Phase II Clinical Study of Adebrelimab Plus Apatinib and SOX Regimen for Conversion Therapy of Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
This is a prospective, single-center, single-arm, open phase II clinical study. Forty-nine participants with pathologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer are scheduled to be enrolled in this study. All participants will be treated with 2 to 8 cycles of adebrelimab, apatinib, oxaliplatin, and tigio before surgery. Participants will evaluate the treatment effect after every 2 cycles of medication. By the investigator assessment as an operable subject, apatinib was discontinued for one cycle. The adjuvant treatment will be determined by the investigators based on the participants' postoperative pathology results. Participants requiring adjuvant therapy, with a postoperative interval of at least 4 weeks, but not more than 10 weeks. When the resection standard isn't met for 8 cycles of treatment, the treatment is switched to a maintenance phase, which the subject treatment regimen is determined by the investigator. During the treatment period, participants will receive the study drugs on Day 1 of each 21-day cycle until evidence of disease progression or unacceptable toxicity.
• Age 18-75 years at the time of enrollment, with an estimated life expectancy of ≥ 3 months.
• Histologically or cytologically confirmed gastric cancer or gastroesophageal junction cancer, predominantly adenocarcinoma.
• Unresectable locally advanced gastric or gastroesophageal junction adenocarcinoma (Stage III or IV), as determined by the investigator based on CT, MRI, and/or PET-CT.
• Disease with conversion (translational) therapeutic potential, as assessed by the investigator.
• No prior anti-tumor treatment, including chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic anticancer therapies.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate hematologic function within 14 days prior to enrollment:
‣ White blood cell count ≥ 3.5 × 10⁹/L.
⁃ Absolute neutrophil count ≥ 1.5 × 10⁹/L.
⁃ Hemoglobin ≥ 90 g/L (9.0 g/dL).
⁃ Platelet count ≥ 100 × 10⁹/L.
⁃ Adequate hepatic function within 14 days prior to enrollment:Total bilirubin ≤ 1.5 × upper limit of normal (ULN);ALT and AST ≤ 2.5 × ULN in patients without liver metastases;ALT and AST ≤ 5 × ULN in patients with liver metastases;Adequate renal function:Serum creatinine ≤ 1.5 × ULN;Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and agree to use effective contraception during the study and for at least 12 weeks after the last dose.
• Male participants must be surgically sterile or agree to use effective contraception during the study and for at least 12 weeks after the last dose
• Ability to understand and willingness to sign a written informed consent form
• Expected to comply with study procedures and follow-up requirements