Efficacy and Safety of TQB2450 Combined With Chemotherapy ± Anlotinib for Advanced Endometrial Cancer
Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
Summary
This study plans to enroll 69 subjects. The experimental set is divided into lead-in trial
and formal trial. The lead-in trial includes 9 subjects to observe the safety of the
combination and the dosage of anlotinib dihydrochloride capsules before the formal test. In
the first-line treatment stage, TQB2450 injection 1200mg, d1/Q3W+ anlotinib hydrochloride
capsules 8mg/qd, d8-21/Q3W+carboplatin injection AUC= 5mg/ml.min, d1/Q3W+paclitaxel injection
175mg/m2, d1 /Q3W Treat for 6-8 cycles, collect safety information. If the toxicity is
tolerable, TQB2450 injection 1200mg, d1/Q3W + Anlotinib hydrochloride capsules 10mg/qd,
d8-21/Q3W treatment in the maintenance phase. If the toxicity is intolerable, the dose of
anlotinib hydrochloride capsules is reduced to 6 mg/qd, d8-21/Q3W. During the maintenance
phase, safety information will continue to be collected to determine the specific dosage of
anlotinib hydrochloride capsules in the formal trial.
The formal trial includes 60 subjects. The randomization is 1:1. Test group one: First-line
treatment stage: TQB2450 injection 1200mg, d1/Q3W + carboplatin injection AUC=5 mg/ml.min,
d1/Q3W+paclitaxel injection 175mg/m2, d1/Q3W; 6-8 cycles; Maintenance phase: TQB2450
injection 1200mg, d1/Q3W. Test group two:First-line treatment stage: TQB2450 injection
1200mg, d1/Q3W+anlotinib hydrochloride capsules 8mg/qd, d8-21/Q3W+carboplatin injection AUC=5
mg/ml.min, d1/Q3W+paclitaxel injection 175mg/m2 , d1/Q3W; 6-8 cycles; Maintenance phase:
TQB2450 injection 1200mg, d1/Q3W + Anlotinib hydrochloride capsules 10mg/qd, d8-21/Q3W The
purpose is to evaluate efficacy and safety of TQB2450 injection combined with chemotherapy ±
anlotinib hydrochloride capsules for first-line treatment and maintenance treatment of
patient with advanced endometrial cancer, and explore biomarkers related to efficacy,
mechanism of action, safety and/or pathological mechanisms. ORR is the primary endpoint.