NCT05481645

Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.

Evaluating the Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for First-line Treatment of Patient With Advanced Endometrial Cancer or Sarcoma of Uterus: a Multi-center, Open-label, Randomized Controlled, Phase II Clinical Trial.

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 71 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical study plans to enroll 69 endometrial cancer patients and 5-10 uterine sarcoma patients. The trial is divided into a lead-in phase and a main phase. The lead-in phase will include 9 subjects, while the main phase will enroll 60 endometrial cancer patients randomized 1:1. Additionally, 5-10 uterine sarcoma patients will be enrolled. The study aims to evaluate the efficacy and safety of TQB2450 injection combined with chemotherapy ± anlotinib hydrochloride capsules as first-line treatment, followed by TQB2450 injection monotherapy ± anlotinib hydrochloride capsules as maintenance therapy for advanced endometrial cancer or uterine sarcoma. The study will also explore efficacy-related biomarkers, mechanisms of action, safety and/or pathological mechanisms, and surgical conversion rates. The primary endpoint is ORR (Objective Response Rate).

Conditions

• Advanced Endometrial Cancer
• Sarcoma of Uterus

Interventions

Type	Name	Description
DRUG	TQB2450 injection	TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents the binding of PD-L1 to PD-1 and B7.1 receptors on the surface of T cells, thereby reactivating T cells and enhancing the immune response.
DRUG	Anlotinib Hydrochloride Capsule	Anlotinib hydrochloride is a muti-target tyrosine kinase inhibitor.
DRUG	Carboplatin Injection	Carboplatin which s similar to alkylating agent, is a second-generation platinum anti-tumor drug, which mainly causes cross-linking of DNA within and between chains, destroys DNA molecules, and disintegrates the helix.
DRUG	Paclitaxel Injection	Paclitaxel is a diterpene alkaloid with anticancer activity
DRUG	Doxorubicin Hydrochloride Injection	Doxorubicin hydrochloride is a cycle non-specific anticancer chemotherapy drug, which directly acts on DNA, changes the nature of DNA template, and inhibits DNA polymerase.
DRUG	Gemcitabine Hydrochloride Injection	Gemcitabine is a cell cycle specific antimetabolic drug, which mainly acts on tumor cells at the DNA synthesis stage.
DRUG	Docetaxel injection	Docetaxel is an anti-tumor drug of paclitaxel, which plays an anti-tumor role by interfering with the microtubule network necessary for cell Mitosis and interphase cell function.

Timeline

• Start date: 2022-08-26
• Primary completion: 2024-02-01
• Completion: 2025-11-30
• First posted: 2022-08-01
• Last updated: 2026-01-09

Locations

11 sites across 1 country: China