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

NCT07267234 | Not Yet Recruiting Phase 2

• 1 other identifier: JD-LK2025017-IR01
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Cancer; Lymphopenia; Radiotherapy; Immune Checkpoint Inhibitor

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate #ORR#

  Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

  36 months

Secondary Outcomes (3)

• Disease control rate (DCR)

  36 months

• Progression-free Survival (PFS)

  36 months

• Adverse event

  36 months

Study Arms (1)

treatment

EXPERIMENTAL

Drug: PD -1/PD-L1 monoclonal antibody

Interventions

PD -1/PD-L1 monoclonal antibody DRUG

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

treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• 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).
• No history of congestive heart failure, unstable angina, or unstable cardiac arrhythmias within the past 6 months.
• ECOG performance status 0-3; estimated life expectancy ≥3 months.
• No history of significant hematologic, cardiac, pulmonary, hepatic, or renal dysfunction.
• Baseline AST ≤3×ULN and ALT ≤3×ULN (≤5×ULN for hepatocellular carcinoma or liver metastases); creatinine ≤3×ULN.
• Capacity to comprehend study procedures and voluntarily provide written informed consent.

You may not qualify if:

• History of other malignancies within the past 5 years, except for adequately treated non-melanoma skin cancer or cervical carcinoma in situ.
• Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that, in the investigator's judgment, may interfere with informed consent or treatment adherence.
• 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.
• History of solid organ transplant requiring ongoing immunosuppressive therapy.
• Known significant active infection, or significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious uncontrolled comorbidities as determined by the investigator.
• Allergy to any component of the study drug(s).
• History of immunodeficiency, including HIV infection, acquired or congenital immunodeficiency disorders, solid organ transplant, or chronic immunosuppressive therapy for immune-related conditions.
• Active or latent tuberculosis infection confirmed by positive T-SPOT.TB test or chest X-ray findings suggestive of tuberculosis.
• Any other condition that, in the investigator's clinical judgment, may compromise study participation or safety.

Sponsors & Collaborators

• Second Affiliated Hospital of Soochow University: lead

MeSH Terms

Conditions

Lymphopenia

Condition Hierarchy (Ancestors)

Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders; Immunologic Deficiency Syndromes; Immune System Diseases

Central Study Contacts

Liyuan Zhang, Doctor

CONTACT

051267784829; zhangliyuan126@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2025
• First Posted: December 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: December 5, 2025

Record last verified: 2025-11