AzTrials
AzTrials

Advanced Renal CancerPhase 3NCT04523272

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

A Phase 3 study testing TQB2450, Anlotinib and Sunitinib in people with Advanced Renal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 39 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Renal Cancer
What is being tested?
TQB2450, Anlotinib and Sunitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
528 participants
Where
39 sitesChina
Study dates
25 Aug 2020to Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

China39 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100191

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Cancer Hospital

    Changsha, Hunan, 410006

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

  • The First Affiliated Hospital of the Chinese People's Liberation Army Army Medical University

    Chongqing, Chongqing Municipality, 400000

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400042

  • The Second Hospital of Dalian Medical University

    Dalian, Liaoning, 116027

  • Fujian Provincial Hospital

    Fuzhou, Fujian, 350001

  • The First Affiliated Hospital of Fujian Medical University

    Fuzhou, Fujian, 350004

  • Sun Yat-sen of Cancer Center

    Guangzhou, Guangdong, 510060

  • Cancer Hospital of The University of Chinese Academy of Sciences

    Hangzhou, Zhejiang, 310000

  • The Affiliated Tumor Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150081

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, 314001

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250012

  • First Hospital of Lanzhou University

    Lanzhou, Gansu, 730013

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330038

  • The Affiliated Hospital of Nanjing University Medical School

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 212028

  • Tenth People's Hospital of Tongji University

    Shanghai, Shanghai Municipality, 200072

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning, 110042

  • First Affiliated Hospital,School of Medicine,Shihezi University

    Shihezi, Xinjiang, 832008

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

  • Second Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300211

  • The Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830000

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang, 830054

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430014

  • The Second Affiliated Hospital of Xi 'an Jiaotong University

    Xi’an, Shanxi, 710004

  • The First Affiliated Hospital of PLA Air Force Military Medical University

    Xi’an, Shanxi, 711400

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264099

Other trials in China

About this study

Official 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

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.

Being tested
TQB2450, Anlotinib, Sunitinib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT04523272
Study groupRoleWhat they receive
TQB2450 + AnlotinibExperimentalTQB2450 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).
Receives: Drug: TQB2450; Drug: Anlotinib
Sunitinib Malate CapsulesActive comparatorSunitinib 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).
Receives: Drug: Sunitinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 60 weeks

Secondary outcomes (7)

  1. 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.

    Measured: up to 60 weeks

  2. 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.

    Measured: up to 60 weeks

  3. Disease control rate（DCR）

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

    Measured: up to 60 weeks

  4. Duration of response（DOR）

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

    Measured: up to 60 weeks

  5. Progression-free survival at 12 months

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

    Measured: up to 12 months

  6. Overall survival at 12 months

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

    Measured: up to 12 months

  7. Overall survival at 24 months

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

    Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2020
  2. Study start25 Aug 2020
  3. Primary completionJun 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
528 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04523272
Sponsor's protocol ID
TQB2450-III-07
Status last verified
Oct 2024
First submitted
20 Aug 2020
Last updated
15 Oct 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Li J, Tian H, Xu H, Yan X, Tang B, Li S, Zhou L, Wu X, Chi Z, Cui C, Si L, Guo J, Sheng X. Evaluation and analysis of renal injury in patients with advanced renal cell carcinoma receiving first-line benmelstobart plus anlotinib: results from the ETER100 study. BMC Med. 2026 Jul 1. doi: 10.1186/s12916-026-05026-0. Online ahead of print.

    PubMed 42387482

  • Zhou A, Shen P, Li J, Qu W, Wang Z, Ren X, Li Y, Jiang S, Li G, Zeng Y, Qin W, Wu J, Chen P, Zhou F, Guo H, Ji Z, Wang Y, He Z, Wu J, Shi B, Liu L, Yao X, Ma L, Liu Z, Gou X, Fu B, Wang S, Jiang K, Chong T, Tu X, Zhang X, Yu D, Rexiati M, Xue X, Fei J, Wan J, Jia L, He Y, Cui T, Yang AQ, Guo J, Sheng X. First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma (ETER100): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Sep;26(9):1145-1157. doi: 10.1016/S1470-2045(25)00343-2.

    PubMed 40907513

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing TQB2450, Anlotinib and Sunitinib in people with Advanced Renal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 39 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) evaluated by Independent Review Committee(IRC) (time frame: up to 60 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04523272, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in