DURATION-GC: FLOT Plus Durvalumab and TS-1 Plus Durvalumab for Resectable Gastric Cancer

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTaipei Veterans General Hospital, Taiwan

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Durvalumab, TS-1

Treatment groups

35 Participants
are divided into 1 treatment group