About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
HER2-positive gastric or gastroesophageal junction adenocarcinoma.
Conditions that may significantly affect oral drug absorption, including inability to swallow, persistent nausea or vomiting, chronic diarrhea, or intestinal obstruction.
Known hypersensitivity or allergy to adebrelimab, apatinib, oxaliplatin, S-1 (tegafur/gimeracil/oteracil), or any of their excipients.
History of severe allergic reactions to monoclonal antibodies.
Trial design
Treatments tested in this trial
- Adebrelimab
- Apatinib
- SOX Chemotherapy