Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06437678
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Phase II Study of Liposomal Irinotecan for Advanced Refractory Gastric Cancer
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
A Single-Center Prospective Phase II Clinical Study of Liposomal Irinotecan Monotherapy for Third-Line and Beyond RecurrentRefractory Advanced Gastric Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the objective response rate ORR and disease control rate DCR of liposomal irinotecan monotherapy in the treatment of recurrentrefractory advanced gastric cancer
Detailed Description:
This study is a single-arm single-center prospective clinical trial aimed at evaluating the efficacy and safety of liposomal irinotecan monotherapy in the treatment of recurrentrefractory advanced gastric cancer The study targets patients with locally advanced recurrent or metastaticprevious treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction The primary endpoints of the study are objective response rate ORR and disease control rate DCR It plans to enroll 50 patients with locally advanced recurrent or metastaticprevious treatment-refractory adenocarcinoma of the stomach or gastroesophageal junction Subjects will sign informed consent and undergo screening for eligibility before enrollment Subjects will receive the following treatment Liposomal Irinotecan Hydrochloride Injection Ⅱ 565mgm2 every 2 weeks Safety visits will be conducted on Day 1 of each treatment cycle at the end of the study treatment and 30 days 7 days after the end of the study treatment Imaging assessments will be performed according to RECIST 11 criteria including chest CT enhanced CT scans of the abdomen and pelvis or chest CT plain scan plus abdominalpelvic MRI scan for patients allergic to contrast agents Suspected cases of brain metastases will require brain enhanced MRI or enhanced CT Bone scan examination will be conducted if bone metastases are suspected clinically or radiologically Patients who discontinue treatment due to reasons other than radiological progression during the treatment period will undergo imaging examination at the end of treatment unless it has been conducted within 28 days Subjects will undergo survival follow-up every 3 months after the end of treatment to collect and record survival status and subsequent anti-tumor treatment until death or loss to follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None