Actively Recruiting
A Multi Tumor, Open Phase I Study on First-line Anti-tumor Therapy Using Cardunizumab Combined With Pulsed Low-dose Rate External Irradiation
Led by Anhui Provincial Hospital · Updated on 2025-07-09
20
Participants Needed
1
Research Sites
9 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
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 mg/kg every two weeks during the PLDR treatment, then increased to 10 mg/kg 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.
CONDITIONS
Brief 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...
- Participants must voluntarily join the study, sign informed consent, and agree to follow-up
- Men and women aged 18 to 75 years
- Pathologically confirmed diagnosis of esophageal cancer, lung cancer, or cervical cancer
- Expected survival time greater than 3 months
- Recurrent or metastatic disease after prior treatment progression
- Eastern Cooperative Oncology Group (ECoG) performance status of 0 to 2
- At least one measurable extracranial lesion by RECIST 1.1 criteria
- Laboratory tests within one week prior meeting specified blood count and biochemistry levels
- Normal coagulation function without active bleeding or thrombosis
- No contraindications to radiotherapy
- Negative pregnancy test for women of childbearing potential and use of effective contraception
- Previous anti-tumor treatment toxicity resolved to baseline or CTCAE V5.0 score ≤ 1 except hair loss
You will not qualify if you...
- Malignant tumors other than esophageal, lung, or cervical cancer
- Other active malignant tumors within 5 years except certain cured local tumors
- Participation in other drug clinical trials within 4 weeks or recent radiotherapy/vaccination within 4 weeks
- Arteriovenous thrombosis events within 6 months
- Receiving other anti-tumor treatments concurrently
- History of allergy to study drug components or radiation hypersensitivity
- Active infections or severe uncontrolled diseases
- Pregnancy, lactation, or positive pregnancy test
- Serious concomitant diseases affecting safety or study completion
- Neurological or mental disorders preventing cooperation
- History of organ or stem cell transplantation
- Immune deficiency or ongoing immunosuppressive therapy with active autoimmune diseases except stable conditions
- Active inflammatory bowel disease or gastrointestinal conditions requiring specialized care
- Symptomatic CNS metastases or spinal cord compression unless stable and off steroids/anticonvulsants for 2 weeks
- Uncontrolled third space effusions requiring repeated drainage
- Significant cardiovascular diseases including recent myocardial infarction, severe heart failure, arrhythmias, or prolonged QT interval
- Investigator judgment deeming unsuitability for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years
Participants receive first-line anti-tumor therapy combining Cardunizumab with Pulsed Low-dose Rate External Irradiation (PLDR). Cardunizumab is administered during and after PLDR external irradiation with maintenance treatment for up to 2 years.
Multiple visits during 20 fractions of PLDR external irradiation and regular follow-up visits during maintenance treatment
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here