Actively Recruiting
Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors: A Randomized Withdrawal Trial
Led by Second Affiliated Hospital of Soochow University · Updated on 2026-01-09
127
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial evaluates the effects of PRaG-1, a cordycepin tablet, on improving CD8+ lymphocytopenia in patients with solid tumors who have been tumor-free for over six months after completing radiotherapy or chemotherapy. The study aims to determine whether PRaG-1 increases CD8+ lymphocyte counts by more than 25%, whether this effect persists after stopping treatment, and to assess the safety and tolerability of PRaG-1 in this population. Participants will take PRaG-1 orally, one tablet in the morning and one in the evening, for 14 days during an open-label phase. Those who respond with a CD8+ lymphocyte increase over 25% will enter a 14-day randomized withdrawal phase where they will either continue PRaG-1 or switch to a placebo. Lymphocyte counts will be measured at baseline, and on days 7, 14, 21, and 28. Safety is monitored throughout and adverse events are recorded. Throughout the study, participants will have blood tests to measure lymphocyte levels, and their quality of life will be assessed. Safety monitoring follows established criteria for adverse events. Researchers will compare the immune response between those continuing treatment and those on placebo after withdrawal to determine if PRaG-1 maintains increased lymphocyte counts. The trial is expected to run until September 2026.
CONDITIONS
Brief 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
- Diagnosed with solid malignant tumors with confirmed pathology or medical history
- Completed radiotherapy and/or chemotherapy more than six months ago
- Peripheral blood CD8+ absolute count below the lower reference limit
- No treatment with immunomodulatory or immunosuppressive agents within 2 weeks before enrollment
- ECOG performance status score of 0-1 with estimated life expectancy of at least 3 months
- AST and ALT levels no more than 3 times the upper limit of normal within one week before enrollment
- Serum creatinine no more than 2 times the upper limit of normal
- Ability to understand the study and provide written informed consent
You will not qualify if you...
- History of uncontrolled epilepsy, central nervous system disease, or mental disorders interfering with consent or medication compliance
- Active significant cardiovascular disease, including symptomatic coronary heart disease, congestive heart failure NYHA Class II or worse, serious arrhythmias needing medication, or recent myocardial infarction within 12 months
- Known active serious infections or major uncontrolled hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction
- Allergy to fungi or any components of the study drug including Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate
- History of immunodeficiency such as HIV positive status, organ transplantation, or long-term corticosteroid treatment
- Acute gout flare
- Any other condition deemed unsuitable for enrollment by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 14 days
Participants receive open-label PRaG-1 tablets, one in the morning and one in the evening, for 14 days.
1 baseline visit and 4 treatment visits on Days 7, 14, 21, and 28
Duration - 14 days
Participants who respond to the run-in period by increasing CD8+ lymphocytes by more than 25% enter a randomized withdrawal phase receiving either PRaG-1 or placebo tablets twice daily for 14 days.
Twice daily medication with visits on Days 21 and 28 for assessment
Duration - 4 weeks
Participants are monitored for adverse events and safety for four weeks after treatment ends.
Periodic safety assessments during follow-up
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
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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