Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Phase
Phase 2/3
Started
2026-03
Last updated
2026-03-11
Condition(s) studied
Thymoma and Thymic Carcinoma
Investigational drug(s) / intervention(s)
Cyclophosphamide, Doxorubicin, and Cisplatin (CAP)nab-Paclitaxel and Carboplatin
Cyclophosphamide, Doxorubicin, and Cisplatin (CAP): Chemotherapy 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: Chemotherapy 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 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
* Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L
* Adequate liver function: total bilirubin ≤1.5× upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN
* Adequate renal function: creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
* No prior systemic anticancer therapy for thymic epithelial tumor
* At least one measurable lesion per RECIST v1.1
* Willing to accept randomization and able to comply with study procedures
* Written informed consent obtained prior to any study-related procedures
Exclusion Criteria:
* 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)
* Severe cardiac dysfunction: New York Heart Association (NYHA) class III or IV heart failure, or left ventricular ejection fraction (LVEF) \<50%
* Active hepatitis B (HBsAg positive with HBV DNA ≥2000 IU/mL), active hepatitis C, or known HIV infection
* Pregnancy or lactation; women of childbearing potential unwilling to use adequate contraception
* Other malignancy within 5 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or carcinoma in situ of the cervix
* Uncontrolled active infection requiring systemic therapy
* Any condition that, in the investigator's judgment, would preclude safe participation in the study
Primary outcome measure(s)
Event-Free Survival (EFS) — 3 years from randomization 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.
Trial sites (1)
Facility
City
Region
Status
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
Shanghai Municipality
More Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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