Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors (NCT03827837) | Clinical Trial Compass
UnknownPhase 2
Famitinib Plus Anti-PD1 Therapy for Advanced Urinary System Tumor, Advanced Gynecological Tumors
China265 participantsStarted 2019-01-23
Plain-language summary
Phase II multi-chort, adaptive two-stage, open label, nonrandomized study. The aim of our study is to evaluate the efficacy and safety of anti-PD-1 antibody SHR-1210(Camrelizumab) in combination with a small-molecule multikinase inhibitor Famitinib in subjects with advanced RCC/UC/CC/EC and recurrent OC.
chort1: Renal Cell Carcinoma (RCC) chort2: Urothelial Carcinoma(UC) chort3: Ovarian Cancer (OC) chort4: Cervical Cancer (CC) chort5: Endometrial Cancer (EC)
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
ā. Be willing and able to provide written informed consent/ for the trial.
ā. Be at least 18 years of age on day of signing informed consent, male or female.
ā. Patients with one of the following tumors:
ā. At least one measurable lesion according to RECIST 1.1.
ā. The patients can swallow pills.
ā. Eastern Cooperative Oncology Group (ECOG) performance status of ā¤ 1.
ā. Life expectancy of at least 12 weeks.
ā. The results of patients' blood tests are as follows:-Neutrophilsā„1.5E+9/L; - Pltā„90E+9/L; -Hbā„90g/L; -ALBā„30g/L ;-TSHā¤1ĆULN;-TBIL ā¤ 1 ĆULN;-ALT and AST ā¤ 3 ĆULN; AKPā¤ 2.5ĆULN; -Creatinine ā¤ 1.5ĆULN.
Exclusion criteria
ā. Patients with any active autoimmune disease or history of autoimmune disease, including but not limited to the following: hepatitis, pneumonitis, uveitis, colitis (inflammatory bowel disease), hypophysitis, vasculitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Asthma that requires intermittent use of bronchodilators or other medical intervention should also be excluded.
ā. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids. Doses \> 10 mg/day prednisone or equivalent are prohibited within 2 weeks before study drug administration.
. Known history of hypersensitivity to other antibody formulation.
ā. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 2 weeks prior to trial treatment.
ā. Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents: systolic blood pressure ā„140 mmHg, diastolic blood pressure ā„ 90 mmHg.
ā. Clinically significant cardiovascular and cerebrovascular diseases, including but not limited toļ¼1ļ¼Congestive heart failure (New York heart association (NYHA) class \> 2)ļ¼ļ¼2ļ¼unstable or severe angina; ļ¼3ļ¼myocardial infarction within 12 months before enrollmentļ¼ļ¼4ļ¼ ventricular arrhythmia which need medical intervention.ļ¼5ļ¼QTc\>450msļ¼maleļ¼/QTc\>470ms (female)ļ¼
ā. Coagulation abnormalities (INR\>2.0ćPT\>16s), with bleeding tendency or are receiving thrombolytic or anticoagulant therapy.
ā. Bleeding history, having bleeding eventļ¼ā„3 Grade according CTCAE 4.0 ļ¼within 4 weeks before screening.