Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer
- Conditions
- Advanced Gastric Cancer
- Registration Number
- NCT06486545
- Lead Sponsor
- Hunan Cancer Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria:<br><br> - Patients fully understand the study, voluntarily participate and sign an informed<br> consent form (ICF)<br><br> - Age =18 years<br><br> - The expected survival time is =3 months<br><br> - Patients with histologically or pathologically confirmed unresectable or locally<br> advanced gastric cancer and gastro-oesophageal junction adenocarcinoma<br><br> - Patients who have progressed after previous first-line treatment based on<br> fluorouracil<br><br> - HER-2+ is known to have been previously trastuzumab or HER-2 negative<br><br> - According to RECIST1.1 criteria, the patient had at least one measurable target<br> lesion<br><br> - Eastern Cooperative Oncology Group(ECOG)Physical status score: 0-2<br><br> - Absolute neutrophil count (ANC) =1.5×10^9/L, platelets =100×10^9/L, and hemoglobin<br> =90 g/L<br><br> - Serum creatinine =1.5 times the upper limit of normal value; AST and ALT =2.5 times<br> the upper limit of normal (=5 times the upper limit of normal for patients with<br> liver invasion); Total bilirubin =1.5 times the upper limit of normal (=3 times the<br> upper limit of normal for patients with liver invasion)<br><br> - There are no contraindications for the use of liposomal irinotecan and albumin<br> paclitaxel<br><br> - Women of childbearing age must have had a pregnancy test (serological) negative<br> within 7 days prior to enrollment and be willing to use an appropriate method of<br> contraception during the trial<br><br> - Agree to provide histological samples<br><br>Exclusion Criteria:<br><br> - Allergic reaction to any investigational drug or its ingredients<br><br> - Patients with relapse within 6 months after previous first-line treatment with<br> paclitaxel<br><br> - The investigational agent was a CYP3A4 strong inducer within 2 weeks prior to<br> initial administration, or a CYP3A4 strong depressant or UGT1A1 strong depressant<br> within 1 week<br><br> - Uncontrolled systemic diseases (e.g. advanced infections, uncontrolled hypertension,<br> diabetes, etc.)<br><br> - Imaging confirmed intestinal obstruction<br><br> - It has uncontrollable ascites, abdominal infection and pyloric obstruction<br><br> - Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and<br> hepatitis B DNA more than 1x103 copies /mL; more than 1x103 copies /mL of HCV RNA)<br><br> - Human immunodeficiency virus (HIV) infection (HIV antibody positive)<br><br> - Previous or current co-occurrence of other malignancies (in addition to non-melanoma<br> basal cell carcinoma of the skin that is effectively controlled, breast/cervical<br> carcinoma in situ, and other malignancies that have been effectively controlled<br> without treatment within the past five years)<br><br> - Pregnant and lactating women and patients of childbearing age who do not want to use<br> contraception<br><br> - The investigators determined that patients were not suitable to participate in this<br> study
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum tolerated dose
- Secondary Outcome Measures
Name Time Method Dose-limiting Toxicity (DLT) of liposomal irinotecan;Objective response rate;Disease control rate;Progression-free survival;Overall survival