Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma | Thymoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin plus Epirubicin plus Cyclophosphamide | Drug | — | UNRESOLVED |
| NAB-Paclitaxel plus Cisplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- CEP
- 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.
- interventionNames
- Drug: Cisplatin plus Epirubicin plus Cyclophosphamide
- type
- EXPERIMENTAL
- label
- NAB-Paclitaxel
- 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.
- interventionNames
- Drug: NAB-Paclitaxel plus Cisplatin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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;
References
Publications (0)
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