NCT05816694

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.

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peng Liu · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2023-04-30
• Primary completion: 2024-10-30
• Completion: 2026-04-30
• First posted: 2023-04-18
• Last updated: 2023-04-18

Locations

1 site across 1 country: China