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 The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed.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).
Patients fully understand the study, voluntarily participate and sign an informed consent form (ICF)
Age ≥18 years
The expected survival time is ≥3 months
Patients with histologically or pathologically confirmed unresectable or locally advanced gastric cancer and gastro-oesophageal junction adenocarcinoma
Allergic reaction to any investigational drug or its ingredients
Patients with relapse within 6 months after previous first-line treatment with paclitaxel
The investigational agent was a CYP3A4 strong inducer within 2 weeks prior to initial administration, or a CYP3A4 strong depressant or UGT1A1 strong depressant within 1 week
Uncontrolled systemic diseases (e.g. advanced infections, uncontrolled hypertension, diabetes, etc.)
Single group
Irinotecan Hydrochloride Liposome Injection；Paclitaxel For Injection (Albumin Bound)
DrugLiposomal 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 The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed.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).
Maximum tolerated dose
To estimate the maximum tolerated dose of liposomal irinotecan in the combination regimen based on dose-limiting toxicity
Dose-limiting Toxicity (DLT) of liposomal irinotecan
One or more adverse events that occurred during the DLT observation period related to the investigational drug (including definitely related, likely related, possibly related) (meeting the DLT criteria)
Objective response rate
Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) using lnvestigator assessments, is defined as the number (%) of paients of Complete Response or Partial Response, will be assessed up to 2 years.
Disease control rate
The percentage of subiects of Complete Response (CR) or Parial Response (PR) or Stable Disease (SD) by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by the investigator, will be assessed up to 2 years.
Progression-free survival
Progression-free survival (PFS) is defined as the time from first dose of Liposomal irinotecan recorded until the date of disease progression based on investigator assessment.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
