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

NCT07463313 | Not Yet Recruiting Phase 2 DMC

• 2 other identifiers: 202511091019224382026HS060
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thymoma and Thymic Carcinoma

Keywords

Neoadjuvant Chemotherapy; Thymic Epithelial Tumor; Thymic Carcinoma; Event-Free Survival; Mediastinal Tumor

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years from randomization

Secondary Outcomes (6)

• Objective Response Rate (ORR)

  After completion of neoadjuvant chemotherapy (approximately 9 weeks for 3-cycle arm; approximately 18 weeks for 6-cycle arm)

• 3-Year Event-Free Survival Rate

  3 years from randomization

• R0 Resection Rate

  At the time of surgery

• Pathological Complete Response (pCR) Rate

  At the time of surgery

• Major Pathological Response (MPR) Rate

  At the time of surgery

Study Arms (2)

6-Cycle Neoadjuvant Chemotherapy

EXPERIMENTAL

Participants receive 6 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg/m2 IV + doxorubicin 50 mg/m2 IV + cisplatin 50 mg/m2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg/m2 IV + carboplatin AUC 5 IV, every 3 weeks.

Drug: Cyclophosphamide, Doxorubicin, and Cisplatin (CAP); Drug: nab-Paclitaxel and Carboplatin

3-Cycle Neoadjuvant Chemotherapy

ACTIVE COMPARATOR

Participants receive 3 cycles of neoadjuvant chemotherapy prior to surgery. For WHO type B thymoma: cyclophosphamide 500 mg/m2 IV + doxorubicin 50 mg/m2 IV + cisplatin 50 mg/m2 IV (CAP regimen), every 3 weeks. For thymic carcinoma: nab-paclitaxel 260 mg/m2 IV + carboplatin AUC 5 IV, every 3 weeks.

Drug: Cyclophosphamide, Doxorubicin, and Cisplatin (CAP); Drug: nab-Paclitaxel and Carboplatin

Interventions

Cyclophosphamide, Doxorubicin, and Cisplatin (CAP) DRUG

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.

3-Cycle Neoadjuvant Chemotherapy; 6-Cycle Neoadjuvant Chemotherapy

nab-Paclitaxel and Carboplatin DRUG

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.

3-Cycle Neoadjuvant Chemotherapy; 6-Cycle Neoadjuvant Chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Thymoma; Thymic epithelial tumor; Mediastinal Neoplasms

Interventions

Cyclophosphamide; Doxorubicin; Cisplatin; 130-nm albumin-bound paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Thymus Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lymphatic Diseases; Hemic and Lymphatic Diseases; Mediastinal Diseases; Thoracic Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes

Study Officials

• Fan Jiang, MD, PhD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fan Jiang, MD, PhD

CONTACT

86-21-63240090; fan_jiang@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Surgery

Study Record Dates

• First Submitted: March 6, 2026
• First Posted: March 11, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2032
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)