search
Back to results

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

Primary Purpose

Advanced Solid Tumor, Refractory Tumor

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Radiotherapy
PD-1/PD-L1 inhibitor
Granulocyte-macrophage colony-stimulating factor subcutaneous injection
Interleukin 2 subcutaneous injection
Endostatin
Sponsored by
Second Affiliated Hospital of Soochow University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Solid Tumor

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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; 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.

Sites / Locations

  • The Second Affiliated Hospital of SchoowUniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention group

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 14, 2023
Last Updated
September 14, 2023
Sponsor
Second Affiliated Hospital of Soochow University
search

1. Study Identification

Unique Protocol Identification Number
NCT06047860
Brief Title
A Clinical Study of Recombinant Human Vascular Endothelial Inhibitor in Combination With PRaG for Advanced Refractory Non-small Cell Lung Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital of Soochow University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Solid Tumor, Refractory Tumor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
Radiotherapy
Other Intervention Name(s)
SBRT
Intervention Description
hypofractionated radiotherapy/SBRT
Intervention Type
Drug
Intervention Name(s)
PD-1/PD-L1 inhibitor
Other Intervention Name(s)
PD-1/PD-L1 antibody
Intervention Description
PD-1/PD-L1 inhibitor within one week of radiotherapy
Intervention Type
Drug
Intervention Name(s)
Granulocyte-macrophage colony-stimulating factor subcutaneous injection
Other Intervention Name(s)
GM-CSF
Intervention Description
IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
Intervention Type
Drug
Intervention Name(s)
Interleukin 2 subcutaneous injection
Other Intervention Name(s)
IL-2
Intervention Description
IL-2 2 million IU the day after the end of GM-CSF, administered subcutaneously daily for 7 days;
Intervention Type
Drug
Intervention Name(s)
Endostatin
Other Intervention Name(s)
Endo
Intervention Description
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.
Primary Outcome Measure Information:
Title
overall response rate(ORR)
Description
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.
Time Frame
six weeks
Title
Disease control rate (DCR)
Description
the percentage of patients who have achieved complete response (CR), partial response (PR) and stable disease (SD)
Time Frame
six weeks
Title
Progression free survival (PFS)
Description
The time from commencement of treatment to disease progression or death from any cause.
Time Frame
six weeks
Title
Overall survival (OS)
Description
The time from the first day of enrollment to death from any cause.
Time Frame
six weeks
Title
Incidence of adverse events
Description
the rate of AE
Time Frame
six weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liyuan Zhang
Phone
0512-67784829
Email
zhangliyuan126@126.com
Facility Information:
Facility Name
The Second Affiliated Hospital of SchoowUniversity
City
Suzhou
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengfei Xing
Phone
13862069147
Email
drxingpengfei@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs