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A Study of TQB2450 Injection ...

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

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Renal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TQB2450 + Anlotinib

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Group Type EXPERIMENTAL

TQB2450

Intervention Type DRUG

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.

Anlotinib

Intervention Type DRUG

A multi-target receptor tyrosine kinase inhibitor.

Sunitinib Malate Capsules

Sunitinib malate capsule 50mg administered orally, once daily in 28-day cycle(14 days on treatment from Day 1-14, 14 days off treatment from day 15-28).

Group Type ACTIVE_COMPARATOR

Sunitinib

Intervention Type DRUG

A multi-target receptor tyrosine kinase inhibitor.

Interventions

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TQB2450

Intervention Type DRUG

Anlotinib

A multi-target receptor tyrosine kinase inhibitor.

Intervention Type DRUG

Sunitinib

A multi-target receptor tyrosine kinase inhibitor.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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