6 vs 3 Cycles of Neoadjuvant Chemotherapy for Potentially Resectable Locally Advanced Thymic Epithelial Tumors

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShanghai General Hospital, Shanghai Jiao Tong University School of Medicine

About this trial

This randomized controlled trial compares 6 versus 3 cycles of neoadjuvant chemotherapy in patients with potentially resectable locally advanced thymic epithelial tumors (TETs, WHO type AB/B/C, AJCC TNM stage IIIA-IVA). Patients are randomized 1:1 to receive either 6 or 3 cycles of chemotherapy (cisplatin + doxorubicin + cyclophosphamide for type B; nab-paclitaxel + carboplatin for type C thymoma/thymic carcinoma) every 3 weeks, followed by surgical resection when feasible. The primary endpoint is event-free survival (EFS). The study aims to determine whether extended neoadjuvant chemotherapy improves surgical outcomes and long-term survival in this rare malignancy.

Eligibility criteria

Qualifiers

Histologically or cytologically confirmed thymic epithelial tumor (thymoma or thymic carcinoma)

Locally advanced, potentially resectable disease (Masaoka-Koga stage III or IVA), as evaluated by a multidisciplinary team (MDT) including thoracic surgery and thoracic oncology

Age 18 to 65 years

Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Disqualifiers

Prior chemotherapy, targeted therapy, or immunotherapy for thymic epithelial tumor

Prior thoracic radiation therapy

Active autoimmune disease requiring systemic treatment within the past 2 years

Known hypersensitivity or contraindication to study drugs (cisplatin, epirubicin, etoposide, ifosfamide, or any component of these formulations)

Trial design

Treatments tested in this trial

  • Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)
  • nab-Paclitaxel and Carboplatin

Treatment groups

116 Participants
are divided into 2 treatment groups