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

NCT04574284 | Completed Phase 2

• 1 other identifier: TQB2450-II-08
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 36

Brief 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.

Conditions

Advanced Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Overall response rate (ORR) evaluated by investigator

  up to 12 months

• Disease control rate (DCR)

  up to 12 months

• Duration of response (DOR)

  up to 12 months

• Progression free survival(PFS)

  up to 12 months

• Overall survival(OS)

  up to 18 months

Study Arms (3)

TQB2450 + Anlotinib

EXPERIMENTAL

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; Drug: Anlotinib

TQB2450

EXPERIMENTAL

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

Drug: TQB2450

Anlotinib

EXPERIMENTAL

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

Interventions

TQB2450 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.

TQB2450; TQB2450 + Anlotinib

Anlotinib DRUG

A multi-target receptor tyrosine kinase inhibitor.

Anlotinib; TQB2450 + Anlotinib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Understood and signed an informed consent form. 2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months.
• \. Histopathologically confirmed recurrent or metastatic advanced endometrial cancer.
• \. 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.

You may not qualify if:

• 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:
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• 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;

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (36)

Anhui Provincial Hospital

Hefei, Anhui, 230001, China

Location

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

Beijing Chao-Yang Hospital, Capital Medical University

Beijing, Beijing Municipality, 100016, China

Location

Beijing Obstetrics and Gynecology Hospital, Capital Medical University

Beijing, Beijing Municipality, 100016, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 101100, China

Location

Beijing Luhe Hospital Capital Medical University

Beijing, Beijing Municipality, 101149, China

Location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Gansu Provincial Hospital

Lanzhou, Gansu, 730000, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

Gansu Province Maternity and Chid-care Hospital

Lanzhou, Gansu, 730050, China

Location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510080, China

Location

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

Guangzhou, Guangdong, 510289, China

Location

Guangxi Medical University Affiliated Tumor Hospital

Nanning, Guangxi, 530022, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, 071002, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 4500003, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

Location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210009, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, 110041, China

Location

Binzhou Medical University Hospital

Binzhou, Shandong, 256600, China

Location

Linyi Cancer Hospital

Linyi, Shandong, 276034, China

Location

Qingdao Central Hospital

Qingdao, Shandong, 266042, China

Location

Weifang People's Hospital

Weifang, Shandong, 261000, China

Location

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

Location

Obstetrics & Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200090, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Location

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Xi'an People's Hospital

Xi’an, Shanxi, 710004, China

Location

First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Tianjin Central Hospital of Gynecology Obstetrics

Tianjin, Tianjin Municipality, 300052, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

First Affiliated Hospital, School of Medicine, Shihezi University

Shihezi, Xinjiang Uygur Autonomous Region, 832008, China

Location

The First Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

Location

Xinjiang Medical University Affiliated Tumor Hospital

Ürümqi, Xinjiang Uygur Autonomous Region, 830000, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310000, China

Location

Taizhou Hospital of Zhejiang Province

Taizhou, Zhejiang, 317000, China

Location

MeSH Terms

Interventions

anlotinib

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2020
• First Posted: October 5, 2020
• Study Start: September 29, 2020
• Primary Completion: November 9, 2023
• Study Completion: May 9, 2024
• Last Updated: May 28, 2025

Record last verified: 2025-05

Locations

CN (36)