Thymic carcinoma
Conditions
Interventions
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with thymic carcinoma confirmed by tissue or cytological diagnosis 2) Correspond to any of the following a. Unresectable Masaoka-Koga classification IIIa or IIIb thymic carcinoma b. Masaoka-Koga classification IVa or IVb thymic carcinoma c. Recurrent thymic carcinoma 3) Patients who had received at least one previous platinum-based chemo (radio) therapy 4) No symptomatic brain metastasis, carcinomatous meningitis, vertebral metastasis requiring radiotherapy or surgery 5) No cardiac effusion, pleural effusion and ascites requiring any treatment 6) Aged 20 or above at the time of registration 7) Performance Status 0 or 1 8) Oral intake 9) One or more measurable lesions confirmed by contrast enhanced CT 10) No prior treatment of agents targeting the VEGFR 11) Not received anti-cancer therapy within 14days before registration 12) Not having any of the following histories/complications a.History of hypertensive crisis or hypertensive encephalopathy b. History of surgery under general anesthesia within 28days before registration c. History of total gastrectomy d.Unrecovered wound, active gastrointestinal ulcer e.Congenital hemorrhagic diathesis or coagulation disorder 13)Adequately controlled blood pressure 14)Patients in laboratory tests performed within 14 days before registration 15) Patients who achieved an SpO2 of 92% or more under room air conditions within 14 days before registration 16) Given consent to contraception 17) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Active double cancer; synchronous or metachronous within 5years. Patients with carcinoma in situ are eligible 2) Infections requiring systemic therapy 3) Fever of >=38 degrees Celsius at the time of registration 4) Active hemoptysis (more than half a teaspoon of blood) within 21days before registration 5) Interstitial pneumonia and/or pulmonary fibrosis diagnosed by chest CT imaging or clinical examinations 6) Grade >=2 adverse reactions caused by prior therapy except any grade of alopecia 7) History of any of the followings; unstable angina within 6 months before registration, heart attack, pulmonary embolism, deep vein thrombosis, brain bleeding, cerebral infarction, transient ischemic attacks within 6 months before registration and arterial thromboembolism 8) HIV antibody positive 9) Pregnant or breast-feeding women, or women suspected of being pregnant 10) Mental disease interfering taking part in the trial 11) Taking continuous systemic steroids and/or other immunosuppressive drugs (orally or intravenously)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate; Central Review | — |
Secondary
| Measure | Time frame |
|---|---|
| 1)Response rate; assessed by the investigator 2)Progression Free Survival (PFS) 3)Overall Survival (OS) 4)Clinical Benefit Response (CBR) 5)Adverse Event | — |
Countries
Japan
Contacts
Public ContactHitoshi Ozawa
National Cancer Center Hospital Clinical Trial Support Office
Outcome results
None listed