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

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.61 sites in 1 country420 target enrollmentJuly 2024

ConditionsEndometrial Cancer

InterventionsAnlotinib hydrochloride capsule + TQB2450 injection Chemotherapy drug

DrugsAnlotinib hydrochloride capsule + TQB2450 injection Chemotherapy drug

Overview

Phase: Phase 3
Intervention: Anlotinib hydrochloride capsule + TQB2450 injection
Conditions: Endometrial Cancer
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Enrollment: 420
Locations: 61
Primary Endpoint: Progression-free survival (PFS) assessed by independent imaging review committee (IRC)
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

July 2024

End Date

June 2029

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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；

Exclusion Criteria

•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；

Arms & Interventions

Anlotinib hydrochloride capsules + TQB2450 injection

Anlotinib 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.

Intervention: Anlotinib hydrochloride capsule + TQB2450 injection

Chemotherapy drug

Based 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).

Intervention: Chemotherapy drug

Outcomes

Primary Outcomes

Progression-free survival (PFS) assessed by independent imaging review committee (IRC)

Time Frame: Up to 36 months after study start

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.

Secondary Outcomes

European Organization for Research on Treatment of Cancer Endometrial cancer Specific scale QLQ-EN24(Up to 96 weeks)
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)
Incidence of dose interruptions, dose reductions, and dose discontinuations due to study-drug-related toxicity during the trial(Up to 36 months after study start)
Duration of Response (DOR)(Up to 36 months after study start)
Incidence and severity of adverse event rate Adverse events (AE), serious adverse event (SAE)(Up to 36 months after study start)
Immunogenicity of TQB2450(Before administration (-15 minutes) in cycles 1, 2, 5, and 9, and 90 days after the last dose (±7days), each cycle is 21 days)
Disease control rate (DCR)(Up to 36 months after study start)
Incidence and severity of abnormal laboratory values(Up to 36 months after study start)
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)(Up to 96 weeks)
European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30)(Up to 96 weeks)