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AzTrials

Advanced Solid TumorPhase 2NCT06047860

A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor in Combination With PRaG for Advanced Refractory Non-small Cell Lung Cancer

A Phase 2 study testing Radiotherapy, PD-1/PD-L1 inhibitor and Granulocyte-macrophage colony-stimulating factor subcutaneous injection in people with Advanced Solid Tumor and Refractory Tumor, run by Second Affiliated Hospital of Soochow University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Exploring the efficacy and safety of recombinant human vascular endothelial inhibitor (Endo) in combination with Bragg therapy in advanced refractory non-small cell lung Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor, Refractory Tumor
What is being tested?
Radiotherapy, PD-1/PD-L1 inhibitor and Granulocyte-macrophage colony-stimulating factor subcutaneous injection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
16 Jun 2023to 31 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-75 years;
  • Patients enrolled must be eligible for patients with recurrent or metastatic advanced non-small cell lung cancer, with a clear pathological diagnosis report or history of disease, with guidelines that do not clearly recommend standard treatment regimens or who are unable to tolerate standard treatment regimens, and with clear measurable metastatic lesions (>1cm);
  • No congestive heart failure, unstable angina, or unstable arrhythmia within the last 6 months.
  • Patient activity status score of 0-3 on the Eastern Cooperative Oncology Group (ECOG) scale with life expectancy assessed at ≥3 months.
  • No previous severe haematopoietic, cardiac, pulmonary, hepatic or renal abnormalities and immunodeficiency.
  • Absolute T-lymphocyte values ≥ 0.5 times the lower limit of normal and neutrophils ≥ 1.0 x 109/L; AST and ALT ≤ 3.0 times the upper limit of normal (≤ 5.0 times the upper limit of normal for hepatocellular carcinoma/metastatic liver cancer); creatinine ≤ 3.0 times the upper limit of normal, 1 week prior to enrollment.
  • Patients must have the ability to understand and voluntarily sign the informed consent form.

Who cannot join

  • Pregnant or breastfeeding women;
  • Persons with a history of other malignant disease in the last 5 years, except cured skin cancer and carcinoma in situ of the cervix;
  • Persons with a history of uncontrolled epilepsy, central nervous system disorders or psychiatric disorders whose clinical severity, as judged by the investigator, may prevent the signing of an informed consent or affect the patient's compliance with drug therapy;
  • Clinically significant (i.e., active) cardiac disease such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months;
  • Persons requiring immunosuppressive therapy for organ transplantation;
  • Known major active infection or, in the judgement of the investigator, major haematological, renal, metabolic, gastrointestinal, endocrine dysfunction or metabolic disorders, or other serious uncontrolled concomitant disease;
Show all 11Show fewer
  • Hypersensitivity to any investigational drug component;
  • Persons with a history of immunodeficiency, including those who have tested positive for HIV or have other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy
  • Persons with active tuberculosis infection;
  • Those with interstitial lung disease or non-infectious pneumonia that may prevent the assessment of pulmonary toxicity associated with the study or the manager;
  • Other conditions that, in the opinion of the investigator, are not suitable for enrolment.

Trial locations and contacts

1 site in 1 country.

Liyuan Zhang contact

0512-67784829

zhangliyuan126@126.com

China1 site, 1 recruiting

  • The Second Affiliated Hospital of SchoowUniversity

    Suzhou, 215004

    Pengfei Xing, 13862069147, drxingpengfei@126.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor (Endo) in Combination With Bragg Treatment for Advanced Refractory Non-small Cell Lung Cancer

Exploring the efficacy and safety of recombinant human vascular endothelial inhibitor (Endo) in combination with Bragg therapy in advanced refractory non-small cell lung

Read the detailed description

Radiotherapy:

Start radiotherapy on the first day of treatment, as described in 6.2 above;

GM-CSF treatment:

GM-CSF 200 μg on the first day of treatment, administered subcutaneously daily for 7 days; IL-2 treatment. 2 million IU of IL-2 on the day after GM-CSF, administered subcutaneously daily for 7 days;

Immunotherapy:

PD-1/PD-L1 inhibitors within one week of radiotherapy;

Recombinant human vascular endothelial inhibitor (Endo):

Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h starting on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy.

