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.

Sponsor

Peng Liu (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05816694

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma	Drug: NAB-Paclitaxel plus Cisplatin Drug: Cisplatin plus Epirubicin plus Cyclophosphamide	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Apr 30, 2023

Anticipated Primary Completion Date :

Oct 30, 2024

Anticipated Study Completion Date :

Apr 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CEP 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.	Drug: Cisplatin plus Epirubicin plus Cyclophosphamide 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.
Experimental: NAB-Paclitaxel 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.	Drug: NAB-Paclitaxel plus Cisplatin 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.

Arm

Intervention/Treatment

Active Comparator: CEP

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.

Drug: Cisplatin plus Epirubicin plus Cyclophosphamide

Experimental: NAB-Paclitaxel

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.

Drug: NAB-Paclitaxel plus Cisplatin

Outcome Measures

Primary Outcome Measures

overall response rate (ORR) [assessed up to 1 year]
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) [assessed up to 3 year]
the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients
overall survival rate (OS) [assessed up to 3 year]
from date of enrolment to date of death of any reason
Incidence of adverse events [assessed up to 1 year]
Surgical conversion success rate [assessed up to 1 year]
Following chemotherapy to evaluate proportion of patients underwent timely operation
Pathologic Complete Response（pCR） [assessed up to 1 year]
the proportion of patients with complete response , using RECIST v 1.1
Main pathological Response [assessed up to 1 year]
the proportion of patients with complete response and partial response , using RECIST v 1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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；