NCT06475599

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
DRUG	Anlotinib hydrochloride capsule + TQB2450 injection	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.
DRUG	Chemotherapy drug	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.

Timeline

• Start date: 2024-07-01
• Primary completion: 2027-12-01
• Completion: 2029-06-01
• First posted: 2024-06-26
• Last updated: 2024-06-27

Locations

61 sites across 1 country: China