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

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04574284

Collaborator

(none)

196

Enrollment

Locations

Arms

Anticipated Duration (Months)

5.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Endometrial Cancer	Drug: TQB2450 Drug: Anlotinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

196 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 29, 2020

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: 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).

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.

Experimental: TQB2450

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

Drug: TQB2450

Experimental: 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).

Drug: Anlotinib

A multi-target receptor tyrosine kinase inhibitor.

Outcome Measures

Primary Outcome Measures

Overall response rate (ORR) evaluated by Independent Review Committee(IRC) [up to 12 months]
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.

Secondary Outcome Measures

Overall response rate (ORR) evaluated by investigator [up to 12 months]
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.
Disease control rate (DCR) [up to 12 months]
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Duration of response (DOR) [up to 12 months]
The time when the participants first achieved complete or partial remission to disease progression.
Progression free survival(PFS) [up to 12 months]
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause.
Overall survival(OS) [up to 18 months]
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.
DOR rate (≥ 6 months) [up to 6 months]
The percentage of participants achieved complete or partial remission ≥ 6 months.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

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.

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anhui Provincial Hospital	Hefei	Anhui	China	230001
2	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui	China	230601
3	Beijing Chao-Yang Hospital, Capital Medical University	Beijing	Beijing	China	100016
4	Beijing Obstetrics and Gynecology Hospital, Capital Medical University	Beijing	Beijing	China	100016
5	Peking Union Medical College Hospital	Beijing	Beijing	China	100730
6	Tsinghua University Affiliated Beijing Tsinghua Changgung Hospital	Beijing	Beijing	China	101100
7	Beijing Luhe Hospital Capital Medical University	Beijing	Beijing	China	101149
8	Chongqing University Cancer Hospital	Chongqing	Chongqing	China	400030
9	Gansu Provincial Hospital	Lanzhou	Gansu	China	730000
10	Lanzhou University Second Hospital	Lanzhou	Gansu	China	730030
11	Gansu Province Maternity and Chid-care Hospital	Lanzhou	Gansu	China	730050
12	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong	China	510080
13	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510289
14	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi	China	530022
15	Affiliated Hospital of Hebei University	Baoding	Hebei	China	071002
16	Henan Cancer Hospital	Zhengzhou	Henan	China	4500003
17	Hunan Cancer Hospital	Changsha	Hunan	China	410013
18	Nanjing Drum Tower Hospital	Nanjing	Jiangsu	China	210009
19	Liaoning Cancer Hospital	Shenyang	Liaoning	China	110041
20	Binzhou Medical University Hospital	Binzhou	Shandong	China	256600
21	Linyi Cancer Hospital	Linyi	Shandong	China	276034
22	Qingdao Central Hospital	Qingdao	Shandong	China	266042
23	Weifang People's Hospital	Weifang	Shandong	China	261000
24	Yantai Yuhuangding Hospital	Yantai	Shandong	China	264000
25	Obstetrics & Gynecology Hospital of Fudan University	Shanghai	Shanghai	China	200090
26	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China
27	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi	China	030001
28	Xi'an People's Hospital	Xi'an	Shanxi	China	710004
29	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China	710061
30	Tianjin Central Hospital of Gynecology Obstetrics	Tianjin	Tianjin	China	300052
31	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin	China	300060
32	First Affiliated Hospital, School of Medicine, Shihezi University	Shihezi	Xinjiang Uygur Autonomous Region	China	832008
33	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang Uygur Autonomous Region	China	830000
34	Xinjiang Medical University Affiliated Tumor Hospital	Urumqi	Xinjiang Uygur Autonomous Region	China	830000
35	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310000
36	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang	China	317000

Sponsors and Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

ClinicalTrials.gov Identifier:

NCT04574284

Other Study ID Numbers:

TQB2450-II-08

First Posted:

Oct 5, 2020

Last Update Posted:

Aug 23, 2021

Last Verified:

Jun 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endometrial Neoplasms

Study Results

No Results Posted as of Aug 23, 2021