Liposomal Irinotecan and Apatinib in ES-SCLC

NCT06749691 | Recruiting Phase 2

• 1 other identifier: SAH-2024-0770
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

Small Cell Lung Cancer; Liposomal Irinotecan; Apatinib

Outcome Measures

Primary Outcomes (1)

• Progression-Free-Survival rate at 6 months

  Progression-Free-Survival rate at 6 months from enrollment

  From enrollment at 6 months

Secondary Outcomes (3)

• ORR

  From enrollment to the end of treatment at 6-8 weeks

• mPFS

  From enrollment to the end of treatment at 6-8 weeks

• mOS

  From enrollment to the end of life at 3 months

Study Arms (1)

Liposomal Irinotecan and Apatinib

EXPERIMENTAL

Drug: Liposomal Irinotecan and Apatinib

Interventions

Liposomal Irinotecan and Apatinib DRUG

Liposomal Irinotecan in Combination With Apatinib

Liposomal Irinotecan and Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Active or uncontrolled severe infection (CTCAE 5.0 ≥ 2) and/or antibiotic treatment within 2 weeks prior to enrollment;
• There are multiple factors that affect the absorption of oral medication, such as inability to swallow, nausea and vomiting, chronic diarrhea, and intestinal obstruction;

Sponsors & Collaborators

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

Study Sites (1)

Second Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

irinotecan sucrosofate; apatinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xian Zhong

CONTACT

86-571-86993769; zhongxian_2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: December 27, 2024
• Study Start: December 28, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)