Undifferentiated thyroid carcinoma
Conditions
Interventions
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >18years old, both genders; 2. Histologically or cytologically confirmed locally advanced or metastatic thyroid undifferentiated thyroid cancer (unresectable thyroid undifferentiated thyroid cancer?in the stage IVA, IVB and IVC, recurrence after radical resection, disease progression after systemic chemotherapy or radiotherapy, patients who can not tolerate chemotherapy or are not able to receive chemotherapy. At least one measurable lesion as defined by RECIST 1.1; 3. Chemotherapy intolerance: With more than grade 4 on hematologic toxicity or over grade 3 on non-hematologic toxicity or major organ damage including the heart and liver and kidney above grade 2 during the treatment process 4. The study enrolled patients from previous treatment failure (informed consent time) over 2 weeks; accept the other treatment damage which have been restored, the interval of accepting the nitroso or mitomycin over 6 weeks to ; accept other cytotoxic drugs, radiotherapy or surgery over 4 weeks, and the wound healing has been completed; 5. Karnofsky point >70; 6. Life expectancy of more than 12 weeks; 7. The main organ function meeting the following: (1)blood routine examination meeting the standards: HB = 90 g/L; ANC = 1.5×10^9/L; PLT = 60×10^9/L; (2)blood biochemical examination: ALB >29g/L; ALT, AST = 2.5 × ULN, if the liver metastasis = 5 × ULN, TBIL <1.5 times the upper limit of normal (ULN); SCr (serum creatinine) <1.5 times the upper limit of normal (ULN); 8. Pregnancy test (serum or urine) has to be performed for woman of childbearing age within 7 days before enrolment and the test result must be negative. They shall take appropriate methods for contraception during the study and 8 weeks after the last administration of study drug. For men, shall accept surgical sterilization or agree to take appropriate methods of contraception during the study and 8 weeks after the last administration of study drug; 9. participants volunteered to participate in this study, signed informed consent, compliance, with follow-up.
Exclusion criteria
Exclusion criteria: 1. Before(within 5years) or at the same time any, there were other untreated malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix; 2. Pregnant or lactating women; 3. Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), with grade I coronary heart disease, grade I arrhythmia (including QTc interval male = 450 ms, female =470 ms) and grade I cardiac insufficiency; patients with positive urine protei; 4. There are several factors that affect oral medicine, such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction; 5. Patients with a clear tendency of gastrointestinal bleeding can not be allowed tp into the group, including the following: local active ulceration, fecal, occult blood test(++), The history of hematemesis and melena within 2 months; 6. Patients with central nervous system metastases; 7. Coagulation disorders(INR>1.5APTT>1.5 ULN).patients with bleeding tendency; 8. Patients with a history of psychiatric drug abuse and can not be prevented or have mental disorders; 9. Participated in other drug clinical trials within four weeks; 10. Patients with clinical symptoms that require clinical treatment for the intervention of hydrothorax, ascites, or pericardial effusion; 11. Received VEGFR inhibitor, such as sorafenib sunitinib; 12. According to the researcher's judgment, there is a serious risk of compromising the patient's safety or affecting the patient's completion of the study; 13. Patients with objective evidence of past and present pulmonary fibrosis history, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug associated pneumonia, and severe lung function impairment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| QoL;OS;TTP;Safety and Toxicity; | — |
Countries
China
Contacts
Public ContactMinghua Ge
Zhejiang Cancer Hospital
Outcome results
None listed