Actively Recruiting
Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ Adenocarcinoma
Led by Fudan University · Updated on 2026-02-05
250
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Albumin-bound Paclitaxel-based Second-line Treatment Regimens for Locally Advanced or Metastatic G/GEJ Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully understand this study and voluntarily sign the informed consent form
- Between 18 and 80 years old (inclusive), male or female
- Diagnosis of unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by pathology or histology
- ECOG performance status of 0 to 2
- Known HER2 negative status
- Expected survival of at least 3 months
- Disease progression after first-line fluoropyrimidine-platinum chemotherapy combined with PD-1/PD-L1 monoclonal antibody, or progression during maintenance treatment; or progression within 6 months after perioperative or adjuvant chemotherapy
- No prior taxane-based therapy
- At least one measurable lesion meeting RECIST v1.1 criteria
- Adequate organ function with laboratory values meeting specified limits (including blood counts, liver and kidney function, heart function, coagulation, and thyroid function)
- Negative pregnancy test for premenopausal women and women within 1 year postmenopause before treatment
You will not qualify if you...
- History of other malignancies within 5 years, except treated skin basal cell or squamous cell carcinoma or cervical carcinoma in situ
- Prior allogeneic bone marrow or organ transplantation
- Severe cardiovascular disease within 6 months, including unstable angina or myocardial infarction
- Allergies to study drugs or their components
- Uncontrolled hypertension (systolic 6 150 mmHg or diastolic 6 90 mmHg)
- Conditions affecting drug absorption or inability to take oral medication
- Active ulcers or digestive tract diseases that may cause bleeding or perforation
- Recent significant bleeding or thromboembolic events
- Significant clinical cardiovascular diseases including heart failure NYHA > 2, arrhythmias, or LVEF < 50%
- Active or uncontrolled severe infections
- Known HIV infection or active viral hepatitis infection
- Active or history of autoimmune diseases except certain controlled conditions
- Recent use of immunosuppressants or systemic hormone therapy
- Interstitial lung disease, pneumonia, pulmonary fibrosis, acute lung disease, or radiation pneumonitis
- Pregnant or lactating women
- Other significant diseases or abnormalities judged unsuitable by the investigator
- Significant proteinuria
- Investigator judgment of unsuitability for the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wanjing Feng
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
W
Wanjing Feng
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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