Disitamab Vedotin Combined With Fruquintinib and Tislelizumab in Second-line Treatment for HER2-positive Metastatic Gastric Cancer: A Prospective Phase Ib/II Study
At present, there is no anti-HER2 therapy recommended by guidelines for second-line treatment of advanced gastric cancer with HER2-positive or HER2-overexpression, and combined with anti-angiogenic drugs are mainly used. Disitamab Vedotin is an anti-HER2 ADC, and its cytotoxic drugs are also anti-microtubule formation as the main mechanism of drugs. Fruquintinib is an anti-vascular TKI drug. In addition, according to the results of KEYNOTE-811, patients with HER2-positive advanced gastric cancer benefit significantly from immunotherapy, so the investigators hope to explore the possibility of immunotherapy in second-line treatment of HER2-positive advanced gastric cancer. Therefore, the study plans to enroll HER2-positive patients who have failed first-line therapy and explore the efficacy of the regimen of Disitamab Vedotin combined with fruquintinib combined with Tislezumab in second-line therapy.
• older than18 years of age, gender not limited;
• the histologic diagnosis of the stomach or gastroesophageal junction adenocarcinoma;
• immunohistochemical HER2 2 + 3 + or HER2, FISH is positive;
• at least have a measurable lesions (10 mm or higher spiral CT scan, RECIST 1.1 standard);
• First-line treatment failure of fluorouracil and the platinum, or to accept containing fluorouracil and platinum adjuvant chemotherapy in patients with recurrence after 6 months;
• ECOG 0-2, expected survival for 3 months or more;
• the subjects treated with other damage has been restored, accepting radiotherapy should be ended more than 3 weeks;
• major organs function is normal, the group within 1 week before the lab test results meet the following criteria: (1) The standard of blood routine examination shall meet:
‣ HB≥80g/L;
⁃ ANC ≥1.5×109/L;
⁃ PLT ≥75×109/L (2) Biochemical examination shall meet the following standards:
• a. Total bilirubin BIL \< 1.25 \* upper limit of normal (ULN) B. the ALT and AST acuities were 2.5 \* ULN. C. serum creatinine (Cr) of 1.5 or less \* ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft - Gault formula)
• participants voluntarily participate in this study, and signed by himself or agent informed consent; Patient compliance is good, can cooperate with the relevant examination, treatment and follow-up.