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

Last updated: March 21, 2023
Sponsor: Xuzhou Medical University
Overall Status: Active - Recruiting

Phase

4

Condition

Lung Cancer

Squamous Cell Carcinoma

Treatment

N/A

Clinical Study ID

NCT05782764
2023-003
  • Ages 18-78
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

    1. Provided written informed consent before performing any trial-related procedures;
  1. Aged from 18 to 75 years old (including 75 years old);
  2. Patients with histologically or cytologically confirmed, locally advanced (stageIIIB/IIIC), metastatic, or recurrent (stage IV) squamous NSCLC according to theInternational Association for the Study of Lung Cancer and American Joint Committee onClassification of Cancer 8th Edition TNM classification of Lung cancer, who areinoperable and not amenable to definitive concurrent chemoradiotherapy;
  3. At least one radiographic measurable lesion according to response evaluationCriteria in Solid Tumors (RECIST, version 1.1);

Exclusion

Exclusion Criteria:

  1. If the tumor had invaded large blood vessels on imaging (CT or MRI), or it was judgedthat the tumor was likely to invade important blood vessels and cause fatal hemorrhageduring the follow-up study;
  2. Currently participating in an interventional clinical study treatment or receivinganother 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 clinicalintervention;
  4. Grade III-IV congestive heart failure (New York Heart Association class) with poorlycontrolled 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 requiredintermittent use of bronchodilators, inhaled corticosteroids, or topicalcorticosteroid injections due to COPD or asthma were eligible.
  8. Symptomatic central nervous system metastases Patients with asymptomatic brainmetastases or symptomatic stabilization of treated brain metastases were eligible toparticipate in the study if they met all the following criteria: measurable diseaseoutside the central nervous system; No metastasis was found in midbrain, pons,cerebellum, meninges, medulla oblongata or spinal cord. Maintain a clinically stablestate for at least 2 weeks; Hormone therapy was stopped 3 days before the first doseof study drug;
  9. Active infection requiring treatment or use of systemic anti-infective agents within 1week before the first dose;
  10. Has not fully recovered from any intervention-related toxicity and/or complicationsbefore 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 antibodypositive);
  12. Untreated active hepatitis B (defined as both HBsAg positivity and HBV-DNA copiesgreater than the upper limit of normal in the laboratory of the participating center);

Study Design

Total Participants: 30
Study Start date:
June 01, 2023
Estimated Completion Date:
May 30, 2025

Study 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.

Connect with a study center

  • Yancheng Clinical College of Xuzhou Medical University

    Yancheng, Jiangsu 224001
    China

    Active - Recruiting

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