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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

196

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Weidong Zhao, Doctor
      • Hefei, Anhui, China, 230601
        • Not yet recruiting
        • The Second Affiliated Hospital of Anhui Medical University
        • Contact:
        • Principal Investigator:
          • Zhendong Chen
    • Beijing
      • Beijing, Beijing, China, 100730
        • Not yet recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Principal Investigator:
          • Lingya Pan, Doctor
      • Beijing, Beijing, China, 100016
        • Not yet recruiting
        • Beijing Chao-Yang Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Shuzhen Wang, Doctor
      • Beijing, Beijing, China, 100016
        • Not yet recruiting
        • Beijing Obstetrics and Gynecology Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • Wei Duan, Doctor
      • Beijing, Beijing, China, 101100
        • Not yet recruiting
        • Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital
        • Contact:
        • Principal Investigator:
          • Qinping Liao, Doctor
      • Beijing, Beijing, China, 101149
        • Not yet recruiting
        • Beijing Luhe Hospital Capital Medical University
        • Contact:
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • Lanzhou University Second Hospital
        • Contact:
        • Principal Investigator:
          • Pengfei Sun, doctor
      • Lanzhou, Gansu, China, 730000
        • Not yet recruiting
        • Gansu Provincial Hospital
        • Contact:
        • Principal Investigator:
          • Tiansheng Qing, doctor
        • Principal Investigator:
          • Hongyi Cai, doctor
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • Gansu Province Maternity and Chid-care Hospital
        • Contact:
        • Principal Investigator:
          • Qing Liu, doctor
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Jundong Li, Master
      • Guangzhou, Guangdong, China, 510289
        • Not yet recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
        • Principal Investigator:
          • Bingzhong Zhang, Doctor
    • Guangxi
      • Nanning, Guangxi, China, 530022
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Deisheng Yao, Doctor
    • Hebei
      • Baoding, Hebei, China, 071002
        • Not yet recruiting
        • Affiliated Hospital of Hebei University
        • Principal Investigator:
          • Aimin Zang
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 4500003
        • Not yet recruiting
        • Henan Cancer Hospital
        • Principal Investigator:
          • li wang
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Jing Wang, Doctor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Not yet recruiting
        • Nanjing Drum Tower Hospital
        • Contact:
        • Principal Investigator:
          • Huaijun Zhou, Doctor
    • Liaoning
      • Shenyang, Liaoning, China, 110041
        • Not yet recruiting
        • Liaoning Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Danbo Wang, Doctor
    • Shandong
      • Binzhou, Shandong, China, 256600
        • Not yet recruiting
        • Binzhou Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Fangling Ning
      • Linyi, Shandong, China, 276034
        • Not yet recruiting
        • Linyi Cancer Hospital
        • Principal Investigator:
          • Xiumin Li
        • Contact:
      • Qingdao, Shandong, China, 266042
        • Not yet recruiting
        • Qingdao Central Hospital
        • Contact:
        • Principal Investigator:
          • Li Sun, Doctor
      • Weifang, Shandong, China, 261000
        • Not yet recruiting
        • Weifang People'S Hospital
        • Principal Investigator:
          • Guohua Yu
        • Contact:
      • Yantai, Shandong, China, 264000
        • Not yet recruiting
        • Yantai Yuhuangding Hospital
        • Contact:
        • Principal Investigator:
          • Jianqing Hou, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200090
        • Recruiting
        • Obstetrics & Gynecology Hospital of Fudan University
        • Contact:
        • Principal Investigator:
          • Xiaojun Chen, Doctor
      • Shanghai, Shanghai, China
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Principal Investigator:
          • Xiaohua Wu, Doctor
    • Shanxi
      • Taiyuan, Shanxi, China, 030001
        • Not yet recruiting
        • Second Hospital of Shanxi Medical University
        • Contact:
          • Min Hao, Doctor
        • Principal Investigator:
          • Min Hao, D
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • First Affiliated Hospital of Xi'an JiaoTong University
        • Contact:
        • Principal Investigator:
          • Ruifang An, Doctor
      • Xi'an, Shanxi, China, 710004
        • Not yet recruiting
        • Xi'an People's Hospital
        • Contact:
        • Principal Investigator:
          • Xinwen Fang, doctor
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Not yet recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Contact:
        • Principal Investigator:
          • Ke Wang, Master
      • Tianjin, Tianjin, China, 300052
        • Not yet recruiting
        • Tianjin Central Hospital of Gynecology obstetrics
        • Contact:
        • Principal Investigator:
          • Pengpeng Qu, Doctor
    • Xinjiang Uygur Autonomous Region
      • Shihezi, Xinjiang Uygur Autonomous Region, China, 832008
        • Recruiting
        • First Affiliated Hospital, School of Medicine, Shihezi University
        • Principal Investigator:
          • Ping Gong, Doctor
        • Contact:
      • Urumqi, Xinjiang Uygur Autonomous Region, China, 830000
        • Not yet recruiting
        • The First Affiliated Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Cailing Ma, Doctor
      • Urumqi, Xinjiang Uygur Autonomous Region, China, 830000
        • Not yet recruiting
        • Xinjiang Medical University Affiliated Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Jianlin Yuan
        • Principal Investigator:
          • Gulina Kuerban
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Hanmei Lou
      • Taizhou, Zhejiang, China, 317000
        • Not yet recruiting
        • Taizhou Hospital of Zhejiang Province
        • Contact:
        • Principal Investigator:
          • Haihua Yang, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 1.Concomitant disease and medical history:

