To address regional disparity, the investigators propose a tailored perioperative strategy for East Asian patients, combining neoadjuvant FLOT plus durvalumab, followed by adjuvant TS-1 plus durvalumab. This approach seeks to balance efficacy, immunologic synergy, and treatment tolerability, offering a more practical regimen for Eastern populations.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow-up visits.
Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
Age ≥18 years at the time of screening.
Patients with peritoneal dissemination (including tumor cells in peritoneal fluid) or distant metastasis
Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor
History of allogeneic organ transplantation.
Patients with vitiligo or alopecia
Single group
Durvalumab, TS-1
DrugThis is a single-arm, open-label, single center, Phase phase II study to assess the efficacy and safety of neoadjuvant FLOT chemotherapy plus Durvalumab followed by adjuvant durvalumab in combination with TS1 in patients with resectable locally advnaced GC/GEJC.
Pathological complete response (pCR) rate
Pathological complete response (pCR) was selected as the primary endpoint to enable a feasible sample size and to specifically capture the antitumor activity of the neoadjuvant immunochemotherapy backbone. While the study hypothesis extends beyond neoadjuvant efficacy to include postoperative tolerability and feasibility, these aspects are addressed through predefined secondary endpoints focusing on safety, treatment completion, and postoperative outcomes.
Completion rate of Adjuvant Therapy
Duration of adjuvant therapy, defined as the time from initiation to permanent discontinuation of adjuvant treatment for any reason. Adjuvant treatment completion rate, defined as the proportion of patients who complete all planned cycles of adjuvant durvalumab plus TS-1 per protocol.
Safety of Adjuvant Therapy
Incidence and severity of the treatment emergent adverse events of the adjuvant therapy (per NCI-CTCAE 5.0).
Overall survival
Overall survival is length of time from treatment until the date of death due to any cause.
Event free survival
Event-free survival (EFS) is defined as the time from first dose of study treatment to the first occurrence of any of the following events, whichever occurs first: (1) Disease progression that precludes curative surgery or requires non-protocol therapy during neoadjuvant treatment (per RECIST 1.1); (2) Pathologically or radiologically confirmed local or distant recurrence after surgery; (3) Death from any cause.
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