NCT06416696

Toripalimab for High-risk Locally Advanced Cervical Cancer

Toripalimab Combined With Chemoradiotherapy Followed by Toripalimab Maintenance Therapy for High-risk Locally Advanced Cervical Cancer: the Phase II Single-arm TorCH -CC Study

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 57 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical study assesses the efficacy and safety of Toripalimab combined with chemoradiotherapy (CRT) followed by Toripalimab maintenance in treating high-risk locally advanced cervical cancer (HR-LACC). Despite CRT being the standard treatment, HR-LACC patients face poor survival outcomes. Toripalimab, a cost-effective PD-1 inhibitor, has shown promise in prior research. The primary endpoint is 2-year progression-free survival, with the study aiming to improve treatment accessibility and patient prognoses in China.

Detailed description

Cervical cancer is the most prevalent malignant tumor of the female reproductive system in China, with an estimated 150,700 new cases and 55,700 new deaths annually. Concurrent chemoradiotherapy (CRT) remains the standard treatment for locally advanced cervical cancer (LACC). However, for high-risk LACC (HR-LACC) patients, the 2-year progression-free survival (PFS) rate is only 57%-62%, and the 5-year overall survival (OS) rate is 52%-64%, which are the leading causes of patient mortality. The KEYNOTE-A18 study demonstrated that the combination of pembrolizumab and CRT reduced the progression risk and death risk by 30% and 27%, respectively, for HR-LACC patients. Following this, the FDA approved pembrolizumab in combination with CRT for the treatment of newly diagnosed stages III-IVA cervical cancer in January 2024. Nevertheless, the high cost of pembrolizumab poses a significant barrier for patients in China. Toripalimab, the first domestically approved PD-1 inhibitor in China, has shown good safety and efficacy in previous studies and is more affordable. This phase II, single-arm, open-label study aims to evaluate the efficacy and safety of Toripalimab combined with CRT followed by Toripalimab maintenance therapy in 130 patients with stages III-IVA cervical cancer. The primary endpoint is the 2-year PFS. The study is expected to contribute to the implementation of precision and personalized treatment for HR-LACC in China, with the potential to improve patient survival rates and quality of life.

Conditions

• Cervical Cancers

Interventions

Type	Name	Description
DRUG	Toripalimab	1. Radiotherapy: Both external beam and brachytherapy, with radiation therapy techniques, target delineation, prescribed doses, and organ-at-risk constraints following established guidelines. 2. Chemotherapy: The preferred regimen is cisplatin at a dose of 40mg/m\^2 administered intravenously once weekly for 5-6 cycles; for patients intolerant to cisplatin or with renal impairment, carboplatin (AUC=2) may be considered, also administered once weekly. 3. Toripalimab concurrent immunotherapy: Following the regimens of phase III RCTs such as JUPITER-02, JUPITER-06, CHOICE-01, NEOTORCH, and RENOTORCH, Toripalimab is administered at a fixed dose of 240mg per infusion, given intravenously once every 3 weeks for three doses. 4. The concurrent chemoradiotherapy and immunotherapy phase does not exceed 8 weeks in duration.

Timeline

• Start date: 2024-01-09
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-05-16
• Last updated: 2026-01-02

Locations

1 site across 1 country: China