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.

NCT05816694 | Not Yet Recruiting Phase 2

• 1 other identifier: B2021-584R2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

nanoparticle albumin-bound (NAB)-paclitaxel plus Cisolation; CEP (cisplatin, epirubicin,cyclophosphamide); thymoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 3-year disease free survival (3yr-DFS)

  assessed up to 3 year

• overall survival rate (OS)

  assessed up to 3 year

• Incidence of adverse events

  assessed up to 1 year

• Surgical conversion success rate

  assessed up to 1 year

• Pathologic Complete Response（pCR）

  assessed up to 1 year

Study Arms (2)

CEP

ACTIVE COMPARATOR

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

NAB-Paclitaxel

EXPERIMENTAL

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

Interventions

NAB-Paclitaxel plus Cisplatin 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.

NAB-Paclitaxel

Cisplatin plus Epirubicin plus Cyclophosphamide 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.

CEP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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；

Sponsors & Collaborators

• Peng Liu: lead

Study Sites (1)

Yian Zhang

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Thymoma

Interventions

130-nm albumin-bound paclitaxel; Cisplatin; Epirubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Bei Xu, Ph.D

CONTACT

13817687547; xu.bei2@zs-hospital.sh.cn

Yue Fan, Ph.D

CONTACT

13901874150; fan.yue@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 27, 2023
• First Posted: April 18, 2023
• Study Start: April 30, 2023
• Primary Completion: October 30, 2024
• Study Completion: April 30, 2026
• Last Updated: April 18, 2023

Record last verified: 2023-04

Locations

CN (1)