Phase I Study of Cardunizumab Combined with Pulsed Low-dose Rate Radiation for Recurrent Lung, Esophageal, and Cervical Cancers

What this Trial Is About

This research aims to explore new treatment strategies for patients with recurrent lung cancer, esophageal cancer, or cervical cancer. These cancers often have limited treatment options after recurrence. Immune checkpoint inhibitors ICBs have shown promise but have insufficient response rates. Pulse low-dose rate radiotherapy PLDR is a newer technology that delivers radiation in pulses to increase tumor sensitivity while protecting the lymphatic system and reducing immune barriers. This study investigates whether combining PLDR with ICB can improve treatment outcomes for these recurrent cancers. The study evaluates a combination treatment of PLDR external irradiation and the immune checkpoint inhibitor cardunizumab. PLDR is delivered as 40 Gy over 20 fractions targeting the recurrent or metastatic lesions and nearby lymphatic areas. Cardunizumab is administered at 6 mgkg every two weeks during the PLDR treatment, then increased to 10 mgkg every three weeks as maintenance treatment for up to two years. This is an open-label, phase 1 clinical trial without masking or placebo control. Participants will undergo screening and regular assessments including imaging and laboratory tests to monitor tumor response and treatment safety. The primary outcome is the objective response rate measured six months after PLDR treatment. Secondary outcomes include treatment-emergent adverse events assessed at the same timepoint. Participants need to be followed for at least six months post-treatment, with ongoing monitoring for safety and efficacy. Researchers will also collect data on survival, quality of life, and side effects throughout the study period.

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)