Solid CancerPhase 2NCT07267234
PRaG-1 Plus PRaG Therapy in in Elderly Patients With Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)
A Phase 2 study testing PD -1/PD-L1 monoclonal antibody in people with Solid Cancer and Lymphopenia, run by Second Affiliated Hospital of Soochow University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Cancer, Lymphopenia, Radiotherapy
- What is being tested?
- PD -1/PD-L1 monoclonal antibody
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 65 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Dr. Zhang, 67784829, zhangliyuan126@126.com
About this study
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?
Read more
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.
Read the detailed description
- 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.
- 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.
- 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.
- Conditions
- Solid Cancer, Lymphopenia, Radiotherapy, Immune Checkpoint Inhibitor
- Being tested
- PD -1/PD-L1 monoclonal antibody
- Medical subject headings
- Lymphopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD -1/PD-L1 monoclonal antibodyDrug
PRaG-1 Cordycepin Tablets+ Radiotherapy+ GM-CSF+ PD-1/PD-L1 inhibitors
| Study group | Role | What they receive |
|---|---|---|
| treatment | Experimental | Not described Receives: Drug: PD -1/PD-L1 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate #ORR#
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
Measured: 36 months
Secondary outcomes (3)
Disease control rate (DCR)
DCR was defined as the percentage of participants with a complete response (CR), partial response (PR), or stable disease (SD).
Measured: 36 months
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.
Measured: 36 months
Adverse event
rate of adverse events
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267234
- Sponsor's protocol ID
- JD-LK2025017-IR01
- Status last verified
- Nov 2025
- First submitted
- 24 Nov 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRaG-1 Plus PRaG Therapy in in Elderly Patients With Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)
- ClinicalTrials.gov ID
- NCT07267234
- Acronym / sponsor ID
- JD-LK2025017-IR01
- Conditions
- Solid Cancer, Lymphopenia, Radiotherapy, Immune Checkpoint Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment | Experimental | Drug: PD -1/PD-L1 monoclonal antibody |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 65 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PD -1/PD-L1 monoclonal antibodyPRaG-1 Cordycepin Tablets+ Radiotherapy+ GM-CSF+ PD-1/PD-L1 inhibitors | Drug | treatment |
Primary outcome
Objective Response Rate #ORR#
Time frame: 36 months
Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).
3 secondary outcomes
Disease control rate (DCR)
Time frame: 36 months
Progression-free Survival (PFS)
Time frame: 36 months
Adverse event
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PD -1/PD-L1 monoclonal antibody in people with Solid Cancer and Lymphopenia, run by Second Affiliated Hospital of Soochow University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyuan Zhang, Doctor (051267784829, zhangliyuan126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate #ORR# (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.