Resectable Gasrtic CancerPhase 2DURATION-GCNCT07757191
DURATION-GC: FLOT Plus Durvalumab and TS-1 Plus Durvalumab for Resectable Gastric Cancer
A Phase 2 study testing Durvalumab, TS-1 in people with Resectable Gasrtic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Resectable Gasrtic Cancer
- What is being tested?
- Durvalumab, TS-1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2026to Oct 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Per the judgment of the Investigator, patient must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.
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- 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).
- Must have a life expectancy of at least 24 weeks
- Body weight >30 kg at enrollment
Who cannot join
- 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
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- 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).
- Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms
- Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
- Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live attenuated vaccines whilst receiving IP and up to 30 days after the last dose of IP.
- Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable.
- Prior immune-mediated therapy including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. The following are exceptions to this criterion:
- Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra articular injection)
- Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
- Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
- Participation in another clinical study with an investigational product within 30 days or 4 weeks, or within 5 half-lives of the investigational product (whichever is longer), prior to the first dose of study treatment.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
- Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of the investigational drugs durvalumab/placebo monotherapy.
- Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taipei Veterans General Hospital
Taipei
Study Coordinator, +886228712121 ext. 65717, lweisiou@gmail.com
Ming-Huang Chen
About this study
Official title: Evaluating the Efficacy and Safety of FLOT Plus Durvalumab as Neoadjuvant Therapy Followed by TS-1 Plus Durvalumab as Adjuvant Therapy in Resectable Gastric Cancer (DURATION-GC)
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.
Read the detailed description
This is a single arm, open label, single center, Phase II study to assess the efficacy and safety of neoadjuvant durvalumab in combination with FLOT chemotherapy followed by adjuvant durvalumab in combination with TS-1 in patients with resectable GC/GEJC (ie, radical-surgery eligible; cT2/3N+ or T4Nany with M0, per AJCC 8th edition).
A total of 28 evaluable subjects will be required for the study. Eligible participants will receive durvalumab 1500 mg on Day 1 + FLOT on Days 1 and 15 Q4W for 2 cycles (2 cycles neoadjuvant, 1 cycle = Q4W in neoadjuvant setting) followed by durvalumab 1500 mg + TS-1 on Day 1 Q3W for 16 additional cycles (1 cycle = Q3W in adjuvant setting).
Neoadjuvant therapy will begin following completion of the screening period, and patients will undergo resection surgery 4 to 8 weeks after the last dose of neoadjuvant therapy. (Surgery >8 weeks after the last dose of neoadjuvant therapy may be permitted in consultation with the PI). Adjuvant therapy will begin 4 to 12 weeks post-surgery (based on the patient's recovery period).
- Conditions
- Resectable Gasrtic Cancer
- Being tested
- Durvalumab, TS-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Durvalumab, TS-1Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: Durvalumab, TS-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: From the start of adjuvant treatment to the end of adjuvant treatment up to 90 days.
Secondary outcomes (2)
Overall survival
Overall survival is length of time from treatment until the date of death due to any cause.
Measured: From enrollment to the end of treatment up to 3 years.
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.
Measured: From the start of adjuvant treatment to the end of adjuvant treatment up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resectable Gasrtic CancerStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ming-Huang Chen, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07757191
- Sponsor's protocol ID
- 2026-06-003A
- Acronym
- DURATION-GC
- Status last verified
- Aug 2026
- First submitted
- 13 Jul 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy and Safety of FLOT Plus Durvalumab as Neoadjuvant Therapy Followed by TS-1 Plus Durvalumab as Adjuvant Therapy in Resectable Gastric Cancer (DURATION-GC)
- ClinicalTrials.gov ID
- NCT07757191
- Acronym / sponsor ID
- DURATION-GC / 2026-06-003A
- Conditions
- Resectable Gasrtic Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a single arm, open label, single center, Phase II study to assess the efficacy and safety of neoadjuvant durvalumab in combination with FLOT chemotherapy followed by adjuvant durvalumab in combination with TS-1 in patients with resectable GC/GEJC (ie, radical-surgery eligible; cT2/3N+ or T4Nany with M0, per AJCC 8th edition).
A total of 28 evaluable subjects will be required for the study. Eligible participants will receive durvalumab 1500 mg on Day 1 + FLOT on Days 1 and 15 Q4W for 2 cycles (2 cycles neoadjuvant, 1 cycle = Q4W in neoadjuvant setting) followed by durvalumab 1500 mg + TS-1 on Day 1 Q3W for 16 additional cycles (1 cycle = Q3W in adjuvant setting).
Neoadjuvant therapy will begin following completion of the screening period, and patients will undergo resection surgery 4 to 8 weeks after the last dose of neoadjuvant therapy. (Surgery >8 weeks after the last dose of neoadjuvant therapy may be permitted in consultation with the PI). Adjuvant therapy will begin 4 to 12 weeks post-surgery (based on the patient's recovery period).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: Durvalumab, TS-1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (29 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Durvalumab, TS-1This 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. | Drug | Treatment arm |
Primary outcome
Pathological complete response (pCR) rate
Time frame: From enrollment to the end of surgical treatment.
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
Time frame: From the start of adjuvant treatment to the end of adjuvant treatment up to 90 days.
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
Time frame: From the start of adjuvant treatment to the end of adjuvant treatment up to 90 days.
Incidence and severity of the treatment emergent adverse events of the adjuvant therapy (per NCI-CTCAE 5.0).
2 secondary outcomes
Overall survival
Time frame: From enrollment to the end of treatment up to 3 years.
Event free survival
Time frame: From the start of adjuvant treatment to the end of adjuvant treatment up to 3 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming-Huang Chen principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Durvalumab, TS-1 in people with Resectable Gasrtic Cancer, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (+886228712121 ext. 65717, lweisiou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response (pCR) rate (time frame: From enrollment to the end of surgical treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026.