Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma
Carcinoma, Renal Cell, Fumarate Hydratase Deficiency, Immunotherapy
About this trial
This is an interventional treatment trial for Carcinoma, Renal Cell focused on measuring Sintilimab, Inlyta
Eligibility Criteria
Inclusion Criteria:
- age ≥ 18;
- histology characteristics accord with FH-deficient RCC;
- gene testing confirms germline and/or somatic FH gene mutation ;
- ECOG (Eastern Cooperative Oncology Group)≤2;
- expected survival >3 months;
- blood routine indexes: neutrophils ≥1.5*109, platelets ≥100*109, hemoglobin ≥90g/L;
- liver function: bilirubin ≤ normal upper limit 1.5 times, AST≤ normal upper limit 2.5 times;Serum creatinine ≤ 1.5 times of normal upper limit;Serum calcium concentration: ≤12.0 mg/dL;
- coagulation function: PT≤ 1.5 times of normal upper limit;
- the following diseases did not appear within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.
- all patients signed informed consent.
Exclusion Criteria:
- other malignancies previously or at the same time that are different from the primary site or histology of the tumor assessed in this study, except cervical carcinoma in situ, basal-cell carcinoma that has been fully treated, superficial bladder tumor (Ta, Tis, T1) or other malignancies that occurred before the enrollment and have been cured for more than 3 years;
- renal decompensation requires hemodialysis or peritoneal dialysis;
- arrhythmia need anti-arrhythmic treatment, symptomatic coronary artery disease or myocardial ischemia (myocardial infarction), nearly six months, or congestive heart failure than NYHA Ⅱ level; Hypertension (systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg) that has been treated with 2 or more antihypertensive treatments and still cannot be controlled;
- severe active clinical infection;
- patients with coagulation disorder or bleeding constitution;
- major surgery or severe trauma was performed within 4 weeks before enrollment;
- a history of allogeneic organ transplantation or bone marrow transplantation;
- drug abuse and medical, psychological or social conditions that may interfere with patients' participation in research or affect the evaluation of results;
- known or suspected allergy to the study drug;
- those who received treatment other than this study within 4 weeks prior to and during the study period.
Sites / Locations
- West China HospitalRecruiting
Arms of the Study
Arm 1
Experimental
Sintilimab injection combined with Inlyta
Sintilimab injection 10ml: 100mg, 200mg intravenously, once every three weeks. Course of treatment: discontinue medication when the disease progresses clinically or radiologically. Inlyta 5mg orally, twice a day. Course of treatment: continue treatment as long as a clinical benefit is observed, or until an unacceptable toxicity is present that cannot be controlled by combination or dose adjustment. In the whole research process, if the disease progresses, the attending doctor has the right to carefully choose other anti-tumor methods, including radiotherapy, chemotherapy and other targeted drugs.