6 vs 3 Cycles of Neoadjuvant Chemotherapy for Potentially Resectable Locally Advanced Thymic Epithelial Tumors
Run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · NCT07463313 · Data updated 2026-11-12
Not yet open. This study is not taking new participants. Its registered completion date is 2029-03.
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 …
Quick facts
| Phase | Phase 2/3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 116 (estimated) |
| Sponsor | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | Cyclophosphamide, Doxorubicin, and Cisplatin (CAP), nab-Paclitaxel and Carboplatin |
| Locations | 1 site (China) |
| Trial ID | NCT07463313 on ClinicalTrials.gov |
What this trial studies
Thymic epithelial tumors (TETs) are rare mediastinal malignancies. Locally advanced, potentially resectable TETs present a significant clinical challenge, with limited prospective data on optimal neoadjuvant chemotherapy duration. Retrospective data from Shanghai General Hospital suggest that 6 cycles of neoadjuvant chemotherapy may yield higher objective response rates (75% vs 33.3%) and R0 resection rates (68.75% vs 33.33%) compared to 3 cycles. This is a single-center, prospective, open-label, randomized controlled trial. Eligible patients are adults (18-65 years) with histologically confirmed WHO type AB, B1, B2, B3 thymoma or thymic carcinoma (type C), AJCC TNM stage IIIA-IVA, deemed potentially resectable by multidisciplinary team (MDT) evaluation, ECOG PS 0-1, with adequate organ function, no prior anti-tumor therapy. Randomization: 1:1, stratified by histological subtype (type B vs type C), using central randomization with block size 4. Treatment: * Type B thymoma arm: cisplatin 50 mg/m² + doxorubicin 50 mg/m² + cyclophosphamide 500 mg/m², Q3W * Type C thymic carcinoma arm: nab-paclitaxel 200 mg/m² + carboplatin AUC 5, Q3W * Control group: 3 cycles; Experimental group: 6 cycles Imaging assessment (RECIST 1.1) every 2 cycles. CR/PR: proceed to surgery; SD: continue chemotherapy; PD: radical radiotherapy. Post-operative radiotherapy as indicated (R0: 45-50 Gy; R1: 54 Gy; R2: 60-70 Gy). Primary endpoint: Event-Free Survival (EFS), defined as time from randomizatio…
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
Study contacts
- Principal investigator: Fan Jiang, MD, PhD — Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Study coordinator: Fan Jiang, MD, PhD
- Email: fan_jiang@sjtu.edu.cn
- Phone: 86-21-63240090
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.