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Advanced Endometrial CancerPhase 2NCT04574284

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer

A Phase 2 study testing TQB2450 and Anlotinib in people with Advanced Endometrial Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 36 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a study to evaluate the efficacy and safety of TQB2450 injection or combined with anlotinib hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Advanced Endometrial Cancer
What is being tested?
TQB2450 and Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
36 sitesChina
Study dates
29 Sep 2020to 9 May 2024
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Understood and signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
  • 3. Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.
  • 4. Has at least one measurable lesion. 5. Agree to provide tumor tissue samples for MSI/MMR status detection. 6. Adequate laboratory indicators. 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.

Who cannot join

  • 1.Concomitant disease and medical history:
  • Has diagnosed and/or treated additional malignancy within 3 years prior to randomization;
  • Pathological diagnosed as uterine sarcoma;
  • Has multiple factors affecting oral medication;
  • Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy.
  • Has received major surgical treatment, open biopsy and so on within 28 days before the start of the study.
Show all 24Show fewer
  • Has a unhealed wound or fracture for a long time;
  • Has cerebrovascular accident, deep vein thrombosis and pulmonary embolism within 6 months before the study;
  • Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
  • Has a history of psychotropic substance abuse and unable to quit or mental disorders;
  • Has any serious and / or uncontrolled disease; 2. Tumor-related symptoms and treatment:
  • <!-- -->
  • Has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study;
  • Has received proprietary Chinese medicine with anti-tumor indications in the NMPA approved drug instructions within 2 weeks before the start of the study;
  • Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and other related drugs;
  • Has used antiangiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, Sunitinib, regorafenib, fruquintinib, etc;
  • Has received hormone therapy for endometrial cancer within a week before the first dose ;
  • CT or MRI showed that the tumor had invaded the important blood vessels;
  • Has symptomatic central nervous system (CNS) disease and/or cancerous meningitis, pia mater disease; 3. Related to research and treatment:
  • <!-- -->
  • Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
  • Has a history of severe allergic diseases.
  • Has active autoimmune diseases requiring systemic treatment occurred within 2 years before the study.
  • 4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Trial locations and contacts

36 sites in 1 country.

36 sites in 1 country

China36 sites

  • Affiliated Hospital of Hebei University

    Baoding, Hebei, 071002

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100016

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100016

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 101100

  • Beijing Luhe Hospital Capital Medical University

    Beijing, Beijing Municipality, 101149

  • Binzhou Medical University Hospital

    Binzhou, Shandong, 256600

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510080

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510289

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

  • Anhui Provincial Hospital

    Hefei, Anhui, 230001

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230601

  • Gansu Provincial Hospital

    Lanzhou, Gansu, 730000

  • Lanzhou University Second Hospital

    Lanzhou, Gansu, 730030

  • Gansu Province Maternity and Chid-care Hospital

    Lanzhou, Gansu, 730050

  • Linyi Cancer Hospital

    Linyi, Shandong, 276034

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210009

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530022

  • Qingdao Central Hospital

    Qingdao, Shandong, 266042

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai Municipality, 200090

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110041

  • First Affiliated Hospital, School of Medicine, Shihezi University

    Shihezi, Xinjiang Uygur Autonomous Region, 832008

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang, 317000

  • Tianjin Central Hospital of Gynecology Obstetrics

    Tianjin, Tianjin Municipality, 300052

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Xinjiang Medical University

    Ürümqi, Xinjiang Uygur Autonomous Region, 830000

  • Xinjiang Medical University Affiliated Tumor Hospital

    Ürümqi, Xinjiang Uygur Autonomous Region, 830000

  • Weifang People's Hospital

    Weifang, Shandong, 261000

  • Xi'an People's Hospital

    Xi’an, Shanxi, 710004

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, 264000

  • Henan Cancer Hospital

    Zhengzhou, Henan, 4500003

Other trials in China

About this study

Official title: A Open-label, Multicenter Phase II Study of TQB2450 Injection or Combined With Anlotinib Hydrochloride Capsule in Subjects With Advanced Endometrial Cancer

This is a study to evaluate the efficacy and safety of TQB2450 injection or combined with anlotinib hydrochloride capsule in the treatment of recurrent or metastatic advanced endometrial cancer.

Being tested
TQB2450, Anlotinib

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.

Study groups in NCT04574284
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
TQB2450ExperimentalTQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
Receives: Drug: TQB2450
AnlotinibExperimentalAnlotinib 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: Anlotinib

What is being measured

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

  1. Overall response rate (ORR) evaluated by Independent Review Committee(IRC)

    ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on IRC.

    Measured: up to 12 months

Secondary outcomes (6)

  1. Overall response rate (ORR) evaluated by investigator

    ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.

    Measured: up to 12 months

  2. Disease control rate (DCR)

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

    Measured: up to 12 months

  3. Duration of response (DOR)

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

    Measured: up to 12 months

  4. Progression free survival(PFS)

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

    Measured: up to 12 months

  5. 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 18 months

  6. DOR rate (≥ 6 months)

    The percentage of participants achieved complete or partial remission ≥ 6 months.

    Measured: up to 6 months

Timeline

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

  1. First posted5 Oct 2020
  2. Study start29 Sep 2020
  3. Primary completion9 Nov 2023
  4. Study completion9 May 2024

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04574284
Sponsor's protocol ID
TQB2450-II-08
Status last verified
May 2025
First submitted
30 Sep 2020
Last updated
28 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Liang S, Chen X, Wang K, Wang D, An R, Hou J, Yang Y, Wang D, Qu P, Zhang B, Duan W, Li X, Zang A, Yu G, Lou H, Yao D, Wang S, Yan D, Li L, Liu X, Zhao W, Chen Z, Fei J, Li J, Wang J, Wang Z, Yao S, Ning F, Zhou H, Sun L, Pan L, Liu Q, Yang H, Wang L, Zhang M, Chen X, Yuan J, Zhang X, Zhang Y, Liao Q, Wu X. Efficacy and Safety of Benmelstobart Plus Anlotinib in Advanced Endometrial Cancer: Results of a Multi-Cohort, Phase II Study (ETER200). MedComm (2020). 2026 Oct 21;7(11):e71081. doi: 10.1002/mco2.71081. eCollection 2026 Nov.

    PubMed 42910366

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TQB2450 and Anlotinib in people with Advanced Endometrial Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 36 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 3 inclusion and 24 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: finished, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall response rate (ORR) evaluated by Independent Review Committee(IRC) (time frame: up to 12 months). 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 NCT04574284, which also lists 1 linked publication.

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 28 May 2025.

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