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Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer

NCT06486545 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-08-26

No results posted yet for this study

Summary

Liposomal irinotecan, intravenous infusion 90min, d1:

Grade 1:50mg/m2 Grade 2:60mg/m2 Grade 3:70mg/m2 Albumin-paclitaxel, 150mg/m2, intravenous infusion, d1 DLT was observed for 2 weeks (the first cycle). The same subject received only one dose of liposomal irinotecan during the study. All subjects underwent protocol-mandated examinations during treatment to observe safety and initial efficacy. If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks, the subject may continue to receive treatment for metastatic disease. The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed. Until there is a possibility of surgery, disease progression, intolerable toxicity or the patient withdraws informed consent (whichever comes first).

Conditions

  • Advanced Gastric Cancer

Interventions

DRUG

Irinotecan Hydrochloride Liposome Injection；Paclitaxel For Injection (Albumin Bound)

Liposomal irinotecan, intravenous infusion 90min, d1: Grade 1:50mg/m2； Grade 2:60mg/m2； Grade 3:70mg/m2； Albumin-paclitaxel, 150mg/m2, intravenous infusion, d1 DLT was observed for 2 weeks (the first cycle). The same subject received only one dose of liposomal irinotecan during the study. If the patient volunteers and the investigator determines that the benefits of continuing the original regimen outweigh the risks, the subject may continue to receive treatment for metastatic disease. The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed. Until there is a possibility of surgery, disease progression, intolerable toxicity or the patient withdraws informed consent (whichever comes first).

Sponsors & Collaborators

  • Hunan Cancer Hospital

    lead OTHER

Principal Investigators

  • Liu zhenyang, Doctor · Hunan Cancer Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-25
Primary Completion
2025-07-30
Completion
2026-01-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06486545 on ClinicalTrials.gov