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NOT YET RECRUITING

NCT07267234

PHASE2

PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)

Sponsor: Second Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if a combination treatment using PRaG-1 Cordycepin Tablets with radiation therapy, immune-boosting injections, and immunotherapy drugs can help patients with advanced solid tumors. It will also assess safety. The main questions it aims to answer are: Does this treatment improve immune function and slow tumor growth? What side effects or risks occur during treatment? Participants will: Take PRaG-1 Cordycepin Tablets (a natural compound derived from Cordyceps fungus) orally: higher dose for 7 days before radiation, then lower daily dose for 2 weeks Receive targeted radiation therapy to the tumor area (5-12 Gy total in 2-3 sessions) Get daily immune-boosting injections (GM-CSF) for 7 days starting with radiation Receive immunotherapy drugs (PD-1/PD-L1 inhibitors) within one week after radiation Have blood drawn and small tumor tissue samples taken before and after the first two treatment cycles for immune analysis All participants will receive this combination treatment; there is no placebo or alternative treatment group in this study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-12-01

Completion Date

2027-09-01

Last Updated

2025-12-05

Healthy Volunteers

Conditions

Solid Cancer Lymphopenia Radiotherapy Immune Checkpoint Inhibitor

Interventions

DRUG

PD -1/PD-L1 monoclonal antibody

PRaG-1 Cordycepin Tablets+ Radiotherapy+ GM-CSF+ PD-1/PD-L1 inhibitors

Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed treatment-naïve or relapsed/metastatic advanced solid malignancies with no standard treatment option per current clinical guidelines or intolerance to standard therapy; measurable metastatic lesions ≥1 cm (by RECIST criteria); absolute lymphocyte count (ALC) below lower limit of normal (LLN). 3. No history of congestive heart failure, unstable angina, or unstable cardiac arrhythmias within the past 6 months. 4. ECOG performance status 0-3; estimated life expectancy ≥3 months. 5. No history of significant hematologic, cardiac, pulmonary, hepatic, or renal dysfunction. 6. Baseline AST ≤3×ULN and ALT ≤3×ULN (≤5×ULN for hepatocellular carcinoma or liver metastases); creatinine ≤3×ULN. 7. Capacity to comprehend study procedures and voluntarily provide written informed consent. Exclusion Criteria: 1. History of other malignancies within the past 5 years, except for adequately treated non-melanoma skin cancer or cervical carcinoma in situ. 2. Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that, in the investigator's judgment, may interfere with informed consent or treatment adherence. 3. Clinically significant active cardiac disease, including symptomatic coronary artery disease, NYHA Class II or higher congestive heart failure, severe arrhythmias requiring pharmacological intervention, or myocardial infarction within the past 12 months. 4. History of solid organ transplant requiring ongoing immunosuppressive therapy. 5. Known significant active infection, or significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious uncontrolled comorbidities as determined by the investigator. 6. Allergy to any component of the study drug(s). 7. History of immunodeficiency, including HIV infection, acquired or congenital immunodeficiency disorders, solid organ transplant, or chronic immunosuppressive therapy for immune-related conditions. 8. Active or latent tuberculosis infection confirmed by positive T-SPOT.TB test or chest X-ray findings suggestive of tuberculosis. 9. Any other condition that, in the investigator's clinical judgment, may compromise study participation or safety.