Maintenance treatment phase:

Maintenance with PD-1/PD-L1 inhibitor in combination with recombinant human vascular endothelial inhibitor (Endo) until progression or intolerable side effects.

Being tested
Radiotherapy, PD-1/PD-L1 inhibitor, Granulocyte-macrophage colony-stimulating factor subcutaneous injection, Interleukin 2 subcutaneous injection, Endostatin
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RadiotherapyRadiation

    Also called SBRT

    hypofractionated radiotherapy/SBRT

  • PD-1/PD-L1 inhibitorDrug

    Also called PD-1/PD-L1 antibody

    PD-1/PD-L1 inhibitor within one week of radiotherapy

  • Granulocyte-macrophage colony-stimulating factor subcutaneous injectionDrug

    Also called GM-CSF

    IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;

  • Interleukin 2 subcutaneous injectionDrug

    Also called IL-2

    IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;

  • EndostatinDrug

    Also called Endo

    Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h was started on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy.

Study groups in NCT06047860
Study groupRoleWhat they receive
Intervention groupExperimentalM-CSF 200 μg administered subcutaneously daily for 7 days on the first day of treatment; IL-2 2 million IU administered subcutaneously daily for 7 days the day after GM-CSF; PD-1/PD-L1 inhibitor within one week of radiotherapy; Recombinant human vascular endothelial inhibitor (Endo) 210 mg CIV72h starting on the first day of treatment, every 21 days for a minimum of ≥ 2 cycles of this combination therapy. Maintenance treatment phase: Maintenance with PD-1/PD-L1 inhibitor in combination with recombinant human vascular endothelial inhibitor (Endo) until progression or intolerable side effects.
Receives: Radiation: Radiotherapy; Drug: PD-1/PD-L1 inhibitor; Drug: Granulocyte-macrophage colony-stimulating factor subcutaneous injection; Drug: Interleukin 2 subcutaneous injection; Drug: Endostatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall response rate(ORR)

    ORR is defined as the proportion of patients who have a partial (PR) or complete response (CR) to therapy among the total number of evaluable patients.

    Measured: six weeks

  2. Disease control rate (DCR)

    the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)

    Measured: six weeks

  3. Progression free survival (PFS)

    The time from commencement of treatment to disease progression or death from any cause.

    Measured: six weeks

  4. Overall survival (OS)

    The time from the first day of enrollment to death from any cause.

    Measured: six weeks

  5. Incidence of adverse events

    the rate of AE

    Measured: six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start16 Jun 2023
  3. Primary completion30 Dec 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06047860
Sponsor's protocol ID
JD-LK-2022-173-01
Status last verified
Sep 2023
First submitted
14 Sep 2023
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huang S, Yang X, Zhao X, Kong Y, Zhang L, Xing P. Endostar combined with PD-1 blockade, radiotherapy, GM-CSF, and IL-2 (PRaG 2.0E) for refractory non-small cell lung cancer: a single-arm, phase II clinical trial (PRaG2.0E Study Protocol). Transl Lung Cancer Res. 2026 May 31;15(5):153. doi: 10.21037/tlcr-2026-1-0203. Epub 2026 May 26.

    PubMed 42291342

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Radiotherapy, PD-1/PD-L1 inhibitor and Granulocyte-macrophage colony-stimulating factor subcutaneous injection in people with Advanced Solid Tumor and Refractory Tumor, 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 11 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: status not confirmed, as of the sponsor's last update on 21 Sep 2023. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Liyuan Zhang (0512-67784829, zhangliyuan126@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall response rate(ORR) (time frame: six weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06047860, which also lists 1 linked publication.

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 21 Sep 2023.

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