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

NCT07757191 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-06-003A
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resectable Gasrtic Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  From enrollment to the end of surgical treatment.

• 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.

  From the start of adjuvant treatment to the end of adjuvant treatment up to 90 days.

• Safety of Adjuvant Therapy

  Incidence and severity of the treatment emergent adverse events of the adjuvant therapy (per NCI-CTCAE 5.0).

  From the start of adjuvant treatment to the end of adjuvant treatment up to 90 days.

Secondary Outcomes (2)

• Overall survival

  From enrollment to the end of treatment up to 3 years.

• Event free survival

  From the start of adjuvant treatment to the end of adjuvant treatment up to 3 years.

Study Arms (1)

Treatment arm

EXPERIMENTAL

Drug: Durvalumab, TS-1

Interventions

Durvalumab, TS-1 DRUG

This 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.

Treatment arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• a. Per the judgment of the Investigator, patient must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.
• 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:
• Hemoglobin ≥9.0 g/dL
• Absolute neutrophil count ≥1.0 × 109 /L
• Platelet count ≥100 × 109/L
• Serum bilirubin ≤1.5 × the institutional upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
• ALT and AST ≤2.5 × ULN
• Measured creatinine clearance (CL) \>40 mL/min, as measured by a 24-hour urine collection or calculated creatinine CL\>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976).

You may not qualify if:

• 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
• History of another primary malignancy except for
• Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of investigational product (IP) and of low potential risk for recurrence
• Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
• Adequately treated carcinoma in situ without evidence of disease
• History of active primary immunodeficiency
• Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice). Patients with HBV infection under anti-HBV drugs are eligible. Patients positive for hepatitis C (HCV) antibody are eligible if polymerase chain reaction is negative for HCV RNA.
• Known to have tested positive for human immunodeficiency virus (HIV) (positive HIV 1/2 antibodies).

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan

Location

MeSH Terms

Interventions

durvalumab; titanium silicide

Study Officials

• Ming-Huang Chen

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

+886228712121; lweisiou@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): October 1, 2029
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)