Anlotinib Hydrochloride Capsules Combined With TQB2450 in the Treatment of Endometrial Cancer
Efficacy of Anlotinib Hydrochloride Capsules Combined With TQB2450 in the Treatment of Endometrial Cancer in a Randomized, Controlled, Open-label, Multicenter Phase III Clinical Trial
1 other identifier
interventional
420
1 country
61
Brief Summary
To demonstrate that anlotinib hydrochloride capsules combined with TQB2450 injection can significantly prolong progression-free survival (PFS) compared with chemotherapy in patients with recurrent or metastatic endometrial cancer that is non- microsatellite instability high (non-MSI-H) or DNA mismatch repair deficient (non-dMMR).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2024
Longer than P75 for phase_3
61 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2024
CompletedFirst Posted
Study publicly available on registry
June 26, 2024
CompletedStudy Start
First participant enrolled
July 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
June 27, 2024
January 1, 2024
3.4 years
June 21, 2024
June 26, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) assessed by independent imaging review committee (IRC)
Progression-free survival (PFS) as assessed by independent imaging review committee (IRC) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST1.1) criteria. Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first.
Up to 36 months after study start
Secondary Outcomes (12)
Overall survival (OS)
Up to 36 months after study start
Progression-free survival (PFS) assessed by investigators
Up to 36 months after study start
Objective mitigation rate (ORR)
Up to 36 months after study start
Duration of Response (DOR)
Up to 36 months after study start
Disease control rate (DCR)
Up to 36 months after study start
- +7 more secondary outcomes
Study Arms (2)
Anlotinib hydrochloride capsules + TQB2450 injection
EXPERIMENTALAnlotinib hydrochloride capsule: 12 mg each time, once a day, oral administration before breakfast, continuous oral administration for 2 weeks and stop for 1 week. TQB2450 injection: 1200mg/ time, once every 3 weeks, diluted to 250 mL with normal saline, infusion time was 60±10 minute.
Chemotherapy drug
ACTIVE COMPARATORBased on each patient's condition and previous treatment history, the investigator will select one of the following chemotherapy drugs for treatment. Paclitaxel: dose of 175 mg /㎡, Day 1, every 4 weeks (Q4W). Albumin-bound paclitaxel: dose of 125 mg /㎡, Day 1, Day 8, Day 15, every 4 weeks (Q4W). Doxorubicin: dose 60mg/m ², Day1, every 3 weeks (Q3W). Doxorubicin liposome: dose 40mg/ m ²,Day 1, every 4 weeks (Q4W).
Interventions
Anlotinib hydrochloride capsule is a multi-target tyrosine kinase inhibitor, which targets VEGFR (VEGFR-1, VEGFR-2 and VEGFR-3), PDGFR, FGFR and c-Kit, etc. It can inhibit tumor progression by inhibiting angiogenesis and tumor growth at the same time. TQB2450 injection is a humanized monoclonal antibody targeting programmed death ligand 1 (PD-L1) that prevents the binding of PD-L1 to the PD-1 and B7.1 receptors on the T-cell surface, allowing T-cell reactivation and thus enhancing the immune response.
Based on each patient's condition and previous treatment history, the investigator will select one of the chemotherapy drugs (including Paclitaxel, Albumin, Doxorubicin and Doxorubicin hydrochloride) for treatment.
Eligibility Criteria
You may qualify if:
- Recurrent or metastatic advanced endometrial cancer confirmed by histopathology;
- Patients failed to respond to 1-2 lines of platinum-based doublet-based therapy;
- Provide a traceable MMR/MSI status report or provide biological samples for DNA mismatch repair/microsatellite instability (MMR/MSI) status testing with non-MSI-high (non-MSI-H) or non-dMMR；
- Patients who cannot undergo radical surgery/radiotherapy;
- Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score: 0-1; The expected survival time is more than 3 months；
- At least one measurable lesion (RECIST 1.1);
- Good function of the major organs；
- Women of childbearing age should agree that they must use a contraceptive method (e.g. Intra-uterine device (IUD), contraceptive pill, or condom) during the study and for 6 months after the study; A negative serum pregnancy test within 7 days before study entry and must be non-lactating；
- Subjects voluntarily joined this study, signed informed consent, and had good compliance；
You may not qualify if:
- Previous use of bevacizumab, endostar, anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, regorafenib, fruquintinib and other anti-angiogenic drugs or immunotherapy drugs targeting programmed cell death protein 1 (PD-1), PD-L1 and other related cells；
- Patients received anti-tumor indications of Chinese patent medicine approved by National Medical Products Administration (NMPA) within 2 weeks before the study treatment；
- Pathology suggested carcinosarcoma (malignant mullerian mixed tumor), endometrial leiomyosarcoma or other high-grade sarcoma, or endometrial stromal sarcoma；
- Hormone therapy for endometrial cancer had been received within 1 week before the first dose of trial medication；
- Surgery, chemotherapy, radiation therapy, or other anticancer therapy had been received within 4 weeks before the initiation of study treatment (the washout period was calculated from the end of the last treatment). The half-life of oral targeted drugs was less than 5 drugs；
