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NCT Number: NCT04523272

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Advanced Renal Cancer

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. Histopathologically confirmed renal clear cell cancer, including advanced renal cell carcinoma with clear cell components.
  • 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.
  • Adequate laboratory indicators. 6. Agree to provide at least 5 slices tumor tissue samples for biomarker detection.
  • 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.
  • Understood and signed an informed consent form.

Exclusion criteria

  • 1. Has symptomatic central nervous system (CNS) disease and / or cancerous meningitis, pia mater disease.
  • Has received anti-angiogenesis targeted therapy or targeted PD-1 and PD-L1 immunotherapy.
  • Has active virus, bacteria, fungal infection; Cardiovascular and cerebrovascular diseases; Gastrointestinal abnormalities; Immunodeficiency; Bleeding risk; Lung disease; Neurological or psychiatric disorders.
  • Has participated in other clinical trials within 30 days before randomization.
  • Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
  • 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.

Treatment and study plan

TQB2450

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

Drug

A multi-target receptor tyrosine kinase inhibitor.

Sunitinib

Drug

A multi-target receptor tyrosine kinase inhibitor.

Primary outcomes

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

    Time frame: up to 60 weeks

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

Secondary outcomes

  1. Progression free survival (PFS) evaluated by investigator

    Time frame: up to 60 weeks

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

  2. Overall survival (OS)

    Time frame: up to 60 weeks

    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.

  3. Disease control rate（DCR）

    Time frame: up to 60 weeks

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

  4. Duration of response（DOR）

    Time frame: up to 60 weeks

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

  5. Progression-free survival at 12 months

    Time frame: up to 12 months

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

  6. Overall survival at 12 months

    Time frame: up to 12 months

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

  7. Overall survival at 24 months

    Time frame: up to 24 months

    Percentage of participants whose OS has achieved at least 24 months.

Sponsors and collaborators

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study title

A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2020
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.