Non Clear Cell Renal Carcinoma Clinical Trial
Official title:
Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma
Verified date | January 2022 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The combination of immune checkpoint inhibitors (ICIs) plus angiogenesis inhibitors has demonstrated significant anti-tumor activity in certain cancer. The goal of this study was to evaluate the efficacy and safety of sintilimab (a human programmed death-1 ICI) plus anlotinib (a multi-target tyrosine kinase inhibitor, inhibiting tumor angiogenesis and proliferative signaling) in advanced non clear cell renal cell carcinoma.
Status | Not yet recruiting |
Enrollment | 43 |
Est. completion date | December 30, 2024 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects voluntarily joined the study and signed informed consent; - Aged > 18 years; - ECOG body status score is 0 or 1,Expected survival time is greater than 3 months. - Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified. - Patients must have measurable lesions as defined by the RECIST 1.1 standard; - Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment: 1. Absolute neutrophil count (ANC) =1.5x 109/L 2. Lymphocyte count = 500/uL. 3. Platelet count = 80x109/L. 4. Hemoglobin = 80 g/L (patients may be transfused to meet this criterion). 5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 x upper limit of normal (ULN) with the following exceptions: Patients with documented liver/bone metastases should have AST and ALT = 5 x ULN. 6. Serum bilirubin = 1.5 x ULN. 7. Creatinine clearance = 60 mL/min. 8. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use highly effective forms of contraception and to continue its use 4 weeks after the last dose of anlotinib or sintilimab. - Signed informed consent form. - Ability and capacity to comply with study and follow-up procedures. Exclusion Criteria: - Those who are known to be allergic to pharmaceutical ingredients. - Receive anti-tumor monoclonal antibody or other research drugs within 4 weeks before enrollment; have received other anti-PD-1 antibody therapy or other treatment for PD-1/PD-L1; - Previous use of anlotinib or other angiogenesis inhibitors - The patient has any active autoimmune disease or a history of autoimmune disease; - There are uncontrolled heart clinical symptoms or diseases; - Patients with congenital or acquired immune deficiency; - Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment; - A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment; - Overactive/venous thrombosis occurred within 6 months prior to enrollment, such as cardiovascular-cerebral vascular (including transient ischemic attack),deep vein thrombosis (except for patients who have recovered from venous catheterization due to previous chemotherapy)and pulmonary embolism; - Those with active bleeding or bleeding tendency; - Presence of a drug uncontrolled hypertension; - Urine routine indicates more than urinary protein 2+; - Correct QT interval > 470msec; if the patient has a prolonged QT interval, but the investigator's study evaluates that the prolongation is due to a cardiac pacemaker (and no other abnormalities in the heart), it is necessary to discuss with the sponsor's researcher to determine if the patient is Suitable for group study; - Patients suspected of having other primary cancers; - Those who are known to be allergic to pharmaceutical ingredients. - Patients with active or chronic hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening). Patients with past/resolved HBV infection (defined as having negative HBsAg test and a positive antibody to hepatitis B core antigen [anti-HBc] antibody test) are eligible. A negative HBA DNA test must be obtained in patients with positive hepatitis B core antibody prior to Cycle 1 Day 1. - Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA. - Pregnant or lactating women. |
Country | Name | City | State |
---|---|---|---|
China | Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progression-free survival (PFS) | Time from treatment until disease progression or death | up to 2 years | |
Secondary | objective response rate (ORR) | objective response rate (ORR) by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) | up to 2 years | |
Secondary | disease control rate (DCR) | disease control rate (DCR)by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) and Stable Disease(SD). | up to 2 years | |
Secondary | overall survival (OS) | Time from treatment until death from any cause | up to 2 years | |
Secondary | Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | up to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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