Poorly differentiated and undifferentiated carcinoma of the thyroid
Conditions
Interventions
experimental group:carilizumab combined with apatinib
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Participate voluntarily and sign an informed consent in writing. 2. Age: 18 ~ 75 years old, male or female. 3. Poorly differentiated or undifferentiated thyroid carcinoma confirmed by histology or cytology. 4. Patients who have received previous surgery, I131 treatment, radiotherapy, and chemotherapy can be enrolled. 5. According to the RECIST 1.1 standard, at least one measurable target lesion exists, the measurable lesion defines a single tumor diameter, LAD (longest diameter) >= 10mm; lymph node SAD (shortest diameter) >= 15mm; the largest tumor diameter is measured by conventional methods >= 20mm; Spiral CT measurement >= 10mm; measurable lesions should not have received local treatment such as radiotherapy; (target lesions located in the previous radiotherapy area, if it is confirmed that progress has occurred and meets RECIST1.1 standards, it can also be selected as a target lesion). 6. General physical condition (Karnofsky score) >= 70 points. 7. Blood routine: absolute neutrophil count (ANC) >= 1.5 * 10^9 / L (1500 / mm3); platelet >= 100 * 10^9 / L (100,000 / mm3); hemoglobin >= 9 g / dL (90g / L) . 8. Liver function: total serum bilirubin (BIL) = 50% during cardiac function test. 11. No serious complications such as active gastrointestinal bleeding, perforation, jaundice, gastrointestinal obstruction, non-cancerous fever> 38 degrees C. 12. It is expected that those with good compliance can follow up the curative effect and adverse reactions according to the requirements of the plan.
Exclusion criteria
Exclusion criteria: 1. Severe active infections, serious infections (CTC AE greater than 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, infection comorbidities that require hospitalization; baseline chest imaging Prompt the existence of active lung inflammation, the symptoms and signs of infection within 2 weeks before the first use of the study drug or the need for oral or intravenous antibiotic treatment, except for the prophylactic antibiotic use; 2. A history of gastrointestinal perforation and / or fistula within 6 months before the first medication; 3. There is uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage; 4. Patients who have active tuberculosis infection through medical history or CT examination, or have a history of active tuberculosis infection within 1 year before enrollment, or patients who have a history of active tuberculosis infection more than 1 year ago but have not been formally treated; 5. Any other malignant tumor was diagnosed within 3 years before the first use of the study drug, except for malignant tumors with low risk of metastasis and risk of death (5-year survival rate> 90%), such as fully treated basal cell or squamous cell skin Except for cancer or carcinoma in situ of the cervix; 6. Past or present patients with heart disease grade 2 or above according to the New York Heart Association; 7. Patients with a clear bleeding tendency, including: those with locally active ulcer lesions, and stool occult blood (++) cannot be included in the group, and those with a history of black stools and hematemesis within 2 months; 8. Imaging shows that the tumor has invaded important blood vessels or the researcher judges that the patient has a very high possibility of invading important blood vessels during tumor treatment, causing fatal hemorrhage; 9. Patients with central nervous system disease or symptomatic central nervous system metastasis. 10. Patients with previous contraindications for immunotherapy (patients with immunodeficiency disease). For example, a history of basic diseases of the immune system, including some active infections, patients with poor liver and kidney function or heart function at baseline; 11. Patients who are known to be allergic, highly sensitive or intolerable to study-related drugs or their accessories; 12. Receive other immune-related drugs within 30 days after the first immunotherapy; 13. Women who are pregnant or breastfeeding; 14. According to the investigator's judgment, the subject has other factors that may cause him to be forced to terminate the study halfway, such as having other serious diseases (including mental illness) that require combined treatment, laboratory examination values ??are abnormally abnormal, family or social factors, The situation that may affect the collection of test data of the subjects; 15. Researchers think it is not suitable for inclusion;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| DCR;PFS;OS;Quality of life assessment;Relationship between PD-L1 expression, BRAF gene and efficacy;Adverse events; | — |
Countries
China
Contacts
Public ContactFang Meiyu
Zhejiang Cancer Hospital
Outcome results
None listed