Status:
NOT_YET_RECRUITING
Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer
Lead Sponsor:
Hunan Cancer Hospital
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 cy...
Detailed Description
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 ca...
Eligibility Criteria
Inclusion
- 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
- Patients who have progressed after previous first-line treatment based on fluorouracil
- HER-2+ is known to have been previously trastuzumab or HER-2 negative
- According to RECIST1.1 criteria, the patient had at least one measurable target lesion
- Eastern Cooperative Oncology Group（ECOG）Physical status score: 0-2
- Absolute neutrophil count (ANC) ≥1.5×10\^9/L, platelets ≥100×10\^9/L, and hemoglobin ≥90 g/L
- Serum creatinine ≤1.5 times the upper limit of normal value; AST and ALT ≤2.5 times the upper limit of normal (≤5 times the upper limit of normal for patients with liver invasion); Total bilirubin ≤1.5 times the upper limit of normal (≤3 times the upper limit of normal for patients with liver invasion)
- There are no contraindications for the use of liposomal irinotecan and albumin paclitaxel
- Women of childbearing age must have had a pregnancy test (serological) negative within 7 days prior to enrollment and be willing to use an appropriate method of contraception during the trial
- Agree to provide histological samples
Exclusion
- 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.)
- Imaging confirmed intestinal obstruction
- It has uncontrollable ascites, abdominal infection and pyloric obstruction
- Hepatitis B, hepatitis C active infection (hepatitis B surface antigen positive and hepatitis B DNA more than 1x103 copies /mL; more than 1x103 copies /mL of HCV RNA)
- Human immunodeficiency virus (HIV) infection (HIV antibody positive)
- Previous or current co-occurrence of other malignancies (in addition to non-melanoma basal cell carcinoma of the skin that is effectively controlled, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the past five years)
- Pregnant and lactating women and patients of childbearing age who do not want to use contraception
- The investigators determined that patients were not suitable to participate in this study
Key Trial Info
Start Date :
August 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06486545
Start Date
August 25 2024
End Date
January 30 2026
Last Update
August 26 2024
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.