This study is a prospective, randomized, non-controlled, open-label clinical trial aimed at evaluating the efficacy and safety of adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel, as well as apatinib mesylate combined with albumin-bound paclitaxel, in treating advanced second-line gastric adenocarcinoma or gastroesophageal junction adenocarcinoma.
The study's primary endpoint is median progression-free survival (mPFS), and it plans to enroll 50 patients with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma who failed first-line systemic therapy.
This is a randomized, non-controlled, open-label trial. Eligible participants will be randomly assigned in a 1:1 ratio to receive either adebrelimab combined with apatinib mesylate and albumin-bound paclitaxel (Cohort 1) or apatinib mesylate combined with albumin-bound paclitaxel (Cohort 2).
The screening phase is 28 days. After completing screening tests and assessments, eligible participants will be randomly assigned to the following treatments:
Cohort 1:
* Adebrelimab: 1200 mg, IV infusion, once every 21 days, until PD or intolerance, maximum use 2 years; * Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years; * Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles.
Cohort 2:
* Apatinib mesylate: 250 mg, orally, once daily, days 1-21; until PD or intolerance, maximum use 2 years; * Albumin-bound paclitaxel: 200-260 mg/m², IV infusion, day 1, once every 21 days, for 4-6 cycles.
Fully understand this study and voluntarily sign the informed consent form, with good compliance and cooperation during follow-up;
Age ≥18 years and ≤80 years;
ECOG score 0-1;
Histologically or cytologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma, locally advanced and unresectable, with local recurrence or distant metastasis;
Those allergic to therapeutic drugs or those who have received first-line investigational drug treatment;
Patients who have received first-line VEGFR inhibitor therapy, such as sorafenib, sunitinib, apatinib, etc.; Patients who have received first-line paclitaxel drugs.
(1) Have received any investigational drug within 4 weeks prior to first use; (2) Subjects who require systemic corticosteroids (> 10 mg prednisone equivalent daily) or other immunosuppressants within 2 weeks prior to first use of the study drug, excluding cases of corticosteroid use targeting local esophageal inflammation and preventing allergies, nausea, and vomiting. (3) Other special circumstances require communication with the sponsor. In the absence of active autoimmune disease, inhaled or topical corticosteroids and adrenal corticosteroid replacement doses > 10 mg/day of prednisone are permitted; (4) Those who have received anti-tumor vaccines or received live vaccines within 4 weeks prior to the first administration of the study drug;
Having any active autoimmune disease or a history of autoimmune diseases (such as interstitial lung).
Parallel
Adebrelimab
DrugAdebrelimab：1200mg, IV infusion, given once every 21 days, until PD or intolerance, for up to 2 years;
Apatinib
DrugApatinib：250mg, taken orally, once a day, days 1-21; continue until PD or intolerance, up to a maximum of 2 years;
Albumin-bound paclitaxel
DrugAlbumin-bound paclitaxel：200-260 mg/m², intravenous infusion, on day 1, given once every 21 days, for 4-6 cycles.
Median progression-free survival
Median overall survival
Objective response rate
Duration of Response
Adverse event rate
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