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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
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).
Details
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 3 |
| Status | NOT_YET_RECRUITING |
| Enrolment | 420 |
| Start date | 2024-07 |
| Completion | 2029-06 |
Conditions
- Endometrial Cancer
Interventions
- Anlotinib hydrochloride capsule + TQB2450 injection
- Chemotherapy drug
Primary outcomes
- Progression-free survival (PFS) assessed by independent imaging review committee (IRC) — 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.
Countries
China