search
Back to results

A Study of Endostar Combined With Chemotherapy and Immunotherapy in Lung Squamous Cell Carcinom

Primary Purpose

Lung Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
Sponsored by
Xuzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Squamous Cell Carcinoma

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 1. Provided written informed consent before performing any trial-related procedures; 2. Aged from 18 to 75 years old (including 75 years old); 3. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of Lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy; 4. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1); Exclusion Criteria: If the tumor had invaded large blood vessels on imaging (CT or MRI), or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; Currently participating in an interventional clinical study treatment or receiving another study drug or study device within 4 weeks before the first dose; Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention; Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias; Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; Known allergic reactions to the study drugs; Patients requiring long-term systemic corticosteroids. Patients who required intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroid injections due to COPD or asthma were eligible. Symptomatic central nervous system metastases Patients with asymptomatic brain metastases or symptomatic stabilization of treated brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; No metastasis was found in midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord. Maintain a clinically stable state for at least 2 weeks; Hormone therapy was stopped 3 days before the first dose of study drug; Active infection requiring treatment or use of systemic anti-infective agents within 1 week before the first dose; Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia); Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center);

Sites / Locations

  • Yancheng Clinical College of Xuzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

Arm Description

Recombinant human endostatin (CIV72h, D1-D3, 14 tubes) was administered by continuous intravenous infusion every 3 weeks. The drug was discontinued until disease progression or intolerable side effects.

Outcomes

Primary Outcome Measures

PFS
Progression-free survival time
ORR
objective response rate
AE
adverse reactions

Secondary Outcome Measures

OS
overall survival

Full Information

First Posted
March 4, 2023
Last Updated
March 21, 2023
Sponsor
Xuzhou Medical University
search

1. Study Identification

Unique Protocol Identification Number
NCT05782764
Brief Title
A Study of Endostar Combined With Chemotherapy and Immunotherapy in Lung Squamous Cell Carcinom
Official Title
A Single-arm, Exploratory Clinical Study of 3-day Continuous Intravenous Pump of Endostatin (Endostar) Combined With Chemotherapy and Immune Checkpoint Inhibitor in the Treatment of Advanced Lung Squamous Cell Carcinom
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
May 30, 2025 (Anticipated)
Study Completion Date
May 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Xuzhou Medical University

4. Oversight

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

5. Study Description

Brief Summary
To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
Detailed Description
This study is a prospective, single-arm, single-center phase II study to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with chemotherapy and recombinant human endostatin in patients with advanced (stage IIIB-IV) squamous non-small cell lung cancer. Patients with locally advanced stage ⅢB/ⅢC, metastatic or recurrent stage IV squamous NSCLC who were not operable and could not receive radical concurrent chemoradiotherapy were selected after signing informed consent. Eligible subjects who met the inclusion criteria were screened for immune checkpoint inhibitor combined with chemotherapy and recombinant human endostatin. After cycles 4 to 6, maintenance therapy with an immune checkpoint inhibitor and endostatin was administered until disease progression, unacceptable toxicity, withdrawal of consent, initiation of additional antineoplastic therapy, death, or other protocol-specified discontinuation of treatment, whichever occurred first.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Squamous Cell Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single arm
Arm Type
Experimental
Arm Description
Recombinant human endostatin (CIV72h, D1-D3, 14 tubes) was administered by continuous intravenous infusion every 3 weeks. The drug was discontinued until disease progression or intolerable side effects.
Intervention Type
Drug
Intervention Name(s)
To explore the efficacy and safety of immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
Other Intervention Name(s)
Endostar combined with immune checkpoint inhibitor and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV)
Intervention Description
immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival time
Time Frame
2months ~ 10 months
Title
ORR
Description
objective response rate
Time Frame
about 10months
Title
AE
Description
adverse reactions
Time Frame
about 10months
Secondary Outcome Measure Information:
Title
OS
Description
overall survival
Time Frame
about 30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
78 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Provided written informed consent before performing any trial-related procedures; 2. Aged from 18 to 75 years old (including 75 years old); 3. Patients with histologically or cytologically confirmed, locally advanced (stage IIIB/IIIC), metastatic, or recurrent (stage IV) squamous NSCLC according to the International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM classification of Lung cancer, who are inoperable and not amenable to definitive concurrent chemoradiotherapy; 4. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1); Exclusion Criteria: If the tumor had invaded large blood vessels on imaging (CT or MRI), or it was judged that the tumor was likely to invade important blood vessels and cause fatal hemorrhage during the follow-up study; Currently participating in an interventional clinical study treatment or receiving another study drug or study device within 4 weeks before the first dose; Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention; Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias; Any arterial thrombosis, embolism, or ischemia, such as myocardial infarction, unstable angina pectoris, cerebrovascular accident, or transient ischemic attack, occurred within 6 months before enrollment; Known allergic reactions to the study drugs; Patients requiring long-term systemic corticosteroids. Patients who required intermittent use of bronchodilators, inhaled corticosteroids, or topical corticosteroid injections due to COPD or asthma were eligible. Symptomatic central nervous system metastases Patients with asymptomatic brain metastases or symptomatic stabilization of treated brain metastases were eligible to participate in the study if they met all the following criteria: measurable disease outside the central nervous system; No metastasis was found in midbrain, pons, cerebellum, meninges, medulla oblongata or spinal cord. Maintain a clinically stable state for at least 2 weeks; Hormone therapy was stopped 3 days before the first dose of study drug; Active infection requiring treatment or use of systemic anti-infective agents within 1 week before the first dose; Has not fully recovered from any intervention-related toxicity and/or complications before starting treatment (i.e., grade ≤1 or baseline, excluding fatigue or alopecia); Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive); Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copies greater than the upper limit of normal in the laboratory of the participating center);
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Min Liu
Phone
+86 66696891
Email
lmin89@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xichao Dai
Organizational Affiliation
Yancheng Clinical College of Xuzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yancheng Clinical College of Xuzhou Medical University
City
Yancheng
State/Province
Jiangsu
ZIP/Postal Code
224001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xichao Dai
Phone
+8666696963
Email
rosefor1110@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Endostar Combined With Chemotherapy and Immunotherapy in Lung Squamous Cell Carcinom

We'll reach out to this number within 24 hrs