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

Last updated: May 26, 2025
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Overall Status: Completed

Phase

2

Condition

Endometrial Cancer

Treatment

TQB2450

Anlotinib

Clinical Study ID

NCT04574284
TQB2450-II-08
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Understood and signed an informed consent form. 2. Eastern Cooperative OncologyGroup (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.

  2. Histopathologically confirmed recurrent or metastatic advanced endometrialcancer.

  3. Has at least one measurable lesion. 5. Agree to provide tumor tissue samplesfor MSI/MMR status detection. 6. Adequate laboratory indicators. 7. Serum orurine pregnancy tests are negative within 7 days before randomization; Men andwomen should agree to use effective contraception during the study period andafter the end of the study period within 6 months.

Exclusion

Exclusion Criteria:

  • 1.Concomitant disease and medical history:
  1. Has diagnosed and/or treated additional malignancy within 3 years prior torandomization;

  2. Pathological diagnosed as uterine sarcoma;

  3. Has multiple factors affecting oral medication;

  4. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy.

  5. Has received major surgical treatment, open biopsy and so on within 28 daysbefore the start of the study.

  6. Has a unhealed wound or fracture for a long time;

  7. Has cerebrovascular accident, deep vein thrombosis and pulmonary embolismwithin 6 months before the study;

  8. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiringrecurrent drainage procedures;

  9. Has a history of psychotropic substance abuse and unable to quit or mentaldisorders;

  10. Has any serious and / or uncontrolled disease; 2. Tumor-related symptoms andtreatment:

  11. Has received surgery, chemotherapy, radiotherapy or other anticancer therapywithin 4 weeks before the start of the study;

  12. Has received proprietary Chinese medicine with anti-tumor indications in theNMPA approved drug instructions within 2 weeks before the start of the study;

  13. Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and otherrelated drugs;

  14. Has used antiangiogenic drugs such as bevacizumab, anlotinib, apatinib,lenvatinib, sorafenib, Sunitinib, regorafenib, fruquintinib, etc;

  15. Has received hormone therapy for endometrial cancer within a week before thefirst dose ;

  16. CT or MRI showed that the tumor had invaded the important blood vessels;

  17. Has symptomatic central nervous system (CNS) disease and/or cancerousmeningitis, pia mater disease; 3. Related to research and treatment:

  18. Has received attenuated live vaccine within 28 days before randomization orplanned to received attenuated live vaccine during the study period.

  19. Has a history of severe allergic diseases.

  20. Has active autoimmune diseases requiring systemic treatment occurred within 2years before the study.

  21. Has Participated in other clinical trials within 4 weeks before firstdose. 5. According to the judgement of the investigators, there are otherfactors that may lead to the termination of the study.

Study Design

Total Participants: 170
Treatment Group(s): 2
Primary Treatment: TQB2450
Phase: 2
Study Start date:
September 29, 2020
Estimated Completion Date:
May 09, 2024

Connect with a study center

  • Anhui Provincial Hospital

    Hefei, Anhui 230001
    China

    Site Not Available

  • The Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • Beijing Chao-Yang Hospital, Capital Medical University

    Beijing, Beijing 100016
    China

    Site Not Available

  • Beijing Luhe Hospital Capital Medical University

    Beijing, Beijing 101149
    China

    Site Not Available

  • Beijing Obstetrics and Gynecology Hospital, Capital Medical University

    Beijing, Beijing 100016
    China

    Site Not Available

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

  • Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 101100
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400030
    China

    Site Not Available

  • Gansu Province Maternity and Chid-care Hospital

    Lanzhou, Gansu 730050
    China

    Site Not Available

  • Gansu Provincial Hospital

    Lanzhou, Gansu 730000
    China

    Site Not Available

  • Lanzhou University Second Hospital

    Lanzhou, Gansu 730030
    China

    Site Not Available

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

    Guangzhou, Guangdong 510289
    China

    Site Not Available

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong 510080
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi 530022
    China

    Site Not Available

  • Affiliated Hospital of Hebei University

    Baoding, Hebei 071002
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 4500003
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia 010000
    China

    Site Not Available

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu 210009
    China

    Site Not Available

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Site Not Available

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 110041
    China

    Site Not Available

  • Binzhou Medical University Hospital

    Binzhou, Shandong 256600
    China

    Site Not Available

  • Linyi Cancer Hospital

    Linyi, Shandong 276034
    China

    Site Not Available

  • Qingdao Central Hospital

    Qingdao, Shandong 266042
    China

    Site Not Available

  • Weifang People's Hospital

    Weifang, Shandong 261000
    China

    Site Not Available

  • Yantai Yuhuangding Hospital

    Yantai, Shandong 264000
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai
    China

    Site Not Available

  • Obstetrics & Gynecology Hospital of Fudan University

    Shanghai, Shanghai 200090
    China

    Site Not Available

  • Second Hospital of Shanxi Medical University

    Taiyuan, Shanxi 030001
    China

    Site Not Available

  • First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shanxi 710061
    China

    Site Not Available

  • Xi'an People's Hospital

    Xi'an, Shanxi 710004
    China

    Site Not Available

  • Tianjin Central Hospital of Gynecology Obstetrics

    Tianjin, Tianjin 300052
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • First Affiliated Hospital, School of Medicine, Shihezi University

    Shihezi, Xinjiang Uygur Autonomous Region 832008
    China

    Site Not Available

  • The First Affiliated Hospital of Xinjiang Medical University

    Urumqi, Xinjiang Uygur Autonomous Region 830000
    China

    Site Not Available

  • Xinjiang Medical University Affiliated Tumor Hospital

    Urumqi, Xinjiang Uygur Autonomous Region 830000
    China

    Site Not Available

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang Province

    Taizhou, Zhejiang 317000
    China

    Site Not Available

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