Significant organ dysfunction: such as respiratory failure, NYHA classification Class III or IV, chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure（SBP> 180 mmHg or DBP> 100mmHg）；
- Pregnant and lactating women；
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 |
|---|---|---|
| NAB-Paclitaxel plus CisplatinNAB-Paclitaxel will be administered as 125 mg/m2 IV infusion on Day 1 、Day8 of each 3-week cycle. Cisplatin will be administered as 75 mg/m2 IV infusion on Day 1 of each 3-week cycle. Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study. | Drug | NAB-Paclitaxel |
| Cisplatin plus Epirubicin plus CyclophosphamideCisplatin was administered as 50 mg/m2 IV infusion on Day 1; Epirubicin was administered as 75 mg/m2 IV infusion on Day 1; Cyclophosphamide was administered as 500 mg/m2IV infusion on Day 1 of each 3-week cycle.Patients will receive maximum of 4 cycles if they do not meet the criteria for removal from the study. | Drug | CEP |
Primary outcome
overall response rate (ORR)
Time frame: assessed up to 1 year
the proportion of patients with complete response and partial response , using RECIST v 1.1
6 secondary outcomes
3-year disease free survival (3yr-DFS)
Time frame: assessed up to 3 year
overall survival rate (OS)
Time frame: assessed up to 3 year
Incidence of adverse events
Time frame: assessed up to 1 year
Surgical conversion success rate
Time frame: assessed up to 1 year
Pathologic Complete Response（pCR）
Time frame: assessed up to 1 year
Main pathological Response
Time frame: assessed up to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NAB-Paclitaxel plus Cisplatin and Cisplatin plus Epirubicin plus Cyclophosphamide in people with Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma, run by Peng Liu at 1 site 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 11 inclusion and 13 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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Bei Xu, Ph.D (13817687547, xu.bei2@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall response rate (ORR) (time frame: assessed up to 1 year). 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 18 Apr 2023.