Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment … (NCT06417892) | Clinical Trial Compass
RecruitingNot Applicable
Fruquintinib and Albumin-paclitaxel Combined With or Without PD-1 Antibody in 2nd-line Treatment of G/GEJ Adenocarcinoma
China60 participantsStarted 2024-04-15
Plain-language summary
To explore the efficacy and safety of fruquintinib and albumin-paclitaxel combined with or without PD-1 antibody in the second-line treatment of advanced gastric/gastroesophageal junction adenocarcinoma that failed to be treated by anti-PD-1 /PD-L1 regimen
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Have fully understood the study and voluntarily signed the informed consent;
✓. Age ≥18 years old;
✓. Pathologically confirmed advanced gastric/gastroesophageal junction adenocarcinoma with at least one systemic treatment;
✓. Frontline experienced exposure to immune drugs (including exposure to PD-1 drugs in the neoadjuvant, adjuvant, and systemic treatment stages; For patients with metastasis and recurrence within 6 months after the end of adjuvant/neoadjuvant system treatment, the above-mentioned treatment is first-line treatment);
✓. ECOG's physical condition was 0-1, and did not deteriorate within 7 days;
✓. BMI≥18;
✓. Expected survival ≥3 months;
✓. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors is not allowed within the first 14 days of enrollment) a) Absolute neutrophil count ≥1.5×109/L, white blood cell ≥4.0×109/L; b) Platelet ≥100×109/L; c) Hemoglobin ≥90g/L; d) Total bilirubin TBIL≤1.5 times ULN; e)ALT and AST≤2.5 times ULN (up to 5 times in patients with liver metastasis); f) Urea/urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min); g) Left ventricular ejection fraction (LVEF) ≥50%; h)Fridericia's corrected QT interval (QTcF) \<470 ms. i) INR≤1.5 x ULN, APTT≤1.5 x ULN.
Exclusion criteria
✕. Failure to comply with the study protocol or study procedure;
✕
What they're measuring
1
PFS
Timeframe: 2 years
Trial details
NCT IDNCT06417892
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
✕. Previously received paclitaxel therapy (except for those who received paclitaxel therapy in neoadjuvant or adjuvant therapy, and the treatment ended more than 6 months after the progression of the disease);
✕. Known HER-2 positive patients;
✕. Receive live vaccine within 4 weeks prior to enrollment or possibly during the study period;
✕. Had other malignancies within 5 years prior to enrollment, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
✕. Had active autoimmune disease or history of autoimmune disease within 4 weeks prior to enrollment;
✕. Previously received allogeneic bone marrow transplantation or organ transplantation;