    1. Has diagnosed and/or treated additional malignancy within 3 years prior to randomization;
    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 days before 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 embolism within 6 months before the study;
    8. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures;
    9. Has a history of psychotropic substance abuse and unable to quit or mental disorders;
    10. Has any serious and / or uncontrolled disease; 2. Tumor-related symptoms and treatment:
    1. Has received surgery, chemotherapy, radiotherapy or other anticancer therapy within 4 weeks before the start of the study;
    2. Has received proprietary Chinese medicine with anti-tumor indications in the NMPA approved drug instructions within 2 weeks before the start of the study;
    3. Has received immunotherapeutic drugs against PD-1, PD-L1, CTLA-4 and other related drugs;
    4. Has used antiangiogenic drugs such as bevacizumab, anlotinib, apatinib, lenvatinib, sorafenib, Sunitinib, regorafenib, fruquintinib, etc;
    5. Has received hormone therapy for endometrial cancer within a week before the first dose ;
    6. CT or MRI showed that the tumor had invaded the important blood vessels;
    7. Has symptomatic central nervous system (CNS) disease and/or cancerous meningitis, pia mater disease; 3. Related to research and treatment:
    1. Has received attenuated live vaccine within 28 days before randomization or planned to received attenuated live vaccine during the study period.
    2. Has a history of severe allergic diseases.
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
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.
A multi-target receptor tyrosine kinase inhibitor.
Experimental: TQB2450
TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
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.
Experimental: Anlotinib
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).
A multi-target receptor tyrosine kinase inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) evaluated by Independent Review Committee(IRC)
Time Frame: up to 12 months
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.
up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) evaluated by investigator
Time Frame: up to 12 months
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.
up to 12 months
Disease control rate (DCR)
Time Frame: up to 12 months
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
up to 12 months
Duration of response (DOR)
Time Frame: up to 12 months
The time when the participants first achieved complete or partial remission to disease progression.
up to 12 months
Progression free survival(PFS)
Time Frame: up to 12 months
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
up to 12 months
Overall survival(OS)
Time Frame: up to 18 months
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.
up to 18 months
DOR rate (≥ 6 months)
Time Frame: up to 6 months
The percentage of participants achieved complete or partial remission ≥ 6 months.
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 29, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

September 30, 2020

First Posted (Actual)

October 5, 2020

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 17, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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