NCT07092696

Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Cervical Cancer

Induction Immunotherapy Combined With Chemotherapy Followed by Concurrent Chemoradiotherap and Immunotherapy for Advanced Cervical Cancer: An Open-Label, Single-Arm, Phase II Trial

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (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 tolerability of a platinum-based regimen combined with the PD-1 antibody toripalimab administered prior to concurrent chemoradiotherapy in patients with locally advanced cervical cancer.

Detailed description

At the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, investigators reported that neoadjuvant camrelizumab combined with induction chemotherapy, followed by camrelizumab plus concurrent chemoradiotherapy and subsequent camrelizumab maintenance, achieved an overall response rate of 100 % in patients with locally advanced cervical cancer, with an acceptable safety profile. Pre-clinical studies have suggested that concurrent chemoradiotherapy may dampen immune activation in cervical cancer, including reductions in the CD4+/CD8+ T-cell ratio and decreased T-cell receptor (TCR) diversity. These findings imply that administration of immunotherapy prior to chemoradiotherapy might be more effective than giving it concomitantly or afterwards. Informed by these clinical and translational data, we propose to conduct an initial, prospective phase II trial to evaluate the efficacy and safety of neoadjuvant chemo-immunotherapy followed by concurrent chemoradiotherapy plus immunotherapy in patients with locally advanced cervical cancer, thereby laying the groundwork for a subsequent phase III investigation.

Conditions

• Cervical Cancer

Interventions

Type	Name	Description
DRUG	Toripalimab	Induction chemo-immunotherapy (platinum-based tri-weekly regimen) * Paclitaxel 175 mg/m² IV on day 1 * Cisplatin 50 mg/m² IV on day 1 or carboplatin AUC 4-5 IV on day 1 * Toripalimab 240 mg IV on day 1, administered immediately before each chemotherapy infusion Cycle length: every 3 weeks Number of cycles: 2 Concurrent chemoradiotherapy (weekly regimen) * Radiation therapy delivered according to institutional protocol * Cisplatin 40 mg/m² IV once weekly * Toripalimab 240 mg IV on day 1 of every 3-week cycle, given before chemotherapy Cycle length: every 3 weeks during radiotherapy Maintenance immunotherapy • Toripalimab 240 mg IV on day 1 every 3 weeks (Q3W) Duration: 1 year (total 13 cycles)
RADIATION	Pelvic External-Beam Radiotherapy (EBRT)	* PTV: 6 MV photons, 1.80 Gy per fraction × 28 fractions = 50.4 Gy. * PGTVnd: 6 MV photons, 2.14 Gy per fraction × 28 fractions = 59.92 Gy. Brachytherapy:Dose prescriptions * Dose: 7.00 Gy per fraction × 4 fractions = 28.0 Gy.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-12-01
• Completion: 2028-12-01
• First posted: 2025-07-30
• Last updated: 2025-07-30

Locations

1 site across 1 country: China