- Subjects with known central nervous system metastases and/or carcinomatous meningitis; The patients were not asymptomatic or were treated and stable, had no radiographic evidence of new or expanding brain metastases for at least 2 weeks after treatment for brain metastases, and had discontinued steroids or anticonvulsant therapy for at least 14 days before the initiation of study treatment；
- The patient had developed or had concurrent malignant tumors within the past 3 years；
- Multiple factors that affect the oral administration of anlotinib (e.g., inability to swallow, post-gastrointestinal resection, chronic diarrhea, and intestinal obstruction) may affect the oral absorption of anlotinib；
- Uncontrolled pleural, pericardial, or ascites requiring repeated drainage (investigator judgment); Severe bone injury caused by tumor bone metastasis may occur or occur after enrollment；
- Patients whose imaging (CT or MRI) showed that the tumor had invaded the important blood vessels or the investigators judged that the tumor was likely to invade the important blood vessels and cause fatal hemorrhage during the follow-up study；
- Unmitigated toxic effects higher than CTCAE grade 1 due to any previous antineoplastic therapy, excluding alopecia；
- Major surgical treatment, open biopsy, or significant traumatic injury within 28 days before the first dose；
- A wound or fracture that has not healed for a long time；
- Patients with a history of arterial/venous thrombosis/cancer thrombosis within 6 months before the first dose of drug, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism；
- People who have a history of psychotropic drug abuse and cannot abstain from it or have mental disorders；
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (61)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Fujian Cancer Hospital
Fuzhou, Fujian, 350014, China
First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510289, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, 510630, China
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008, China
Jiangmen Central Hospital
Jiangmen, Guangdong, 529030, China
Meizhou People's Hospital
Meizhou, Guangdong, 514031, China
Guigang City People's Hospital
Guigang, Guangxi, 537100, China
Nanxishan Hospital of Guangxi Zhuang Autonomous Region
Guilin, Guangxi, 541000, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545006, China
Liuzhou Municipal Liutie Central Hospital
Liuchow, Guangxi, 545007, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Hainan Ceneral Hospital
Haikou, Hainan, 570311, China
Tangshan People's Hospital
Tangshan, Hebei, 063000, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150081, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 450018, China
Nanyang first People's Hospital National Third Class A Hospital
Nanyang, Henan, 473000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052, China
Hubei Cancer Hospital
Wuhan, Hubei, 430079, China
Hunan Cancer Hospital
Changsha, Hunan, 410031, China
The Central Hospital Of Shaoyang
Shaoyang, Hunan, 422000, China
Inner Mongolia Autonomous Region People's Hospital
Hohhot, Inner Mongolia, 010017, China
Changchun Tumor Hospital
Changchun, Jilin, 130012, China
The first hospital of Jilin University
Changchun, Jilin, 130021, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110000, China
General Hospital Of Ningxia Medical University
Yinchuan, Ningxia, 750001, China
Qinghai Red Cross Hospital
Xining, Qinghai, 810000, China
The Second Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710038, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Shaanxi Provincial People's Hospital
Xi'an, Shaanxi, 712038, China
Binzhou Medical University Hospital
Binzhou, Shandong, 256600, China
Binzhou People's Hospital
Binzhou, Shandong, 256601, China
Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272001, China
Linyi Cancer Hospital
Linyi, Shandong, 276000, China
Weifang People's Hospital
Weifang, Shandong, 261000, China
Yidu Central Hospital Of Weifang
Weifang, Shandong, 262500, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Tengzhou Central People's Hospital
Zaozhuang, Shandong, 277500, China
Shanxi Cancer hospital
Taiyuan, Shanxi, 030000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 30000, China
Affiliated Cancer Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830054, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Maternal Health School of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315201, China
Beijing Obstetrics and Gynecology Hospital, Capital Medical University
Beijing, 100006, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, 100020, China
Chongqing University Cancer Hospital
Chongqing, 400032, China
The Southwest Hospital of Amu
Chongqing, 400038, China
Chongqing University Three Gorges Hospital
Chongqing, 400040, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, 400072, China
The Affiliated Hospital of Southwest Medical University
Chongqing, 646000, China
Fudan University Shanghai Cancer Center
Shanghai, 200032, China
Shanghai Tenth People's Hospital
Shanghai, 200040, China
Obstetrics & Gynecology Hospital of Fudan University
Shanghai, 200090, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, 300181, China
Tianjin Central Hospital of Gynecology Obstetrics
Tianjin, 300199, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2024
First Posted
June 26, 2024
Study Start
July 1, 2024
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
June 1, 2029
Last Updated
June 27, 2024
Record last verified: 2024-01