A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

Phase 3Active Not RecruitingNCT04523272

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.528 enrolled

Overview

This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus sunitinib in subjects with advanced renal cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

528

Conditions

Advanced Renal Cancer

Interventions

TQB2450DRUG

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

AnlotinibDRUG

A multi-target receptor tyrosine kinase inhibitor.

SunitinibDRUG

A multi-target receptor tyrosine kinase inhibitor.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 1\. Histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components. 2\. Has not receiving systemic therapy for local advanced/metastatic disease. 3. At least has one measurable lesion. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 5\. Adequate laboratory indicators. 6. Agree to provide at least 5 slices tumor tissue samples for biomarker detection. 7\. Serum or urine pregnancy tests are negative within 7 days before randomization; Men and women should agree to use effective contraception during the study period and after the end of the study period within 6 months. 8\. Understood and signed an informed consent form. Exclusion Criteria: * 1\. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease. 2\. Has received anti-angiogenesis targeted therapy or targeted PD-1 and PD-L1 immunotherapy. 3\. Has active virus, bacteria, fungal infection; Cardiovascular and cerebrovascular diseases; Gastrointestinal abnormalities; Immunodeficiency; Bleeding risk; Lung disease; Neurological or psychiatric disorders. 4\. Has participated in other clinical trials within 30 days before randomization. 5\. Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period. 6\. Pregnant or lactating women. 7. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Locations (39)

Outcomes

Primary Outcomes

Progression free survival (PFS) evaluated by Independent Review Committee(IRC)

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.

Time frame: up to 60 weeks

Secondary Outcomes

Progression free survival (PFS) evaluated by investigator

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.

Time frame: up to 60 weeks

Overall survival (OS)

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

Time frame: up to 60 weeks

Disease control rate（DCR）

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

Time frame: up to 60 weeks

Duration of response（DOR）

The time when the participants first achieved complete or partial remission to disease progression.

Time frame: up to 60 weeks

Progression-free survival at 12 months

Percentage of participants whose PFS has achieved at least 12 months.

Time frame: up to 12 months

Overall survival at 12 months

Percentage of participants whose OS has achieved at least 12 months.

Data from ClinicalTrials.gov

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The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences