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.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Histological or Cytological Confirmed Stage Ⅲ and Ⅳa Thymoma
• Intervention / Treatment: Drug: Cisplatin plus Epirubicin plus Cyclophosphamide; Drug: NAB-Paclitaxel plus Cisplatin

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Bei Xu, Ph.D; Phone Number: 13817687547; Email: xu.bei2@zs-hospital.sh.cn
• Study Contact Backup: Name: Yue Fan, Ph.D; Phone Number: 13901874150; Email: fan.yue@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Yian Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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；

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate (ORR)	the proportion of patients with complete response and partial response , using RECIST v 1.1	assessed up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival (3yr-DFS)	the percentage of Primary thymoma patients without recurrence/metastasis within 3 years in all enrolled patients	assessed up to 3 year
overall survival rate (OS)	from date of enrolment to date of death of any reason	assessed up to 3 year
Incidence of adverse events		assessed up to 1 year
Surgical conversion success rate	Following chemotherapy to evaluate proportion of patients underwent timely operation	assessed up to 1 year
Pathologic Complete Response（pCR）	the proportion of patients with complete response , using RECIST v 1.1	assessed up to 1 year
Main pathological Response	the proportion of patients with complete response and partial response , using RECIST v 1.1	assessed up to 1 year

Collaborators and Investigators

• Sponsor: Peng Liu

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2023
• Primary Completion (Anticipated): October 30, 2024
• Study Completion (Anticipated): April 30, 2026

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: April 17, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 18, 2023
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: thymoma; nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation; CEP (cisplatin, epirubicin,cyclophosphamide)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Neoplasms by Site; Thoracic Neoplasms; Neoplasms, Complex and Mixed; Thymoma; Thymus Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Paclitaxel; Cisplatin; Epirubicin
• Other Study ID Numbers: B2021-584R2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes