Overview

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

Status:
Not yet recruiting
Trial end date:
2026-04-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peng Liu
Treatments:
Cisplatin
Cyclophosphamide
Epirubicin
Paclitaxel
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;