Gastric CancerGRACE-DENCT07882212
GRACE-DE: Prospective Multicenter Real-world Gastric Cancer Patients Starting AZ-developed and Approved Drugs in Germany (Umbrella Study)
An observational study of Gastric Cancer and Gastroesophageal Junction Cancer, run by AstraZeneca.
Trial summary
This is a prospective, non-interventional, observational, multicentre study evaluating the real-world effectiveness and safety of AstraZeneca-developed and approved medicines used to treat gastric and/or oesophageal cancers in Germany. Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Cancer
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 30 Sep 2031
- Phase
- Observational
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 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with histologically confirmed of resectable adenocarcinoma of the stomach or of the gastroesophageal junction (GC/GEJC) with the decision to start perioperative treatment with D-FLOT according to marketing authorization being specified within the summary of product characteristics (SmPC) in routine clinical practice in Germany. (Modul A)
Who may be able to join
- Age ≥18 years at the time of enrolment
- Patient is able to read and understand either German or English
- Histologically or cytologically proven resectable adenocarcinoma of the stomach or of the gastroesophageal junction (GC/GEJC) and decision to start perioperative treatment with durvalumab and FLOT chemotherapy (D-FLOT), followed by adjuvant durvalumab as monotherapy, according to its marketing authorization (SmPC). Inclusion can also take place after the 1st dose of perioperative D-FLOT but no later than 4 weeks after treatment initiation. (Modul A)
- Treatment decision was made independently from study participation
- Provision of signed and dated written informed consent to participate in the study
Who cannot join
- Current active and already planned participation in an interventional clinical trial for stomach and/or esophageal cancer.
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: Prospective, Observational, Multicenter, and Multicohort Study of Patients With Gastric Cancer Initiating AstraZeneca-developed and Approved Drugs in Germany GastRic CAnCEr Real-World Evidence Germany (Umbrella Study)
This is a prospective, non-interventional, observational, multicentre study evaluating the real-world effectiveness and safety of AstraZeneca-developed and approved medicines used to treat gastric and/or oesophageal cancers in Germany. The study is designed as an umbrella study comprising several drug- and indication-specific modules. The present description covers Module A, which evaluates durvalumab used perioperatively in combination with FLOT chemotherapy (D-FLOT), followed by adjuvant durvalumab monotherapy in adults with resectable gastric or gastro-oesophageal junction adenocarcinoma in routine clinical practice in Germany.
Read the detailed description
Eligible participants in Module A will be adult patients with histologically or cytologically confirmed, resectable adenocarcinoma of the stomach or gastroesophageal junction who have a documented decision to initiate perioperative treatment with durvalumab in combination with FLOT chemotherapy (D-FLOT), followed by adjuvant durvalumab monotherapy where applicable, in accordance with the applicable Summary of Product Characteristics (SmPC) and routine clinical practice in Germany. The decision to initiate D-FLOT must be made independently of study participation. Initiation of treatment with durvalumab and FLOT is an eligibility criterion for the study.
All diagnostic and treatment procedures, including the type and timing of surgery, treatment modifications and the frequency of routine clinical visits, will be at the discretion of the treating physician and will not be defined by the study protocol. No additional diagnostic or therapeutic procedures are mandated by the study. Data will be collected from medical records generated during routine clinical care and entered into the electronic case report form.
Approximately 300 eligible participants will be enrolled throughout Germany. Participants will be followed from initiation of perioperative D-FLOT for up to 36 months, or until death, withdrawal of informed consent, loss to follow-up, participation in an interventional clinical trial or initiation of subsequent systemic treatment for gastric or gastroesophageal junction cancer, whichever occurs first.
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- Keywords
- Durvalumab, Fluorouracil, Leucovorin, Oxaliplatin, Docetaxel, D-FLOT
- Medical subject headings
- Stomach Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world Event-free Survival at 24 Months (rwEFS24)
rwEFS24 is defined as the proportion of participants who are alive and event-free 24 months after initiation of perioperative D-FLOT. Real-world event-free survival is measured from the first dose of durvalumab in combination with FLOT until the first occurrence of disease progression during neoadjuvant treatment that precludes surgery or requires treatment other than D-FLOT, disease progression or recurrence during or after surgery, or death from any cause. Disease progression and recurrence will be assessed by the treating physician based on information available from routine clinical care. The outcome will be analysed using the Kaplan-Meier method in the Full Analysis Set. (Modul A)
Measured: From the first dose of perioperative D-FLOT until 24 months after treatment initiation. (Modul A)
Secondary outcomes (6)
Baseline demographic, clinical and disease characteristics
Demographic, clinical and disease characteristics of participants receiving perioperative durvalumab plus FLOT will be described. Variables may include age, sex, ECOG performance status, comorbidities, Helicobacter pylori status, tumour histology, tumour localisation, clinical tumour stage and available biomarker results, including PD-L1, HER2, Claudin 18.2, MSI and MMR status. Continuous and categorical variables will be summarised descriptively, including the number of missing values. (Modul A)
Measured: At baseline, before or at initiation of perioperative D-FLOT. (Modul A)
Proportion of participants reaching subsequent treatment phases
The proportion of participants reaching subsequent treatment phases will be described, including surgical resection, initiation of any adjuvant treatment, initiation of adjuvant durvalumab plus FLOT, and initiation of durvalumab monotherapy after adjuvant treatment. The number and percentage of participants reaching each treatment phase will be reported with appropriate confidence intervals. (Modul A)
Measured: From initiation of perioperative D-FLOT until the end of the observation period, up to 36 months. (Modul A)
Pathological Complete Response Rate (pCR) (Modul A)
Pathological complete response is defined as the absence of detectable residual viable tumour cells in the primary tumour and resected lymph nodes at surgery, corresponding to tumour regression score 0 according to the local pathology assessment. The number and percentage of participants achieving a pathological complete response will be described. The pathological tumour regression score distribution may also be summarised where available.
Measured: At surgery, approximately 8-12 weeks after initiation of perioperative D-FLOT, where applicable.
Completeness of surgical resection: R0, R1 and R2 resection rates (Modul A)
Completeness of resection will be described among participants who undergo surgical resection. R0 is defined as complete resection with negative margins, R1 as grossly complete resection with microscopically positive margins, and R2 as incomplete resection with macroscopically positive margins. The number and percentage of participants with R0, R1 and R2 resection will be reported. The proportions with R0 and R0/R1 resection may also be presented with appropriate confidence intervals.
Measured: At surgery and the first post-surgery assessment, approximately 8-12 weeks after initiation of perioperative D-FLOT, where applicable.
Real-world Overall Survival (rwOS)
rwOS is defined as the time from the first dose of perioperative D-FLOT, consisting of durvalumab in combination with FLOT chemotherapy, until death from any cause. The proportions of participants alive at 6, 18, 24 and 36 months after treatment initiation will be estimated using the Kaplan-Meier method and presented with appropriate 95% confidence intervals. Participants without a documented death will be censored at the last date they were known to be alive. Cause of death may be described as disease-related, treatment-related, other or unknown, where information is available. (Modul A)
Measured: From the first dose of perioperative D-FLOT until death or up to 36 months after treatment initiation. (Modul A)
Safety: Collection of Adverse Events (AE)
Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Sep 2031 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882212
- Sponsor's protocol ID
- D133HR00069
- Acronym
- GRACE-DE
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request 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.