NCT07002502Toborzás még nem indult2. fázis
Immune Modulation With PRaG-1 Treatment
Immune Modulation and Efficacy Assessment of PRaG-1 in Patients With Advanced Solid Malignancies: A Prospective, Multicenter, Open-Label Clinical Trial
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 10. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még
Rövid összefoglaló (regiszter, angolul)
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 enrollment. After enrollment, patients will receive oral administration of "PRaG-1" twice daily (morning and evening) for a total of 10 days. Peripheral blood lymphocyte tests will be performed before treatment, on day 5 post-treatment, and at the conclusion of treatment.
- Állapot (regiszter)
- Toborzás még nem indult
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 19 (tervezett)
- Első benyújtás
- 2025. máj. 25.
- Kezdés
- 2025. jún. 15.
- Elsődleges befejezés
- 2026. máj. 26.
- Fő szponzor
- Second Affiliated Hospital of Soochow University
- Betegségek
- Gyermekkori daganatok
- NCT-szám
- NCT07002502
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 19
- 2025. jún. 15. és az elsődleges befejezés (2026. máj. 26.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- 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.
Más betegség
- 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.
- 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.
Kiket keres a vizsgálat
- 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.
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