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

NCT ID: NCT05782764

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-05-30

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.

Conditions

Lung Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

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.

Group Type: EXPERIMENTAL

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).

Intervention Type: DRUG

immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).

Interventions

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).

immune checkpoint inhibitor combined with endostar and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV).

Intervention Type: DRUG

Other Intervention Names

Endostar combined with immune checkpoint inhibitor and chemotherapy in the treatment of advanced lung squamous cell carcinoma (stage IIIB-IV)

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

1. 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;

2. Currently participating in an interventional clinical study treatment or receiving another study drug or study device within 4 weeks before the first dose;

3. Presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction, and peritoneal metastasis requiring clinical intervention;

4. Grade III-IV congestive heart failure (New York Heart Association class) with poorly controlled clinically significant arrhythmias;

5. 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;

6. Known allergic reactions to the study drugs;

7. 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.

8. 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;

9. Active infection requiring treatment or use of systemic anti-infective agents within 1 week before the first dose;

10. 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);

11. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1/2 antibody positive);

12. 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);

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuzhou Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xichao Dai

Yancheng Clinical College

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xichao Dai

Role: PRINCIPAL_INVESTIGATOR

Yancheng Clinical College of Xuzhou Medical University

Locations

Yancheng Clinical College of Xuzhou Medical University

Yancheng, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Min Liu

Role: CONTACT

lmin89@163.com

+86 66696891

Facility Contacts

Xichao Dai

Role: primary

rosefor1110@163.com

+8666696963

Other Identifiers

2023-003

Identifier Type: -

Identifier Source: org_study_id