NCT05084677

Toripalimab Combined With Concurrent Chemoradiotherapy in Cervical Cancer

Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy in Patients With Locally Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Tianjin Medical University Cancer Institute and Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent platinum-based chemoradiotherapy in patients with locally advanced cervical cancer.

Detailed description

Up to now, there have been several prospective studies exploring the effectiveness of PD-1 inhibitors in patients with recurrent/ metastatic cervical cancer. The results showed that the overall objective response rate (ORR) was between 12.2% and 55.6%, and pembrolizumab was approved by the US Food and Drug Administration for patients with advanced PD-L1-positive cervical cancer who experienced progression during or after chemotherapy. However, the evidence of using PD-1 inhibitors together with concurrent chemotheradiotherapy in patients with locally advanced cervical cancer is rare, so we initiated this single arm prospective phase II clinical study. The purpose is to explore the efficacy and tolerance of adding toripalimab simultaneously and subsequently to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Toripalimab Combined With Concurrent Platinum-based Chemoradiotherapy	Toripalimab 240mg intravenously(IV) every 3 weeks (Q3W) concurrent with chemoradiotherapy; 6 cycles of Toripalimab 240mg intravenously(IV) every 3 weeks (Q3W) after chemoradiotherapy; Toripalimab 240mg intravenously(IV) every 6 weeks (Q6W) thereafter until the whole treatment period reached one year since the beginning.

Timeline

• Start date: 2021-01-01
• Primary completion: 2022-12-31
• Completion: 2024-12-31
• First posted: 2021-10-20
• Last updated: 2024-01-18

Locations

1 site across 1 country: China