Cordycepin (PRaG-1) to raise CD8+ T‑cell counts after treatment for solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with solid tumors who have been tumor‑free for at least six months and have low CD8+ counts first receive open‑label PRaG‑1 (one tablet morning and evening) for 14 days. Participants whose CD8+ counts increase by more than 25% are defined as responders and enter a 14‑day randomized withdrawal phase to either continue PRaG‑1 or switch to placebo. The study uses a two‑stage sequential design with Pocock alpha allocation to decide whether to stop after the first stage or proceed to a second stage. Safety and tolerability are monitored throughout with serial peripheral blood lymphocyte subpopulation testing and standard laboratory assessments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years;
2. Participants with solid malignant tumors, with confirmed pathological diagnosis or medical history; they have completed radiotherapy and/or chemotherapy more than six months ago; and peripheral blood CD8+ absolute count (blood drawn before 10:00 AM) below the lower reference limit (LRL);
3. No treatment with immunomodulatory or immunosuppressive agents within the past 2 weeks prior to enrollment;
4. ECOG performance status score of 0-1, with an estimated life expectancy of ≥ 3 months;
5. AST and ALT ≤ 3.0 times the upper limit of normal (ULN) within one week prior to study enrollment; serum creatinine ≤ 2 times ULN;
6. Ability to understand the study and voluntarily provide written informed consent.

Exclusion Criteria:

1. History of uncontrolled epilepsy, central nervous system (CNS) disease, or mental disorders, as determined by the investigator to be clinically significant and potentially interfere with the participant's ability to provide informed consent or comply with medication;
2. Significant (i.e., active) cardiovascular disease, including symptomatic coronary heart disease, congestive heart failure classified as New York Heart Association (NYHA) Class II or worse, or serious arrhythmias requiring pharmacological intervention, or history of myocardial infarction within the past 12 months;
3. Known active serious infections, or in the investigator's opinion, presence of major hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious, uncontrolled comorbidities;
4. History of allergy to fungi, or to any of the following components: Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate;
5. History of immunodeficiency, including HIV positive status, or diagnosis with other acquired or congenital immunodeficiencies, or a history of organ transplantation, or immunological disorders requiring long-term oral corticosteroid treatment;
6. Acute gout flare
7. Any other condition deemed unsuitable for enrollment by the investigator.

Where it's running

• The Second Affiliated Hospital of Soochow University
  Suzhou, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Liyuan Zhang, Doctor
• Email: zhangliyuan126@126.com
• Phone: 0512-67784829

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.