PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSecond Affiliated Hospital of Soochow University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
PD -1/PD-L1 monoclonal antibody
DrugPRaG-1 Cordycepin Tablets+ Radiotherapy+ GM-CSF+ PD-1/PD-L1 inhibitors
Treatment groups
65 Participants
are divided into 1 treatment groupGroup A: treatmentExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
36 monthsSecondary outcomes
1
Disease control rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD).
Time frame
36 months2
Progression-free Survival (PFS)
PFS was defined as the time from the first administration of study treatment to the first occurrence of disease progression as determined by investigator using RECIST v1.1 or death from any cause, whichever comes first.
Time frame
36 months3
Adverse event
rate of adverse events
Time frame
36 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: