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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
420
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.
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.
Time frame: Up to 36 months after study start
Overall survival (OS)
Time from randomization to death from any cause.
Time frame: Up to 36 months after study start
Progression-free survival (PFS) assessed by investigators
Time from subject randomization (first treatment) to first disease progression or death from any cause, whichever occurred first, was assessed by the investigator according to RECIST 1.1.
Time frame: Up to 36 months after study start
Objective mitigation rate (ORR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements, namely the proportion of patients with complete response (CR) and partial response (PR).
Time frame: Up to 36 months after study start
Duration of Response (DOR)
From the time of tumor first evaluated as complete or partial response to the time of first disease progression or death from various causes,if the tumor remission is not confirmed, it can not be used.
Time frame: Up to 36 months after study start
Disease control rate (DCR)
According to RECIST 1.1 criteria, proportion of patients with confirmed tumor volume reduction to pre-specified values and maintained minimum requirements, namely the proportion of patients with CR,PR and stable disease (SD).
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Anhui Provincial Hospital
Hefei, Anhui, China
Fujian Cancer Hospital
Fuzhou, Fujian, China
First Hospital of Lanzhou University
Lanzhou, Gansu, China
Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
The First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China
Huizhou Central People's Hospital
Huizhou, Guangdong, China
Jiangmen Central Hospital
Jiangmen, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Guigang City People's Hospital
Guigang, Guangxi, China
...and 51 more locations
Time frame: Up to 36 months after study start
Incidence and severity of abnormal laboratory values
Incidence and severity of laboratory inspection indicators exceed the normal range
Time frame: Up to 36 months after study start
Incidence and severity of adverse event rate Adverse events (AE), serious adverse event (SAE)
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs)
Time frame: Up to 36 months after study start
Incidence of dose interruptions, dose reductions, and dose discontinuations due to study-drug-related toxicity during the trial
Incidence of dose interruptions, dose reductions, and dose discontinuations due to study-drug-related toxicity during the trial
Time frame: Up to 36 months after study start
Immunogenicity of TQB2450
Incidence of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs)
Time frame: Before administration (-15 minutes) in cycles 1, 2, 5, and 9, and 90 days after the last dose (±7days), each cycle is 21 days
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)
Questionnaire: EORTC Quality of Life Questionnaire (QLQ-C30):For questions 1 to 28, choose a number from 1 to 4, 1 means none and 4 means very good. For questions 29 and 30, choose a number from 1 to 7, with 1 being very poor and 7 being very good.
Time frame: Up to 96 weeks
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Questionnaire: European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) : The scale has numbers from 0 to 100. 100 represents the best health imaginable. 0 is the worst health imaginable.
Time frame: Up to 96 weeks
European Organization for Research on Treatment of Cancer Endometrial cancer Specific scale QLQ-EN24
Questionnaire: European Organization for Research on Treatment of Cancer Quality of Life questionnaire 24 (QLQ-EN24):From questions 1 to 24, choose a number from 1 to 4, where 1 means none and 4 means very much.
Time frame: Up to 96 weeks