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.

Trial 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.

NCT ID: NCT05816694

Condition: Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma

Conditions: Official terms:
Thymoma
Thymus Neoplasms
Paclitaxel
Cyclophosphamide
Cisplatin
Epirubicin

Conditions: Keywords:
nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation
CEP (cisplatin, epirubicin,cyclophosphamide)
thymoma

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Participant)

Intervention:

Intervention type: Drug
Intervention name: NAB-Paclitaxel plus Cisplatin
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.
Arm group label: NAB-Paclitaxel

Intervention type: Drug
Intervention name: Cisplatin plus Epirubicin plus Cyclophosphamide
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 group label: CEP

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.

Criteria for 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；

Gender: All

Minimum age: 18 Years

Maximum age: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Yian Zhang

Address:
City: Shanghai
Zip: 200032
Country: China

Start date: April 30, 2023

Completion date: April 30, 2026

Lead sponsor:
Agency: Peng Liu
Agency class: Other

Source: Shanghai Zhongshan Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05816694