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

Advanced Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04574284
• Other study ID #: TQB2450-II-08
• Status: Recruiting
• Phase: Phase 2
• Start date: September 29, 2020
• Est. completion date: April 30, 2022

Study information

• Verified date: June 2021
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Xiaohua Wu, Doctor
• Email: wu.xh[@]fudan.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 196
• Est. completion date: April 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Endometrial Cancer
• Endometrial Neoplasms

Intervention

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.
• Anlotinib
A multi-target receptor tyrosine kinase inhibitor.

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Luhe Hospital Capital Medical University	Beijing	Beijing
China	Beijing Obstetrics and Gynecology Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	Binzhou Medical University Hospital	Binzhou	Shandong
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	Gansu Province Maternity and Chid-care Hospital	Lanzhou	Gansu
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	Linyi Cancer Hospital	Linyi	Shandong
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	Qingdao Central Hospital	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	First Affiliated Hospital, School of Medicine, Shihezi University	Shihezi	Xinjiang Uygur Autonomous Region
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	Tianjin Central Hospital of Gynecology Obstetrics	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang Uygur Autonomous Region
China	Xinjiang Medical University Affiliated Tumor Hospital	Urumqi	Xinjiang Uygur Autonomous Region
China	Weifang People's Hospital	Weifang	Shandong
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xi'an People's Hospital	Xi'an	Shanxi
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Disease control rate (DCR)	Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).	up to 12 months
Secondary	Duration of response (DOR)	The time when the participants first achieved complete or partial remission to disease progression.	up to 12 months
Secondary	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
Secondary	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
Secondary	DOR rate (= 6 months)	The percentage of participants achieved complete or partial remission = 6 months.	up to 6 months