Liposomal Irinotecan Combination Regimen for Second-line Treatment of Advanced Gastric Cancer

Launched by HUNAN CANCER HOSPITAL · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment combination for patients with advanced gastric cancer, which is a type of stomach cancer that has spread and cannot be surgically removed. The study will test the effects of two medications: liposomal irinotecan and albumin-paclitaxel. Patients who have already received treatment but their cancer has progressed may be eligible to participate. To qualify, participants need to be at least 18 years old, have a confirmed diagnosis of advanced gastric cancer, and be able to provide informed consent to join the study.

If you join this trial, you will receive the study medications through an intravenous infusion, which takes about 90 minutes. Treatment will occur every two weeks for up to six cycles, depending on how well you tolerate the medications and whether your cancer shows signs of improvement. Throughout the study, your health will be closely monitored to ensure safety and determine how effective the treatment is. It's important to note that if you experience any serious side effects, the researchers may adjust your treatment or decide to stop it altogether. If you are interested in this trial, please discuss it with your doctor to see if it’s a good option for you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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