Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-01-18 @ 2:06 AM
Study NCT ID:
NCT07267234
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-05
First Post:
2025-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)
Sponsor:
Second Affiliated Hospital of Soochow University
Organization:
Study Overview
Official Title:
PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
1. This clinical study utilizes PRaG-1 Cordycepin Tablets (oral administration) to modulate immune cell and cytokine profiles. Lymphocyte subset analysis is performed before and after treatment to quantify immune function changes.
2. Treatment phases:
Cordycepin: PRaG-1 Cordycepin Tablets (manufactured by Life Origin Biotechnology Co., Ltd., affiliated with the National Bioengineering Engineering Technology Center, Nanjing Tech University) contain 200 mg cordycepin per tablet and hold National Food Production License No. SC11332019200201.
Loading dose: Initiated 1 week prior to radiotherapy, administered as 2 tablets once daily after meals with water for 7 consecutive days.
Maintenance dose: Following loading dose completion, 1 tablet once daily after meals with water is continued starting with radiotherapy for 2 weeks per cycle (every 3 weeks). Efficacy is assessed at each cycle.
Biospecimen collection: 5 mL blood and 2 g tumor biopsy tissue are obtained before and after the first two treatment cycles for immune function analysis (including bulk RNA sequencing, single-cell sequencing, TCR sequencing, proteomic analysis, metabolomic analysis, gut microbiome analysis, and urinary extracellular vesicle analysis).
Treatment discontinuation criteria: Confirmed disease progression, intolerable toxicity, withdrawal of informed consent, death, or other protocol-specified criteria.
Radiotherapy: Begins on Day 1 of the treatment cycle; 5-12 Gy total dose delivered in 2-3 fractions per lesion, once daily.
GM-CSF: 200 μg subcutaneously daily starting on radiotherapy day, continued for 7 days.
Immunotherapy: PD-1/PD-L1 inhibitors initiated within one week post-radiotherapy.
3. Maintenance phases:
Stage A: ≥2 cycles of cordycepin combined with radiotherapy, PD-1/PD-L1 inhibitors, and GM-CSF.
Stage B: Maintenance therapy with PD-1/PD-L1 inhibitors, GM-CSF, and cordycepin for ≥6 months.
Stage C: Continued PD-1/PD-L1 inhibitor monotherapy until disease progression or unacceptable toxicity.
2. Treatment phases:
Cordycepin: PRaG-1 Cordycepin Tablets (manufactured by Life Origin Biotechnology Co., Ltd., affiliated with the National Bioengineering Engineering Technology Center, Nanjing Tech University) contain 200 mg cordycepin per tablet and hold National Food Production License No. SC11332019200201.
Loading dose: Initiated 1 week prior to radiotherapy, administered as 2 tablets once daily after meals with water for 7 consecutive days.
Maintenance dose: Following loading dose completion, 1 tablet once daily after meals with water is continued starting with radiotherapy for 2 weeks per cycle (every 3 weeks). Efficacy is assessed at each cycle.
Biospecimen collection: 5 mL blood and 2 g tumor biopsy tissue are obtained before and after the first two treatment cycles for immune function analysis (including bulk RNA sequencing, single-cell sequencing, TCR sequencing, proteomic analysis, metabolomic analysis, gut microbiome analysis, and urinary extracellular vesicle analysis).
Treatment discontinuation criteria: Confirmed disease progression, intolerable toxicity, withdrawal of informed consent, death, or other protocol-specified criteria.
Radiotherapy: Begins on Day 1 of the treatment cycle; 5-12 Gy total dose delivered in 2-3 fractions per lesion, once daily.
GM-CSF: 200 μg subcutaneously daily starting on radiotherapy day, continued for 7 days.
Immunotherapy: PD-1/PD-L1 inhibitors initiated within one week post-radiotherapy.
3. Maintenance phases:
Stage A: ≥2 cycles of cordycepin combined with radiotherapy, PD-1/PD-L1 inhibitors, and GM-CSF.
Stage B: Maintenance therapy with PD-1/PD-L1 inhibitors, GM-CSF, and cordycepin for ≥6 months.
Stage C: Continued PD-1/PD-L1 inhibitor monotherapy until disease progression or unacceptable toxicity.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: