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OncoMatch/Clinical Trials/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)

Is NCT06232083 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies non-drug interventions for lung cancer.

Phase 1RecruitingAnhui Provincial HospitalNCT06232083Data as of May 2026

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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Esophageal Carcinoma

Cervical Cancer

Disease stage

Metastatic disease required

Recurrent or metastatic patients with previous treatment progress; According to RECIST 1.1 standard, there was at least one extracranial measurable lesion

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: anti-tumor treatment

Recurrent or metastatic patients with previous treatment progress

Cannot have received: other anti-tumor treatment (concurrent)

Receiving any other anti-tumor treatment at the same time

Cannot have received: investigational drug

Patients who had participated in clinical trials of other drugs within 4 weeks before enrollment

Cannot have received: radiotherapy

who had received radiotherapy for the target area within 4 weeks before entering this study

Lab requirements

Blood counts

HGB≥90g/L; WBC ≥ 4.0 × 10^9/L; Neut ≥ 2.0 × 10^9/l; PLT ≥ 100 × 10^9/l

Kidney function

Bun and Cr ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 ml/min

Liver function

TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastasis)

Cardiac function

LVEF >50% by echocardiography; exclusion for NYHA III-IV heart failure, severe arrhythmias, QTCF >470 ms, recent MI/angina/ischemia/thrombosis

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%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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