DURATION-GC: FLOT Plus Durvalumab and TS-1 Plus Durvalumab for Resectable Gastric Cancer (NCT07757191) | Clinical Trial Compass
Not Yet RecruitingPhase 2
DURATION-GC: FLOT Plus Durvalumab and TS-1 Plus Durvalumab for Resectable Gastric Cancer
Taiwan35 participantsStarted 2026-09
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (cT2/3N+ or T4Nany tumors with M0 per AJCC 8th edition). GEJC includes Siewert\* type 2 and 3 tumor. Siewert\* type 1 tumor is also eligible as long as the patient is intended to be treated in the same way as for Siewert type 2 and 3 tumors.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pathological complete response (pCR) rate
Timeframe: From enrollment to the end of surgical treatment.
2
Completion rate of Adjuvant Therapy
Timeframe: From the start of adjuvant treatment to the end of adjuvant treatment up to 90 days.
3
Safety of Adjuvant Therapy
Timeframe: From the start of adjuvant treatment to the end of adjuvant treatment up to 90 days.
. World Health Organization (WHO)/ECOG performance status (PS) of 0 or 1 at enrollment
. No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy.
. Adequate organ and marrow function as defined below:
Exclusion criteria
. 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.
. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
. Patients with vitiligo or alopecia
. Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
. Any chronic skin condition that does not require systemic therapy
. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic GI conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the patient to give written informed consent