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

Sun Yat-sen University1 site in 1 country43 target enrollmentFebruary 28, 2022

ConditionsNon Clear Cell Renal Carcinoma

InterventionsAnlotinib plus Sintilimab

DrugsAnlotinib plus Sintilimab

Overview

Phase: Phase 2
Intervention: Anlotinib plus Sintilimab
Conditions: Non Clear Cell Renal Carcinoma
Sponsor: Sun Yat-sen University
Enrollment: 43
Locations: 1
Primary Endpoint: progression-free survival (PFS)
Status: Not yet recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 28, 2022

End Date

December 30, 2024

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

ZHOU FANGJIAN

Director

Sun Yat-sen University

Eligibility Criteria

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:
•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).

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;

Arms & Interventions

Anlotinib plus Sintilimab

Anlotinib was taken orally (10mg mg qd, d1-14, 21 days per cycle) .Sintilimab was administered intravenously (200mg once every 3weeks).

Intervention: Anlotinib plus Sintilimab

Outcomes

Primary Outcomes

progression-free survival (PFS)

Time Frame: up to 2 years

Time from treatment until disease progression or death

Secondary Outcomes

objective response rate (ORR)(up to 2 years)
disease control rate (DCR)(up to 2 years)
overall survival (OS)(up to 2 years)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(up to 2 years)