GastricPhase 3NCT07877818
A Study of Neoadjuvant-adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable GC/GEJC.
A Phase 3 study testing FLOT Chemotherapy and Durvalumab in people with Gastric and Esophagogastric Junction, run by AstraZeneca.
Trial summary
This study aims to assess the efficacy and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to placebo in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric, Esophagogastric Junction
- What is being tested?
- FLOT Chemotherapy and Durvalumab
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2026to 1 Nov 2029
- Phase
- Phase 3
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
- 1. Capable of giving signed informed consent. 2. Male and/or Female, Age ≥ 18 years at the time of screening. 3. Histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease, GEJC includes Siewert* type 2 and 3 tumour and Siewert* type 1 tumour.
- Per the judgment of the Investigator, participants must be medically fit for treatment with neoadjuvant FLOT therapy prior to radical surgery.
- At screening, complete surgical resection of the primary GC/GEJC must be deemed achievable, as assessed by a multidisciplinary evaluation, which must include a board certified GI surgeon.
- No prior anti-cancer therapy (eg, chemotherapy, radiation therapy, or chemoradiation therapy) for the current malignancy.
- 4. ECOG PS of 0 or 1 with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
- 5. Adequate organ and marrow function as defined below:
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- Haemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1.5 × 109/L
- Platelet count ≥ 100 × 109/L
- Serum bilirubin ≤ 1.5 ×ULN. This will not apply to participants with confirmed Gilbert's syndrome, who will be allowed in consultation with their physician.
- ALT and AST ≤ 2.5 × ULN
- Measured CL > 50 mL/min or Calculated CL > 50 mL/min as determined by Cockcroft-Gault (using actual body weight) 6. Must have a life expectancy of at least 24 weeks. 7. Body weight > 30 kg at enrolment and randomization. 8. Meeting tumour sample requirements (at screening) to confirm PD-L1 status.
Who cannot join
- -1. Participants with peritoneal dissemination (including tumour cells in peritoneal fluid) or distant metastasis.
- 2. Participants with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumour.
- 3. History of allogeneic organ transplantation. 4. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], systemic lupus erythematosus, sarcoidosis, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc), autoimmune pneumonitis, and autoimmune myocarditis.
- 5. Uncontrolled intercurrent illness 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.
- 6. History of another primary malignancy except for
- Malignancy treated with curative intent and with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease (c) Adequately treated carcinoma in situ without evidence of disease 7. History of active primary immunodeficiency. 8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice) and HIV verified by positive HIV-1 or HIV-2 antibodies.
- 9. Mean QTc ≥ 470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).
- 10. Known allergy or hypersensitivity to any of the study interventions or any of the study intervention excipients.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab in Chinese Patients With Resectable Gastric and Gastroesophageal Junction Cancer (GC/GEJC) (MATTERHORN-CN).
This study aims to assess the efficacy and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to placebo in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).
Read the detailed description
Informed by the favorable benefit-risk profile demonstrated by the global MATTERHORN study, the current study is designed to assess the efficacy and safety of neoadjuvant-adjuvant durvalumab in combination with FLOT chemotherapy followed by adjuvant durvalumab monotherapy (Arm A), compared with neoadjuvant-adjuvant placebo in combination with FLOT chemotherapy followed by adjuvant placebo monotherapy (Arm B) in Chinese participants with resectable GC/GEJC. Approximately 140 participants will be randomized to either Arm A or Arm B.
- Conditions
- Gastric, Esophagogastric Junction
- Being tested
- FLOT Chemotherapy, Durvalumab
- Keywords
- Durvalumab, FLOT chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FLOT ChemotherapyDrug
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
DurvalumabDrug
Human monoclonal antibody
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Durvalumab +FLOT followed by durvalumab Receives: Drug: FLOT Chemotherapy; Drug: Durvalumab |
| Arm B | Placebo comparator | Placebo +FLOT followed by Placebo Receives: Drug: FLOT Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare Arm A relative to Arm B on pCR rate
pCR rate is defined as the proportion of participants who have no residual viable tumour in the resected specimens and as determined by central pathology review.
Measured: Up to 24 months after the last participant is randomized
Secondary outcomes (6)
To compare Arm A relative to Arm B on event-free survival at 24 months (EFS24)
EFS24 is the proportion of participants alive and event free 24 months after randomization, according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 per Investigator assessment and/or locally by pathology testing.
Measured: Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on overall survival (OS)
Overall survival is length of time from randomization until the date of death due to any cause.
Measured: Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on event-free survival (EFS)
EFS is defined as the time from randomization to the following, according to RECIST 1.1 per Investigator assessment and/or locally by pathology testing:
- Progression that precludes surgery or requires non-protocol therapy,
- Local or distant recurrence or progression of disease, or 3) Death due to any cause.
Measured: Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on the rate of complete resection (R0)
R0 resection (complete resection) rate is the proportion of participants who have a confirmed complete resection as assessed by pathology review.
Measured: Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on metastasis-free survival (MFS) and disease-specific survival (DSS)
MFS is the time from randomization until the development of metastasis using RECIST 1.1 or death due to any cause.
- DSS is the time from randomization untildeath due to GC/GEJC.
Measured: Up to 24 months after the last participant is randomized
To compare Arm A relative to Arm B on disease-free survival (DFS) in participants who undergo R0 resection surgery
DFS is defined as the time from first post-surgery scan until disease recurrence, using RECIST 1.1, or death due to any cause.
Measured: Up to 24 months after the last participant is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start30 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastricStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877818
- Sponsor's protocol ID
- D907JC00001
- Status last verified
- Oct 2026
- First submitted
- 15 Sep 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be sharedQualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared. upon certain conditions.