Thymic Epithelial Tumor
Conditions
Interventions
Research Group:neoadjuvant chemotherapy
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with baseline-staged resectable Masaoka stages 3-4 thymic epithelial tumors (ITMIG staging) who are candidates for neoadjuvant chemotherapy; after the first cycle of neoadjuvant chemotherapy, an assessment is made, and if the lesion shrinks, a second cycle of neoadjuvant chemotherapy is administered. (Criteria for neoadjuvant chemotherapy application: patients with no severe adverse reactions to previous chemotherapy, and no clear drug allergies related to chemotherapy medications. Chemotherapy regimens may include gemcitabine plus cisplatin, or nab-paclitaxel plus cisplatin, etc. Gemcitabine: The conventional dose is 1000 mg/m², administered intravenously over approximately 30 minutes. It is usually administered on days 1 and 8. Cisplatin: The conventional dose is 75 mg/m², administered intravenously over approximately 1-2 hours. It is usually given over days 1 and 2. Nab-paclitaxel: The conventional dose is 260 mg/m², administered intravenously over approximately 30 minutes. It is usually given on day 1.) No antineoplastic treatment has been administered for thymic lesions; Age between 18 to 75 years; No contraindications for surgery as assessed by preoperative organ function tests; The following laboratory tests confirm that bone marrow and liver and kidney functions meet the requirements for study participation: Hemoglobin =9.0 g/L; White blood cell count 4.0-10 × 10^9/L; Absolute neutrophil count (ANC) =1.5 × 10^9/L; Platelet count =100 × 10^9/L; Total bilirubin =1.5 times the upper limit of normal (ULN); ALT and AST =2.5 times the ULN; Prothrombin time international normalized ratio (PT INR) =1.5 times the ULN, and partial thromboplastin time within the normal range; Creatinine =1.5 times the ULN; No chemotherapy, radiotherapy, or hormone therapy has been administered for malignant tumors, no history of other malignant tumors, excluding patients with prostate cancer treated with hormone therapy who have achieved more than 5 years of DFS (Disease-Free Survival); Expected to achieve R0 resection; ECOG performance status 0-2; Participants must understand and sign an informed consent form.
Exclusion criteria
Exclusion criteria: Benign thymic tumors; Patients with psychiatric disorders; Patients with existing or concurrent bleeding disorders; Patients with other uncontrollable, inoperable conditions; Patients for whom previous surgery has rendered this surgery unfeasible; Female patients who are pregnant or breastfeeding; Patients allergic to the medications included in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| EFS;MPR;R0 resection rate;safety; | — |
Countries
China
Contacts
Public ContactFan Jiang
Shanghai General Hospital
Outcome results
None listed