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.

Phase 2

Not yet recruiting

• Conditions: Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma
• Interventions: Drug: NAB-Paclitaxel plus Cisplatin; Drug: Cisplatin plus Epirubicin plus Cyclophosphamide

• Registration Number: NCT05816694
• Lead Sponsor: Peng Liu

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-17
• Last Update Submitted: 2023-04-17
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Study Start: 2023-04-30
• Primary Completion: 2024-10-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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；

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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；

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NAB-Paclitaxel	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.
CEP	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of adverse events	assessed up to 1 year
Main pathological Response	assessed up to 1 year	the proportion of patients with complete response and partial response , using RECIST v 1.1
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
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
overall survival rate (OS)	assessed up to 3 year	from date of enrolment to date of death of any reason

Trial Locations

Locations (1)

Yian Zhang; 🇨🇳 Shanghai, Shanghai, China