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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Endometrial Cancer

Intervention / Treatment
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* Drug: TQB2450
* Drug: Anlotinib


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 12 months | 
| Disease control rate (DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 12 months | 
| Duration of response (DOR) | The time when the participants first achieved complete or partial remission to disease progression. | up to 12 months | 
| Progression free survival(PFS) | 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) | 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) | The percentage of participants achieved complete or partial remission ≥ 6 months. | up to 6 months |