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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.

Primary Purpose

Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
NAB-Paclitaxel plus Cisplatin
Cisplatin plus Epirubicin plus Cyclophosphamide
Sponsored by
Peng Liu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma focused on measuring nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation, CEP (cisplatin, epirubicin,cyclophosphamide), thymoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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; 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; Exclusion Criteria: -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; 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;

Sites / Locations

  • Yian Zhang

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CEP

NAB-Paclitaxel

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

overall response rate (ORR)
the proportion of patients with complete response and partial response , using RECIST v 1.1

Secondary Outcome Measures

3-year disease free survival (3yr-DFS)
the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients
overall survival rate (OS)
from date of enrolment to date of death of any reason
Incidence of adverse events
Surgical conversion success rate
Following chemotherapy to evaluate proportion of patients underwent timely operation
Pathologic Complete Response(pCR)
the proportion of patients with complete response , using RECIST v 1.1
Main pathological Response
the proportion of patients with complete response and partial response , using RECIST v 1.1

Full Information

First Posted
March 27, 2023
Last Updated
April 17, 2023
Sponsor
Peng Liu
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1. Study Identification

Unique Protocol Identification Number
NCT05816694
Brief 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.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
October 30, 2024 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Peng Liu

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief 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 、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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma
Keywords
nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation, CEP (cisplatin, epirubicin,cyclophosphamide), thymoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CEP
Arm Type
Active Comparator
Arm Description
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.
Arm Title
NAB-Paclitaxel
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
NAB-Paclitaxel plus Cisplatin
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Cisplatin plus Epirubicin plus Cyclophosphamide
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall response rate (ORR)
Description
the proportion of patients with complete response and partial response , using RECIST v 1.1
Time Frame
assessed up to 1 year
Secondary Outcome Measure Information:
Title
3-year disease free survival (3yr-DFS)
Description
the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients
Time Frame
assessed up to 3 year
Title
overall survival rate (OS)
Description
from date of enrolment to date of death of any reason
Time Frame
assessed up to 3 year
Title
Incidence of adverse events
Time Frame
assessed up to 1 year
Title
Surgical conversion success rate
Description
Following chemotherapy to evaluate proportion of patients underwent timely operation
Time Frame
assessed up to 1 year
Title
Pathologic Complete Response(pCR)
Description
the proportion of patients with complete response , using RECIST v 1.1
Time Frame
assessed up to 1 year
Title
Main pathological Response
Description
the proportion of patients with complete response and partial response , using RECIST v 1.1
Time Frame
assessed up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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; 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; Exclusion Criteria: -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; 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bei Xu, Ph.D
Phone
13817687547
Email
xu.bei2@zs-hospital.sh.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yue Fan, Ph.D
Phone
13901874150
Email
fan.yue@zs-hospital.sh.cn
Facility Information:
Facility Name
Yian Zhang
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China

12. IPD Sharing Statement

Learn more about this trial

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.

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