Clinical trial NCT05816694: 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
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma
Keywords: nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation
CEP (cisplatin, epirubicin,cyclophosphamide)
thymoma
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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；

Primary outcomes:
measure: overall response rate (ORR)
timeFrame: assessed up to 1 year
Secondary outcomes:
measure: 3-year disease free survival (3yr-DFS)
timeFrame: assessed up to 3 year
measure: overall survival rate (OS)
timeFrame: assessed up to 3 year
measure: Incidence of adverse events
timeFrame: assessed up to 1 year
measure: Surgical conversion success rate
timeFrame: assessed up to 1 year
measure: Pathologic Complete Response（pCR）
timeFrame: assessed up to 1 year
measure: Main pathological Response
timeFrame: assessed up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yian Zhang
state: Shanghai
Study officials:
References: