Sintilimab Injection Combined With Inlyta in Fumarate Hydratase- Deficient Renal Cell Carcinoma

  • End date
    Dec 1, 2023
  • participants needed
  • sponsor
    West China Hospital
Updated on 21 July 2021


This is a single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in fumarate hydratase-deficient renal cell carcinoma.


Our previous genetic research as well as other published data indicated the possible well response to combination of immunotherapy with targeted therapy in FH-deficient renal cell carcinoma, therefore the investigators intented to perform this single-arm phase II clinical trial to evaluate the initial efficacy and safety of Sintilimab injection combined with Inlyta in FH-deficient renal cell carcinoma.

Condition Renal Cell Carcinoma, Immunotherapy, immunotherapies, Fumarate Hydratase Deficiency
Treatment Sintilimab injection plus Inlyta treatment
Clinical Study IdentifierNCT04387500
SponsorWest China Hospital
Last Modified on21 July 2021


Yes No Not Sure

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 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
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