Status:
NOT_YET_RECRUITING
Immune Modulation With PRaG-1 Treatment
Lead Sponsor:
Second Affiliated Hospital of Soochow University
Conditions:
Cancer
Solid Cancer
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
The study is a single-center, prospective, single-arm, Phase II clinical trial. Eligible patients with advanced solid malignant tumors will sign the informed consent form and undergo screening for enr...
Detailed Description
The "PRaG-1" cordycepin tablet involved in this clinical study is produced by Shengmingyuan Company, a subsidiary of the National Biochemical Engineering Research Center at Nanjing Tech University. It...
Eligibility Criteria
Inclusion
- Patients with a history of other malignant diseases within the past 5 years, except for curatively treated skin cancer and cervical carcinoma in situ; Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, which, in the judgment of the investigator, may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment; Clinically significant (i.e., active) cardiovascular disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months; Patients currently receiving immunosuppressive therapy; Known active major infections, or significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator; Patients with hypersensitivity to any component of the investigational drugs; History of immunodeficiency, including positive HIV test results or other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy; Other conditions deemed unsuitable for enrollment by the investigator.
Exclusion
- Patients with a history of any other malignant diseases within the past 5 years are excluded, except for curatively treated skin cancer and cervical carcinoma in situ.
- Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders are excluded if, in the judgment of the investigator, these conditions may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment.
- Clinically significant (active) cardiovascular disease is excluded, including symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.
- Patients currently receiving immunosuppressive therapy are excluded. Known active major infections are excluded, as are significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator.
- Patients with hypersensitivity to any component of the investigational drugs are excluded.
- History of immunodeficiency is excluded, including positive HIV test results, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy.
- Other conditions deemed unsuitable for enrollment by the investigator are excluded.
Key Trial Info
Start Date :
June 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 26 2026
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT07002502
Start Date
June 15 2025
End Date
June 26 2026
Last Update
June 10 2025
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