Liposomal Irinotecan and Apatinib in ES-SCLC (LIAES)

Study of Liposomal Irinotecan Combined with Apatinib in the Treatment of Extensive Stage Small Cell Lung Cancer After First-line Progression

The purpose of this study is to observe the efficacy and safety of liposomal irinotecan combined with apatinib in the treatment of extensive stage small cell lung cancer progressed from first-line regimen.

Study Overview

• Status: Recruiting
• Conditions: Small Cell Lung Cancer Extensive Stage
• Intervention / Treatment: Drug: Liposomal Irinotecan and Apatinib

Detailed Description

Small cell lung cancer is a highly invasive neuroendocrine tumor characterized by high malignancy and rapid proliferation. Although most patients with extensive SCLC are sensitive to first-line treatments such as etoposide combined with platinum and immunotherapy, most patients experience disease progression again after first-line treatment. Therefore, extending the survival time of patients and improving their quality of life have become key issues in the second-line treatment of SCLC. The current guidelines for second-line treatment of SCLC recommend monotherapy, including topotecan, irinotecan, etc. However, the available options have poor efficacy and are prone to drug resistance. Irinotecan liposomes improve drug stability and prolong circulation time through liposome encapsulation, and target tumor tissues through high permeability and long retention effects, with the expected effect of reducing toxicity and increasing efficacy. Apatinib is a small molecule tyrosine kinase inhibitor that selectively inhibits vascular endothelial growth factor receptors to achieve anti angiogenic and anti-tumor effects. It has been proven to have positive therapeutic effects in multiple types of cancer, including SCLC. At present, the combination mode of chemotherapy and anti-angiogenic drugs has been explored in various tumors, and the results show that this mode has drug synergistic effects, which can significantly improve the efficacy of anti-tumor treatment. Therefore, exploring the efficacy, safety, and mechanism of liposomal irinotecan combined with apatinib is of great clinical and theoretical significance for the refractory tumor population of extensive stage small cell lung cancer with first-line treatment progress.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xian Zhong; Phone Number: 86-571-86993769; Email: zhongxian_2000@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University
      • Contact: Ze Chen; Phone Number: 8657187783759; Email: keyanlunli_zheer@163.com
      • Contact: Xian Zhong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age range of 18-75 years;
2. Expected survival period ≥ 12 weeks;
3. At least one measurable lesion (according to RECIST V 1.1);
4. For patients who have failed first-line or second-line treatment.

Exclusion Criteria:

1. Have received any systemic treatment targeting VEGF or VEGFR in the past, such as treatment with anti angiogenic drugs such as ranibizumab, fipronib, apatinib, anlotinib, lenvatinib, sunitinib, sorafenib.
2. Active or uncontrolled severe infection (CTCAE 5.0 ≥ 2) and/or antibiotic treatment within 2 weeks prior to enrollment;
3. There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;
4. Those deemed unsuitable for inclusion by doctors;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Liposomal Irinotecan and Apatinib	Drug: Liposomal Irinotecan and Apatinib; Liposomal Irinotecan in Combination With Apatinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free-Survival rate at 6 months	Progression-Free-Survival rate at 6 months from enrollment	From enrollment at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	Overall Response Rate	From enrollment to the end of treatment at 6-8 weeks
mPFS	median Progression-Free-Survival time	From enrollment to the end of treatment at 6-8 weeks
mOS	median Overall Survival time	From enrollment to the end of life at 3 months

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Estimated): December 28, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 12, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Apatinib; Small Cell Lung Cancer; Liposomal Irinotecan
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Topoisomerase I Inhibitors; Topoisomerase Inhibitors; Irinotecan; Apatinib
• Other Study ID Numbers: SAH-2024-0770

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No