An interventional study of Irinotecan Hydrochloride Liposome Injection；Paclitaxel For Injection (Albumin Bound) in Advanced Gastric Cancer, sponsored by Hunan Cancer Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Hunan Cancer Hospital · Not applicable, Interventional, and Treatment
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 The drug was repeated every 2 weeks for up to 6 cycles, and the albumin paclitaxel or liposomal irinotecan were withdrawn according to the patient's adverse reactions and physical status, and the remaining single-agent maintenance therapy was performed.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).
This is a single-arm, single-center clinical study to evaluate the efficacy and safety of liposomal irinotecan combined with albumin paclitaxel regimen for second-line treatment of advanced gastric cancer. Using a "3+3" study design, 9 to 18 eligible patients with unresectable or locally advanced gastric cancer and gastroesophageal junction adenocarcinoma will receive liposomal irinotecan + albumin paclitaxel combination therapy.
Three dose groups of liposomal irinotecan 50mg/m2, 60 mg/m2 and 70 mg/m2 were preset, and a fixed dose of albumin paclitaxel (150mg/m2, intravenous infusion, d1) was administered for one cycle. The dose of liposomal irinotecan was gradually increased from the low-dose group to the high-dose group, and 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).
Main study indicators: Maximum tolerated dose (MTD) of liposomal irinotecan in the combination regimen; Secondary study measures: dose-limiting toxicity (DLT) of liposomal irinotecan, objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) .
2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.
This study's planned enrollment of 18 is below the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.
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Exclusion Criteria:
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
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).
Maximum tolerated dose
To estimate the maximum tolerated dose of liposomal irinotecan in the combination regimen based on dose-limiting toxicity
Time frame: From the recorded first dose of Liposomal irinotecan to 4 weeks after the recorded last dose of Liposomal irinotecan.
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)
Time frame: From the recorded first dose of Liposomal irinotecan to 4 weeks after the recorded last dose of Liposomal irinotecan.
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.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, 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.
Time frame: Data obtained up until progression, or the last evaluable assessment in the absence of progression, 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.
Time frame: Progression-free survival (PFS) analysis based on investigator assessment per RECIST 1.1, and will be assessed up to 2 years.
Overall survival
Overall survival is defined as the time from begining of Liposomal irinotecan treatment until death due to any cause and wil be assessed up to 3 years.
Time frame: The time from beginning of Liposomal irinotecan treatment until death due to any cause and will be assessed up to 3 years.
No study locations are listed for this record.
Plan to share: Yes — Information about this clinical study will be posted on the Chinese Clinical Trials Registry or clinicaltrials.gov website
Supporting information: Study protocol, Informed consent form
No publications or documents are linked to this record.
Start is estimated for Aug 2024; primary completion for Jul 2025, 11 months later.
Of 309 non-industry interventional studies with no phase under Stomach Neoplasms, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 66. This study's planned 11 months is below that.
Counting every sponsor, half of 318 studies reached it within 37 months; a quarter within 19 and three quarters within 66.
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This study is status unknown, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Hunan Cancer Hospital