Health TrialsbyHealthPanel

Liposomal Irinotecan and Apatinib in ES-SCLC

ConditionSmall Cell Lung Cancer Extensive Stage
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Those deemed unsuitable for inclusion by doctors;

Trial design

Design model

Single group

Treatments tested in this trial

  • Liposomal Irinotecan and Apatinib

    Drug

    Liposomal Irinotecan in Combination With Apatinib

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Liposomal Irinotecan and ApatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Progression-Free-Survival rate at 6 months

Progression-Free-Survival rate at 6 months from enrollment

Time frame
From enrollment at 6 months

Secondary outcomes

1

ORR

Overall Response Rate

Time frame
From enrollment to the end of treatment at 6-8 weeks
2

mPFS

median Progression-Free-Survival time

Time frame
From enrollment to the end of treatment at 6-8 weeks
3

mOS

median Overall Survival time

Time frame
From enrollment to the end of life at 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov
Apply now