Actively Recruiting
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)
Led by Anhui Provincial Hospital · Updated on 2025-07-09
20
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
A
Anhui Provincial Hospital
Lead Sponsor
A
Akeso Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 to 75 years (including 18 and 75 years)
- Pathologically confirmed lung cancer, esophageal cancer, or cervical cancer
- Recurrent or metastatic disease with prior treatment progression
- Expected survival time of more than 3 months
- ECOG performance status of 0 to 2
- At least one measurable extracranial lesion per RECIST 1.1 criteria
- Laboratory tests within one week before enrollment meeting specified blood, liver, kidney, and heart function levels
- Normal coagulation function without active bleeding or thrombosis
- No contraindications to radiotherapy
- Negative pregnancy test for patients of childbearing potential and use of effective contraception during the study
- Previous anti-tumor treatment toxicity stabilized to baseline or CTCAE V5.0 score ≤1 except residual hair loss
You will not qualify if you...
- Patients with malignant tumors other than lung, esophageal, or cervical cancer
- Active malignant tumors within 5 years except cured locally curable tumors
- Participation in other drug clinical trials within 4 weeks before enrollment
- Radiotherapy to target area within 4 weeks before study entry
- Vaccination with live attenuated vaccine within 4 weeks before or during study
- Arteriovenous thrombosis events within 6 months
- Receiving other anti-tumor treatments simultaneously
- History of allergy to study drug components or radiation hypersensitivity
- Active infectious diseases
- Severe or uncontrolled diseases
- Pregnant or lactating females, or positive pregnancy test
- Severe concomitant diseases threatening safety or study completion
- History of neurological or mental disorders affecting cooperation
- History of allogeneic organ or hematopoietic stem cell transplantation
- Immune deficiency or ongoing immunosuppressive therapy with active autoimmune diseases except stable conditions
- Active inflammatory bowel disease or gastrointestinal obstruction requiring special treatments
- Symptomatic CNS metastasis or spinal cord compression unless clinically stable
- Recurrent effusions needing repeated drainage or local treatment
- Specific cardiovascular diseases including recent myocardial infarction, severe heart failure, severe arrhythmias, or prolonged QT interval
- Investigator judgment of unsuitability for other reasons
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of University of Science and Technology of China
Hefei, British Columbia, China, 230001
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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