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

September 14, 2023 updated by: Second Affiliated Hospital of Soochow University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Suzhou, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of SchoowUniversity
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patients aged 18-75 years;
  2. 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);
  3. No congestive heart failure, unstable angina, or unstable arrhythmia within the last 6 months.
  4. Patient activity status score of 0-3 on the Eastern Cooperative Oncology Group (ECOG) scale with life expectancy assessed at ≥3 months.
  5. No previous severe haematopoietic, cardiac, pulmonary, hepatic or renal abnormalities and immunodeficiency.
  6. 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.
  7. Patients must have the ability to understand and voluntarily sign the informed consent form.

Exclusion Criteria:

  1. Pregnant or breastfeeding women;
  2. Persons with a history of other malignant disease in the last 5 years, except cured skin cancer and carcinoma in situ of the cervix;
  3. 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;
  4. 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;
  5. Persons requiring immunosuppressive therapy for organ transplantation;
  6. 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;
  7. Hypersensitivity to any investigational drug component;
  8. 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
  9. Persons with active tuberculosis infection;
  10. Those with interstitial lung disease or non-infectious pneumonia that may prevent the assessment of pulmonary toxicity associated with the study or the manager;
  11. Other conditions that, in the opinion of the investigator, are not suitable for enrolment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group

M-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.
Radiation: Radiotherapy
hypofractionated radiotherapy/SBRT
Other Names:
  • SBRT
Drug: PD-1/PD-L1 inhibitor
PD-1/PD-L1 inhibitor within one week of radiotherapy
Other Names:
  • PD-1/PD-L1 antibody
Drug: Granulocyte-macrophage colony-stimulating factor subcutaneous injection
IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
Other Names:
  • GM-CSF
Drug: Interleukin 2 subcutaneous injection
IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
Other Names:
  • IL-2
Drug: Endostatin
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.
Other Names:
  • Endo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
overall response rate(ORR)
Time Frame: six weeks
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.
six weeks
Disease control rate (DCR)
Time Frame: six weeks
the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)
six weeks
Progression free survival (PFS)
Time Frame: six weeks
The time from commencement of treatment to disease progression or death from any cause.
six weeks
Overall survival (OS)
Time Frame: six weeks
The time from the first day of enrollment to death from any cause.
six weeks
Incidence of adverse events
Time Frame: six weeks
the rate of AE
six weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Second Affiliated Hospital of Soochow University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2023

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 14, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JD-LK-2022-173-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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