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

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-30
• Study Completion Date: 2026-04-30

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.

Conditions

Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CEP

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.

Group Type: ACTIVE_COMPARATOR

Cisplatin plus Epirubicin plus Cyclophosphamide

Intervention Type: DRUG

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.

NAB-Paclitaxel

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.

Group Type: EXPERIMENTAL

NAB-Paclitaxel plus Cisplatin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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；

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peng Liu

OTHER

Sponsor Role: lead

Responsible Party

Peng Liu

Director

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Yian Zhang

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Bei Xu, Ph.D

Role: CONTACT

xu.bei2@zs-hospital.sh.cn

13817687547

Yue Fan, Ph.D

Role: CONTACT

fan.yue@zs-hospital.sh.cn

13901874150

Other Identifiers

B2021-584R2

Identifier Type: -

Identifier Source: org_study_id