Efficacy and Safety of TQB2450 Injection Combined With Chemotherapy ± Anlotinib Hydrochloride Capsules for Advanced Endometrial Cancer or Sarcoma of Uterus.
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).
Timeline
- Start
- 2022-08-26
- Primary completion
- 2024-02-01
- Completion
- 2025-11-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benmelstobart | Monoclonal antibody | 1200 mg | — |
| Subject | Carboplatin | Small molecule | 5 unknown | — |
| Subject | Catequentinib | Small molecule | 8 mg | — |
| Subject | Catequentinib | Small molecule | 10 mg | — |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | — |
| Subject | Doxorubicin | Other / unclassified | 60 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 900 mg/m2 | — |
| Subject | Paclitaxel | Small molecule | 175 mg/m2 | — |