Thyroid Cancer
Conditions
Interventions
Difficultly differentiated thyroid cancer treated by radioiodine:Famitinib Combined with Camrelizumab
Advanced medullary thyroid carcinoma:Famitinib Combined with Camrelizumab
Advanced undifferentiated thyroid cancer:Famitinib Combined with Camrelizumab
Sponsors
Fudan University Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to qualify for this trial, the patient must meet all of the following admission criteria. 1. The patients volunteered to participate in the study and signed an informed consent form. 2. Age>= 18 years, male and female are not limited; 3. Patients with advanced thyroid cancer who are not cured by local treatments such as surgical or microwave ablation, and the following three types of thyroid cancer are diagnosed by histopathology or cytology (one of which can be satisfied): (1) locally advanced or metastatic differentiated thyroid carcinoma, including papillary thyroid carcinoma (including follicular subtype and poorly differentiated subtype) and thyroid follicular carcinoma (including H ü rthle cell subtype, etc.). (2) locally advanced or metastatic medullary thyroid carcinoma. (3) undifferentiated thyroid carcinoma. 4. If the subject is a patient with differentiated thyroid cancer, the definition of refractory radiation iodine needs to be met (one of the following conditions is met): (1) at least one measurable lesion completely lost its iodine uptake function during iodine radiotherapy; (2) although the lesion had the ability of iodine uptake, at least one of the lesions could be measured, and the disease progression occurred within 12 months after 131I treatment. (3) the cumulative dose of radioiodine therapy was >= 22.2 GBq (>= 600 mCi),) within 6 months before admission. 5. If the subjects were patients with differentiated thyroid cancer, the TSH level should be at the inhibitory level (= 10mm or a short diameter of enlarged lymph nodes >= 15 mm; the lesions that have received local treatment in the past can be used as target lesions according to RECIST vl.1 criteria. 7. ECOG PS:0~2 score; 8. The estimated survival time was >= 12 weeks. 9. The function of the main organs is normal and meets the following requirements (within 7 days before the start of the study): (1) Blood routine examination: (no blood transfusion, no granulocyte colony stimulating factor [G-CSF], no drug correction within 14 days before screening): 1) hemoglobin [HB] >= 90g; 2) absolute neutrophil count [ANC] >= 1.5 x10^9; 3) Platelet [PLT] >= 80 x 10^9; (2) Blood biochemical tests should meet the following criteria (albumin was not infused 14 days before screening): 1) the upper limit of serum total bilirubin [BIL] 50ml/min (Cockcroft-Gault formula). (3) the international standardized ratio [INR] = 2 hours, 24-hour urinary protein can be quantified, and 24-hour urinary protein < 1.0 g can be added to the group). 10. Women of childbearing age must have negative pregnancy tests (serum or urine) within 7 days before entering the group, and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last administration of the study drug. For men, surgical sterilization should be performed, or it should be agreed to use appropriate methods of
Exclusion criteria
Exclusion criteria: Patients will not be allowed to enter this study if they meet any of the following conditions: 1. Suffer from other active malignant tumors within 5 years or at the same time. Cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, etc. 2. Other antineoplastic treatments (including, but not limited to, chemotherapy, radiotherapy) were used in the 28 days prior to the first use of the drug in this study. With the exception of thyrotropin (TSH) inhibition therapy. 3. Patients who have previously been treated with immuno-checkpoint inhibitors (including, but not limited to, Navuleus McAb, Pabolizumab, Teriprim Monoclonal, Cindilimab, etc.). 4. There are clinical symptoms or diseases of the heart that have not been well controlled, such as: (1) according to the (NYHA) standard of the New York Heart Association, cardiac dysfunction above grade II or: LVEF (left ventricular ejection fraction (LVEF) 450ms (male); QTc > 470ms (female) (QTc interval is calculated by Fridericia formula; if QTc is abnormal, it can be detected three times at an interval of 2 minutes). Take the average); 5. Those with hypertension who could not be reduced to the normal range by antihypertensive drugs (systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg) (based on the average of BP readings obtained from >= 2 measurements) were allowed to use antihypertensive therapy to achieve the above parameters. Hypertension crisis or hypertensive encephalopathy occurred in the past. 6. There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 7. Patients at risk of gastrointestinal bleeding were not allowed to enter the group, including the following: (1) patients with active digestive ulcer focus and fecal occult blood (+ +); (2) had a history of black stool and vomiting within 3 months; 8. The patients with abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN),) had bleeding tendency. 9. There was obvious hemoptysis in 2 months before screening, or the amount of hemoptysis reached half teaspoon (2.5ml) or more than half a teaspoon per day. 10. Imaging showed that the tumor had invaded important blood vessels or the researchers judged that the tumor was highly likely to invade important blood vessels during treatment and cause fatal massive bleeding. 11. Thrombosis or embolism occurred within 6 months before the beginning of the study, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism and so on. 12. Current patients with interstitial pneumonia or interstitial lung disease, or with a previous history of interstitial pneumonia or interstitial lung disease requiring hormone treatment, or other pulmonary fibrosis or organized pneumonia that may interfere with the judgment and treatment of immune-associated pulmonary toxicity (e.g., Bronchiolitis obliterans), pneumoconiosis, drug-associated pneumonia, idiopathic pneumonia or subjects with evidence of active p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of Response;Disease Control Rate;Time to response;Progression Free Survival;Overall survival;6-month-overall survival rate;12-month-overall survival rate;adverse event;Abnormal laboratory index value; | — |
Countries
China
Contacts
Public ContactJi Dongmei
Fudan University Cancer Center
Outcome results
None listed