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A Study of TQB2450 Combined With Anlotinib in Subjects With Gynecological Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04236362
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : January 12, 2021
Information provided by (Responsible Party):
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary:
This is a single-arm, open-label, phase Ib clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib in subjects with gynecological cancer, including 34 ovarian cancer,34 endometrial cancer,22 cervical cancer.

Condition or disease Intervention/treatment Phase
Gynecological Cancer Drug: TQB2450 Drug: Anlotinib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib, Single Arm, Open-label Study of TQB2450 Combined With Anlotinib in Subjects With Relapsed / Refractory Gynecological Cancer
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : May 30, 2022

Arm Intervention/treatment
Experimental: TQB2450+Anlotinib
TQB2450 1200 mg IV on Day 1 of each 21-day cycle plus Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
Drug: TQB2450
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.

Drug: Anlotinib
A multi-target receptor tyrosine kinase inhibitor

Primary Outcome Measures :
  1. Objective Response Rate (ORR) [ Time Frame: up to 96 weeks ]
    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR)

Secondary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: up to 96 weeks ]
    PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.

  2. Duration of Response (DOR) [ Time Frame: up to 96 weeks ]
    Time from tumor first assessment to CR or PR to first assessment to PD (Progressive Disease) or death from any cause

  3. Disease control rate(DCR) [ Time Frame: up to 96 weeks ]
    Percentage of Participants Achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).

  4. Overall Survival (OS) [ Time Frame: up to 120 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Understood and signed an informed consent form;
  2. 18 years and older, male or female, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, life expectancy ≥ 3 months;
  3. Histologically confirmed, unresectable recurrent/metastatic advanced gynecologic cancer, including ovarian, endometrial, and cervical cancer;
  4. Subjects have received at least 1 line platinum-containing chemotherapy (minimum of 4 cycles of platinum-containing treatment) after tumor reduction, and meet any of the following:Platinum-resistant or refractory patients, including patients who have progressed or relapsed during previous platinum-containing chemotherapy regimens or within 6 months after the end of platinum-containing chemotherapy;
  5. At least one measurable lesion according to the RECIST 1.1;
  6. The main organs function are normally;
  7. Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

Exclusion Criteria:

  1. Has other non-epithelial ovarian tumors or borderline ovarian epithelial tumors;
  2. Other malignant tumors that have appeared or are currently present within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors;
  3. Has previously received immune drugs such as PD-1 / PD-L1, CTLA-4 or other tyrosine kinase inhibitors such as anlotinib hydrochloride;
  4. Has received bevacizumab within 28 days before the first dose;
  5. Has received chemotherapy, surgery, radiotherapy, the last treatment from the first dose less than 4 weeks, or oral targeted drugs for less than 5 half-lives, or oral fluorouracil pyridine drugs for less than 14 days, mitomycin C and nitrosourea for less than 6 weeks;
  6. Expect to use any active vaccine against infectious diseases (such as influenza vaccine, chickenpox vaccine, etc.) within 28 days before the first dose or during the study period;
  7. Patients diagnosed with immunodeficiency or undergoing systemic glucocorticoid therapy or any other form of immunosuppressive therapy (dose> 10mg / day prednisone or other effective hormones) and continue to use it within 2 weeks before the first dose;
  8. Active autoimmune diseases that require systemic treatment have occurred within 2 years before the first dose;
  9. Subjects known to be allergic to the study drug or any of its excipients or have experienced a severe allergic reaction to other monoclonal antibodies;
  10. Has uncontrollable symptoms of brain metastases, spinal cord compression, cancerous meningitis;
  11. Has any bleeding or bleeding event ≥ CTC AE Grade 3 or unhealed wounds, ulcers or fractures within 4 weeks before the first dose;
  12. Has clinically significant thyroid dysfunction before the first dose;
  13. Has multiple factors affecting oral medication;
  14. Has any severe acute complications before the first dose;
  15. Has participated in other anti-tumor intervention clinical trials within 4 weeks before the first medication;
  16. According to the judgement of the researchers, there are other factors that may lead to the termination of the study. For example, other serious diseases including mental disorders need to be treated together, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subjects, or the collection of data and samples.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04236362

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Contact: Xin Huang 020-87343014

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China, Beijing
The General Hospital of the People's Liberation Army Recruiting
Beijing, Beijing, China, 100039
Contact: Shunchang Jiao    13801380677   
Principal Investigator: Shunchang Jiao         
China, Chongqing
Cancer Hospital of Chongqing University Recruiting
Chongqing, Chongqing, China, 400030
Contact: Qi Zhou    13708384529   
Principal Investigator: Qi Zhou         
China, Gansu
The First Hospital of Lanzhou University Recruiting
Lanzhou, Gansu, China, 730000
Contact: Liu Chang   
Principal Investigator: Liu Chang         
China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510000
Contact: Xin Huang    020-87343014   
Principal Investigator: Xin Huang         
China, Hebei
First Hospital of Qinhuangdao Recruiting
Qinhuangdao, Hebei, China, 066000
Contact: Jin Haihong   
Principal Investigator: Jin Haihong         
Sponsors and Collaborators
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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Responsible Party: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. Identifier: NCT04236362    
Other Study ID Numbers: TQB2450-Ib-10
First Posted: January 22, 2020    Key Record Dates
Last Update Posted: January 12, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No