Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT05816694
Eligibility Criteria:
Inclusion Criteria:
* 18-75 years；
* Histological or cytological confirmed stage Ⅲ and Ⅳa thymoma;
* PET/CT or CT/MRI with at least one objectively measurable or evaluable lesion；
* Life expectancy \>12months；
* ECOG PS 0-1；
--Patients with thymoma metastasis；
* No found the other malignant tumors (expect has been controlled Carcinoma in situ of the cervix and Basal Cell Carcinoma）；
* Informed consent was signed before the study began；
* Normal Bone marrow hematopoiesis and renal function，Blood routine: absolute neutrophil count≥1,500/uL，Hb\>8.0g/dL，PLT\>80×10\*9/L，AST≤ 1.5 times the upper limit of normal，TBIL ≤1.5 times the upper limit of normal，calculated creatinine clearance ≤110µmol/L，blood urea nitrogen≤7.1mmol/L；
* Cardiac function: LVEF≥55%；
* Patients who have not active bleeding or coagulopathy before enrollment；
Exclusion Criteria:
* -Patients who have been found thymoma metastasis；
* Patients with uncontrolled lung disease, Serious infection,active peptic ulcers, coagulation diaorders, Uncontrolled severe diabetes, connective tissue diseases or Bone marrow suppression and Induction therapy for intolerance；
* Peripheral neuropathy ≥ Grade 2 (NCI-CTCAE version 5.0 )；
* Significant organ dysfunction: such as respiratory failure, NYHA classification Class III or IV, chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure（SBP\> 180 mmHg or DBP\> 100mmHg）；
* Pregnant and lactating women；
* patients without undergo preoperative puncture biopsy or induction therapy；
* Patients with active uncontrollable neurological, mental disease or mental disorder, poor compliance, unable to cooperate and describe the treatment response；
* Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study；
* Known HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded；
* Patients with uncontrollable Stable myasthenia gravis or uncontrollable Serious autoimmune disease such as fulminant DIC；
* Patients who are known to be allergic or intolerant to chemotherapy drugs；
* severe-trauma；
* Patients who have received any other investigational drug treatment or participated in any other clinical trials within 30 days prior to enrollment in this study；
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05816694
Study Brief:
Protocol Section:
NCT05816694