thyroid carcinoma
Conditions
Interventions
experimental group:omega-3
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. First diagnosed thyroid cancer (all differentiated pathological subtypes), with or without BRAF gene mutation, TERT promoter mutation and other gene mutations, without thyroiditis; 2. After thyroidectomy pending standard 131I ablation and has not received other systematic anti-tumor treatment; 3. Age >= 18 years old and = 3.0 x 10^9/L, absolute neutrophil count >= 1.5x 10^9/L, platelet count >= 100 x 10^9/L, hemoglobin >= 90g/L (no blood transfusion within 14 days); 2) Biochemical examinations must meet the following criteria: BIL = 60ml/min; good coagulation function, INR and PT <= 1.5 times ULN; 6. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; the serum or urine pregnancy test is negative within 7 days prior to study enrollment, and Must be a non-lactating patient. The males should agree to use contraception during the study period and within 6 months of the end of the study period; 7. Patients voluntarily joined the study and signed informed consent, and compliance was good.
Exclusion criteria
Exclusion criteria: 1. Dedifferentiated thyroid cancer and medullary thyroid cancer; 2. Previously received any systematic anti-tumor treatment, including radiotherapy, chemotherapy, immunotherapy and Chinese medicine treatment; 3. Having digestive disorder history with a variety of factors affecting oral medication (such as inability to swallow, postoperative gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc.); 4. Patients with any severe and/or uncontrolled diseases, such as: 1) Unstable myocardial ischemia, symptomatic congestive heart failure, myocardial infarction within 6 months prior to randomization, severe uncontrolled arrhythmia; 2) Unsatisfactory blood pressure control (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg) patients; 3) Active or uncontrolled serious infection; 4) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 5) Poor control of diabetes (fasting blood glucose (FBG) > 10mmol / L); 6) Urine routine indicates urinary protein >= ++, and 24-hour urine protein quantitation > 1.0 g; 7) Active tuberculosis; 8)Uncontrolled hypercalcemia (serum calcium >= 2.75 mmol / L) or the need for continued bisphosphonate treatment symptomatic Calcemia; 9) A long-term unhealed wound or fracture, etc. 5. Those who have a history of psychotropic substance abuse and are unable to quit or have mental disorders; 6. Participated in other clinical trials of anti-tumor drugs within four weeks; previously received immunotherapy, such as anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or against another stimulus or synergistic inhibition of T cell receptors (For example, drugs of CTLA-4, OX-40, CD137); 7. A history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation; 8. Allergic history to iodine; 9. Immunosuppressive drugs were used within 4 weeks prior to enrollment, but did not include nasal glucocorticoids or other routes of topical glucocorticoids or physiological doses of systemic glucocorticoids, i.e. no more than 10 mg/day of prednisone or equivalent dose of other glucocorticoids; 10. known or suspected active autoimmune diseases (congenital or acquired), such as interstitial pneumonia, uveitis, enteritis, hepatitis, pituititis, vasculitis, nephritis, thyroiditis (autoimmune thyroiditis confirmed before thyroidectomy, or preoperative serum APOAb > 34 IU/ml or TRAb > 34 IU/ml), etc.; 11. Allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 12. According to the investigator's judgment, exclude the subjects with factors harassing the completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Karnofsky score;Blood routine, liver function and renal function ;Salivary gland secretory function index;Serum CD44V6, sIL-2R and VEGF expression levels;Stool abundance and diversity ; | — |
Countries
China
Contacts
Public ContactLi Dan
Shanghai Tenth People's Hospital
Outcome results
None listed