Phase II Clinical Study of Adebrelimab and Fruquintinib Combined With Paclitaxel/Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer After First-line Treatment With PD-1 Antibody Failed
This is a prospective, single-center, open, single-arm clinical study to observe and evaluate the efficacy and safety of Fruquintinib and Adebrelimab combined with paclitaxel/albumin paclitaxel for second-line treatment of advanced gastric cancer.
• Age ≥18 years old.
• The ECOG score is 0-1 and does not deteriorate within 7 days.
• Patients with histologically confirmed, metastatic, or unresectable locally advanced gastric cancer or GEJ adenocarcinoma.
• Previously received one systemic chemotherapy regimen for this cancer and progressed; Or have received adjuvant chemotherapy, but have disease progression or recurrence within 6 months after the end of treatment.
• First-line exposure to PD-1 antibodies and first-line treatment of PFS greater than 9 months.
• Measurable lesions that meet RECIST 1.1 criteria.
• Have adequate organ and bone marrow function, laboratory tests meet the following requirements:
∙ HGB≥90g/L;
‣ NEUT≥1.5×10\^9/L;
‣ PLT ≥80×10\^9/L;
‣ TBIL≤1.5 times upper limit of normal value (ULN);
‣ ALT and AST≤2.5 x ULN; In liver metastasis, ALT and AST≤5×ULN;
‣ Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
‣ Urinary protein \< (++), or 24-hour urinary protein volume \< 1.0 g.
• Normal coagulation function, no active bleeding
∙ International standardized ratio INR≤1.5;
‣ Partial thromboplastin time APTT≤1.5 ULN.
• Women of childbearing age must undergo a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last dose of the study drug; For men, they should be surgically sterilized or consent to an appropriate method of contraception during the observation period and for 8 weeks after the last administration of the study drug.
⁃ Expected survival ≥3 months.
⁃ Patients voluntarily joined the study and signed an informed consent form (ICF).
⁃ It is expected that the compliance is good, and the efficacy and adverse reactions can be followed up according to the protocol requirements.