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

NCT05782764 | Unknown Phase 4

• 1 other identifier: 2023-003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Lung Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (3)

• PFS

  Progression-free survival time

  2months ~ 10 months

• ORR

  objective response rate

  about 10months

• AE

  adverse reactions

  about 10months

Secondary Outcomes (1)

• OS

  about 30 months

Study Arms (1)

single arm

EXPERIMENTAL

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.

Drug: 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).

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). DRUG

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

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

single arm

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Provided written informed consent before performing any trial-related procedures;
• \. Aged from 18 to 75 years old (including 75 years old);
• \. 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;
• \. At least one radiographic measurable lesion according to response evaluation Criteria in Solid Tumors (RECIST, version 1.1);

You may not qualify if:

• 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);

Sponsors & Collaborators

• Xuzhou Medical University: lead

Study Sites (1)

Yancheng Clinical College of Xuzhou Medical University

Yancheng, Jiangsu, 224001, China

RECRUITING

MeSH Terms

Interventions

endostar protein; Drug Therapy; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Therapeutics; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Officials

• Xichao Dai

  Yancheng Clinical College of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Liu

CONTACT

+86 66696891; lmin89@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Yancheng Clinical College

Study Record Dates

• First Submitted: March 4, 2023
• First Posted: March 24, 2023
• Study Start: June 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)