Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT06467786

Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer

Led by Tang-Du Hospital · Updated on 2024-06-21

24

Participants Needed

1

Research Sites

235 weeks

Total Duration

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AI-Summary

What this Trial Is About

This study is a prospective, multicenter, single arm Phase II exploratory study. It is expected to include 24 first-line patients with small cell lung cancer who have progressed after 6 months of treatment with platinum containing regimens, and receive treatment with irinotecan liposomes combined with cisplatin or carboplatin regimens.

CONDITIONS

Official Title

Study on the Therapeutic Effect of Irinotecan Liposomes in Small Cell Lung Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient understands the study, voluntarily agrees, and signs informed consent.
  • Age 18 years or older.
  • Diagnosed with extensive stage small cell lung cancer by pathology or histology.
  • At least one measurable target lesion according to RECIST 1.1 standards.
  • Disease progression confirmed by imaging after 6 months of first-line platinum-based chemotherapy or chemo-immunotherapy.
  • Eastern Cancer Collaborative Group (ECOG) physical fitness score of 0 to 2.
  • Estimated survival time of at least 3 months.
  • Adequate blood counts: ANC ≥ 1.5 x 10^9/L, platelets ≥ 90 x 10^9/L, hemoglobin ≥ 90 g/L without recent transfusions or growth factors.
  • Liver and kidney function within specified limits: serum creatinine ≤ 1.5 times upper normal; AST and ALT ≤ 2.5 times upper normal (≤ 5 times if liver invasion); total bilirubin ≤ 1.5 times upper normal (≤ 3 times if liver invasion).
  • Women of childbearing age must have a negative pregnancy test within 7 days before enrollment and agree to use contraception during and for 6 months after the study.
Not Eligible

You will not qualify if you...

  • Diagnosis of large cell neuroendocrine tumors or mixed small cell carcinoma.
  • Active brain metastases or central nervous system invasion confirmed by imaging or biopsy.
  • Hypersensitivity to any study drug or its components.
  • Severe uncontrolled infections or serious uncontrolled diseases, including moderate or severe kidney injury.
  • Significant heart conditions including long QTc syndrome, severe arrhythmias, advanced heart failure (NYHA class III or higher), low ejection fraction below 50%, recent myocardial infarction or unstable angina.
  • Active hepatitis B or C infection above specified viral load thresholds.
  • HIV infection.
  • Previous or current other malignant tumors except certain effectively controlled cases within five years.
  • Pregnant or breastfeeding women, or women unwilling to use contraception.
  • Other malignant tumors requiring treatment or judged unsuitable for the study by researchers.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tangdu Hospital

Xi'an, Shannxi, China, 710038

Actively Recruiting

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Research Team

H

Haichuan Su, PhD

CONTACT

J

Jie Min, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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