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A Study of TQB2450 Injection ...

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

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-29

Study Completion Date

2024-05-09

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.

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Detailed Description

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Conditions

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Advanced Endometrial Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

TQB2450

Intervention Type DRUG

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.

Anlotinib

Intervention Type DRUG

A multi-target receptor tyrosine kinase inhibitor.

TQB2450

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.

Group Type EXPERIMENTAL

TQB2450

Intervention Type DRUG

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).

Group Type EXPERIMENTAL

Anlotinib

Intervention Type DRUG

A multi-target receptor tyrosine kinase inhibitor.

Interventions

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TQB2450

Intervention Type DRUG

Anlotinib

A multi-target receptor tyrosine kinase inhibitor.

Intervention Type DRUG

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:

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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Anhui Provincial Hospital

Hefei, Anhui, China

Site Status