Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic … (NCT07389876) | Clinical Trial Compass
RecruitingNot Applicable
Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ Adenocarcinoma
China250 participantsStarted 2025-09-01
Plain-language summary
This study is an open-label, multi-cohort real-world research that explores the efficacy and safety of different second-line treatment regimens for gastric/gastroesophageal junction adenocarcinoma that has failed first-line fluoropyrimidine, platinum-based chemotherapy combined with immunotherapy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
* Fully understand this study and voluntarily sign the informed consent form;
* Between 18 and 80 years old (inclusive), male or female;
* Patients with unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology;
* ECOG performance status 0-2;
* Known HER2 negative;
* Expected survival ≥ 3 months;
* Patients who have progressed on first-line systemic treatment with fluoropyrimidine-platinum combination and PD-1/PD-L1 monoclonal antibody, or those who have progressed during maintenance treatment; patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma who have progressed within 6 months after the end of perioperative chemotherapy or adjuvant chemotherapy (counting from the end of the combined regimen);
* Have not received taxane-based therapy previously;
* Have at least one measurable lesion (meeting RECIST v1.1 criteria);
* The functions of important organs meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment):
Absolute neutrophil count ≥ 1.5×109/L, white blood cell count ≥ 3.0×109/L; Platelet count ≥ 90×109/L; Hemoglobin ≥ 8g/dL; Total bilirubin (TBIL) ≤ 1.5×ULN; ALT and AST ≤ 2.5×ULN; BUN and creatinine (Cr) ≤ 1.5×ULN (and creatinine clearance (CCr) ≥ 50mL/min); Left ventricular ejection fraction (LVEF) ≥ 50%; Fridericia-corrected QT interval (QTcF) \< 470 millis…
What they're measuring
1
objective response rate
Timeframe: the duration from the date of randomization to any documented tumor progression or death due to any cause, assessed up to 12 months