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)

Phase 1

Recruiting

• Conditions: Lung Cancer; Esophageal Cancer; Cervical Cancer

• Registration Number: NCT06232083
• Lead Sponsor: Anhui Provincial Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-16
• Study First Submitted QC: 2024-01-22
• Study First Posted: 2024-01-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-09
• Study Start: 2025-09-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
ORR	6 month post PLDR external irradiation	Objective response rate，The proportion of patients whose tumor volume shrinks by 30% and can be maintained for more than four weeks, which is the sum of complete remission and partial remission (CR+PR)

Secondary Outcome Measures

Name	Time	Method
TEAE	6 month post PLDR external irradiation	Treatment Emergent Adverse Event

Trial Locations

Locations (1)

The First Affiliated Hospital of University of Science and Technology of China; 🇨🇳 Hefei, British Columbia, China