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

Sponsor
Hunan Cancer Hospital
Study ID
NCT06486545
Status
Not Yet Recruiting

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Conditions

  • Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan Hydrochloride Liposome Injection；Paclitaxel For Injection (Albumin Bound) — DRUG
    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 The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed.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).

Study Details

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 The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed.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).

Key Dates

Start date
Aug 25, 2024
Status verified
Jun 2024
Primary completion
Jul 30, 2025
Completion
Jan 30, 2026

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Liposomal irinotecan + Albumin-paclitaxel
    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

Primary Outcome Measure

Maximum tolerated dose [ Time Frame: From the recorded first dose of Liposomal irinotecan to 4 weeks after the recorded last dose of Liposomal irinotecan. ]

Central Contacts

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