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Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma | Clinical Trials | Clareo Health

UNKNOWNPHASE2

Anlotinib Plus Sintilimab as First-line Treatment for Advanced Non Clear Cell Renal Cell Carcinoma

NCT05220267•Sun Yat-sen University

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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).
+7 more criteria

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;
+6 more criteria

Locations (1)

Cancer Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Key Dates

Start Date

February 28, 2022

Primary Completion Date

December 30, 2024

Completion Date

December 30, 2024

Last Updated

February 2, 2022

Enrollment

ESTIMATED participants

Conditions

Non Clear Cell Renal Carcinoma

Interventions

Anlotinib plus Sintilimab

DRUG