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.
‣ Patients must meet all the following criteria to be enrolled:
• The subjects voluntarily joined the study, signed informed consent, had good compliance and were willing to cooperate with the follow-up;
• There is no limit for men and women, ranging in age from 18 to 75 years old (including 18 and 75 years old);
• Pathologically confirmed esophageal cancer, lung cancer or cervical cancer;
• The expected survival time was more than 3 months;
• Recurrent or metastatic patients with previous treatment progress;
• ECoG 0-2 points;
• According to RECIST 1.1 standard, there was at least one extracranial measurable lesion;
• The laboratory test results within one week before enrollment meet the following conditions: 1) blood routine: HGB≥90g/L； WBC ≥ 4.0 × 109/L; Neut ≥ 2.0 × 109/l; PLT ≥ 100 × 109/l; 2) Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastasis); Bun and Cr ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 ml/min; 3) The results of echocardiography within two weeks before admission were consistent: left ventricular ejection fraction (LVEF)\>50%;
• The coagulation function was normal without active bleeding and thrombosis;
⁃ Patients without contraindications to radiotherapy;
⁃ The pregnancy test of patients of childbearing age was negative, and they voluntarily took effective and reliable contraceptive measures during the test;
⁃ Subjects who have received anti-tumor treatment in the past should not be enrolled until the toxicity of previous treatment has stabilized and returned to the baseline level (except for the residual hair loss effect) or the CTCAE V5.0 score ≤ 1.