A Phase 3 interventional study of FLOT Chemotherapy and Durvalumab in Gastric and Esophagogastric Junction, sponsored by AstraZeneca. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
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).
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.
AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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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Exclusion Criteria:
-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
(a) 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.
Durvalumab +FLOT followed by durvalumab
Drug: FLOT Chemotherapy · Drug: Durvalumab
Placebo +FLOT followed by Placebo
Drug: FLOT Chemotherapy
Drug pages: Fluorouracil · Leucovorin · Oxaliplatin · Docetaxel
A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
Human monoclonal antibody
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.
Time frame: Up to 24 months after the last participant is randomized
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.
Time frame: 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.
Time frame: 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: 1. Progression that precludes surgery or requires non-protocol therapy, 2. Local or distant recurrence or progression of disease, or 3) Death due to any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 months after the last participant is randomized
To assess the safety and tolerability of Arm A as compared to Arm B in participants with GC/GEJC
Safety and tolerability will be evaluated in terms of adverse events (AEs)
Time frame: Up to 24 months after the last participant is randomized
No study locations are listed for this record.
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Nov 2029, 35 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Durvalumab