thymic carcinoma
Conditions
Interventions
Experimental Group:Neoadjuvant: Adalimumab + Albumin Paclitaxel + Carboplatin, quaque 3 weeks, 2-3 cycles ? Surgery ? Adjuvant: Adalimumab + Albumin Paclitaxel + Carboplatin, quaque 3 weeks, 2-3 cycle
Sponsors
Nanjing Drum Tower hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed resectable locally advanced (defined by the Masaoka-Koga classification as stage II-IVa) disease, aged 18 years or older; 2. Clinical stage Il-IVA (TNM staging system), non-myasthenia gravis (MG) patients, expected to be operable; 3. No previous treatment with any anti-thymic tumor therapy, including but not limited to systemic chemotherapy, radiotherapy or immunotherapy, etc.; 4. At least one measurable lesion (according to the Response Evaluation Criteria in Solid Tumors RECIST V1.1); 5. No asymptomatic brain metastases, no cancerous meningitis or spinal metastases requiring radiotherapy or surgery; 6. No patients with pericardial effusion, pleural effusion or ascites that require treatment.
Exclusion criteria
Exclusion criteria: 1. Pathologically diagnosed as thymic neuroendocrine tumor; 2. Had previously or currently suffered from interstitial pneumonia/lung disease requiring systemic hormone therapy; 3. Had multiple primary malignant tumors within 5 years; 4. Interstitial lung disease; 5. Had thrombosis or heart events within 6 months prior to clinical trial registration; 6. Proteinuria greater than or equal to 1 gram per 24 hours; 7. Infection requiring systemic treatment, fever of 38 degrees Celsius or above, active hemoptysis (within 21 days prior to registration); 8. Patients with positive HIV antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main pathological remission rate;Clinical downstaging rate (downstaging of T and/or N);Event-free survival period; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate;R0 resection rate;Disease control rate;Pathological complete response rate;Overall survival period; | — |
Countries
China
Contacts
Public ContactYang yang/Xie Jiaqi
Nanjing Drum Tower hospital
Outcome results
None listed