Status:
UNKNOWN
Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma
Lead Sponsor:
Sun Yat-sen University
Conditions:
Non Clear Cell Renal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 effic...
Eligibility Criteria
Inclusion
- 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:
- Absolute neutrophil count (ANC) ≥1.5x 109/L
- Lymphocyte count ≥ 500/uL.
- Platelet count ≥ 80x109/L.
- Hemoglobin ≥ 80 g/L (patients may be transfused to meet this criterion).
- 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.
- Serum bilirubin ≤ 1.5 x ULN.
- Creatinine clearance ≥ 60 mL/min.
- 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
- 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.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2024
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT05220267
Start Date
February 28 2022
End Date
December 30 2024
Last Update
February 2 2022
Active Locations (1)
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1
Cancer Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060