Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Other: Anlotinib plus Sintilimab Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle) .Sintilimab was administered intravenously (200mg once every 3weeks). |
Drug: Anlotinib plus Sintilimab
Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle).Sintilimab was administered intravenously (200mg once every 3weeks).
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Outcome Measures
Primary Outcome Measures
- progression-free survival (PFS) [up to 2 years]
Time from treatment until disease progression or death
Secondary Outcome Measures
- objective response rate (ORR) [up to 2 years]
objective response rate (ORR) by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR)
- disease control rate (DCR) [up to 2 years]
disease control rate (DCR)by RECIST1.1, the total proportion of patients with complete response (CR), partial response (PR) and Stable Disease(SD).
- overall survival (OS) [up to 2 years]
Time from treatment until death from any cause
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [up to 2 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects voluntarily joined the study and signed informed consent;
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Aged > 18 years;
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ECOG body status score is 0 or 1,Expected survival time is greater than 3 months.
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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.
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Patients must have measurable lesions as defined by the RECIST 1.1 standard;
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Adequate hematologic and end-organ function as defined by the following laboratory results obtained within 28 days prior to the first study treatment:
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Absolute neutrophil count (ANC) ≥1.5x 109/L
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Lymphocyte count ≥ 500/uL.
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Platelet count ≥ 80x109/L.
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Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion).
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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.
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Serum bilirubin ≤ 1.5 x ULN.
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Creatinine clearance ≥ 60 mL/min.
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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.
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Signed informed consent form.
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Ability and capacity to comply with study and follow-up procedures.
Exclusion Criteria:
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Those who are known to be allergic to pharmaceutical ingredients.
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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;
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Previous use of anlotinib or other angiogenesis inhibitors
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The patient has any active autoimmune disease or a history of autoimmune disease;
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There are uncontrolled heart clinical symptoms or diseases;
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Patients with congenital or acquired immune deficiency;
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Receive chemotherapy, targeted therapy, radiotherapy within 2 weeks before enrollment;
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A history of gastrointestinal perforation or major surgery within 4 weeks before enrollment;
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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;
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Those with active bleeding or bleeding tendency;
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Presence of a drug uncontrolled hypertension;
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Urine routine indicates more than urinary protein 2+;
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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;
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Patients suspected of having other primary cancers;
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Those who are known to be allergic to pharmaceutical ingredients.
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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.
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Active hepatitis C infection. Patients positive hepatitis C antibody test are eligible if PCR is negative for hepatitis C viral DNA.
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Pregnant or lactating women.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cancer Center, Sun Yat-sen University | Guangzhou | Guangdong | China | 510060 |
Sponsors and Collaborators
- Sun Yat-sen University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- SL-B2021-245-02