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)

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.

NCT Number	NCT06232083
Lead Sponsor	Anhui Provincial Hospital Collaborators: Akeso Pharmaceuticals, Inc.
Conditions	Lung Cancer, Esophageal Cancer, Cervical Cancer
Enrollment	20 participants
Start Date	2025-09-01
Primary Completion	2027-06-30 (estimated)
Study Completion	2027-09-01 (estimated)
Updated on ClinicalTrials.gov	2025-07-09