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.
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
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)
Parallel
Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)
DrugChemotherapy regimen for WHO type B thymoma. Cyclophosphamide 500 mg/m2 IV + Doxorubicin 50 mg/m2 IV + Cisplatin 50 mg/m2 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery.
nab-Paclitaxel and Carboplatin
DrugChemotherapy regimen for thymic carcinoma. nab-Paclitaxel 260 mg/m2 IV + Carboplatin AUC 5 IV, administered every 3 weeks. Experimental arm receives 6 cycles; Control arm receives 3 cycles prior to surgery.
Event-Free Survival (EFS)
EFS is defined as the time from randomization to the first occurrence of any of the following events: disease progression precluding surgery, incomplete resection (R1/R2), local or distant recurrence after surgery, or death from any cause.
Objective Response Rate (ORR)
Proportion of participants achieving complete response (CR) or partial response (PR) per RECIST v1.1 criteria after neoadjuvant chemotherapy.
3-Year Event-Free Survival Rate
Proportion of participants who remain free of events (disease progression, incomplete resection, recurrence, or death) at 3 years after randomization.
R0 Resection Rate
Proportion of participants achieving complete (R0) resection, defined as microscopically negative surgical margins at the time of surgery.
Pathological Complete Response (pCR) Rate
Proportion of participants achieving pathological complete response (pCR), defined as no viable tumor cells in the surgical resection specimen, as assessed by central pathology review.
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