Actively Recruiting
Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors
Led by Second Affiliated Hospital of Soochow University · Updated on 2026-01-09
127
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to evaluate the effectiveness of PRaG-1 in improving CD8+ lymphocytopenia in patients with solid tumors who are tumor-free for more than six months after completing radiotherapy and/or chemotherapy. It will also assess the safety of PRaG-1 Cordycepin in these patients. The main questions it aims to answer are: Does PRaG-1 increase CD8+ lymphocyte counts by more than 25% in this patient population? Does the effect of PRaG-1 maintain when treatment is discontinued? What are the safety and tolerability profiles of PRaG-1 during and after the treatment period? Participants will receive open-label PRaG-1 (one tablet in the morning and one in the evening) for 14 days, and those who show a response (CD8+ lymphocytes increase by more than 25%) will enter a 14-day randomized withdrawal period, where they will be assigned to continue PRaG-1 or switch to a placebo. Throughout the study, participants will: Have their peripheral blood lymphocyte subpopulations tested at baseline and on Days 7 and 14 Undergo safety monitoring for adverse events according to CTCAE 5.0 criteria Provide information on their quality of life during the treatment period Researchers will compare the outcomes of those who continue PRaG-1 to those who receive a placebo to determine if the observed improvement in CD8+ lymphocytes is sustained, which would indicate that the drug is effective in maintaining immune response.
CONDITIONS
Official Title
Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of solid malignant tumors with confirmed pathology or medical history
- Tumor-free for more than six months after radiotherapy and/or chemotherapy
- Peripheral blood CD8+ absolute count below lower reference limit before 10:00 AM
- No immunomodulatory or immunosuppressive treatment within 2 weeks prior to enrollment
- ECOG performance status 0-1 with expected survival of at least 3 months
- AST and ALT less than or equal to 3 times upper limit of normal within 1 week prior
- Serum creatinine less than or equal to 2 times upper limit of normal
- Ability to understand the study and provide informed consent
You will not qualify if you...
- History of uncontrolled epilepsy, central nervous system disease, or mental disorders affecting consent or compliance
- Active significant cardiovascular disease including symptomatic coronary heart disease, NYHA class II or worse heart failure, serious arrhythmias needing medication, or myocardial infarction within past 12 months
- Active serious infections or major uncontrolled hematological, renal, metabolic, gastrointestinal, or endocrine disorders
- Allergy to fungi or components such as Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate
- History of immunodeficiency including HIV, acquired or congenital immunodeficiencies, organ transplantation, or long-term corticosteroid treatment
- Acute gout flare
- Any other condition judged unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
L
Liyuan Zhang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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