NCT06232083

A Multi Tumor, Open Phase I Clinical Study on the Progression of First-line Anti-tumor Therapy Using Cardonizumab Combined With Pulsed Low-dose Rate External Irradiation (PLDR)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Anhui Provincial Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

At present, the treatment methods for recurrent cancers are very limited. The immune checkpoint inhibitors (ICBs) is a promising new directions for recurrent lung cancer/ esophageal cancer / cervical cancer, but the clinical response rate is insufficient. Pulse low-dose rate radiotherapy (PLDR) is a new technology in recent years, which uses continuous pulse low-dose rate irradiation to induce hypersensitivity in tumors, and its clinical safety has been verified. Compared to conventional radiotherapy, PLDR has advantages in protecting the lymphatic system and relieving the immune barrier, but it is still unclear whether it can improve the efficacy of ICB. This project aims to combine PLDR with ICB to explore new strategies for recurrent patients.

Conditions

• Lung Cancer
• Esophageal Cancer
• Cervical Cancer

Interventions

Type	Name	Description
RADIATION	PLDR+Cardunizumab	Application of PLDR external irradiation combined with Cardunizumab in recurrent lung cancer, esophageal cancer and cervical cancer.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-06-30
• Completion: 2027-09-01
• First posted: 2024-01-30
• Last updated: 2025-07-09

Locations

1 site across 1 country: China