Trial · NCT07882212
GRACE-DE: Prospective Multicenter Real-world Gastric Cancer Patients Starting AZ-developed and Approved Drugs in Germany (Umbrella Study)
NCT07882212, Not yet recruiting, AstraZeneca
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. GRACE-DE: Prospective Multicenter Real-world Gastric Cancer Patients Starting AZ-developed and Approved Drugs in Germany (Umbrella Study). Trials, record NCT07882212. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07882212
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- GRACE-DE: Prospective Multicenter Real-world Gastric Cancer Patients Starting AZ-developed and Approved Drugs in Germany (Umbrella Study)
- NCT number
- NCT07882212
- Status
- Not yet recruiting
- Enrollment
- 300 participants, estimated
- Lead sponsor
- AstraZeneca
- Conditions
- Gastric Cancer, Gastroesophageal Junction Cancer
- First posted
- 2026-10-20
- Last updated
- 2026-10-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Real-world Event-free Survival at 24 Months (rwEFS24) | From the first dose of perioperative D-FLOT until 24 months after treatment initiation. (Modul A) | 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) |
| Secondary | Baseline demographic, clinical and disease characteristics | At baseline, before or at initiation of perioperative D-FLOT. (Modul A) | 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) |
| Secondary | Proportion of participants reaching subsequent treatment phases | From initiation of perioperative D-FLOT until the end of the observation period, up to 36 months. (Modul A) | 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) |
| Secondary | Pathological Complete Response Rate (pCR) (Modul A) | At surgery, approximately 8-12 weeks after initiation of perioperative D-FLOT, where applicable. | 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. |
| Secondary | Completeness of surgical resection: R0, R1 and R2 resection rates (Modul A) | At surgery and the first post-surgery assessment, approximately 8-12 weeks after initiation of perioperative D-FLOT, where applicable. | 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. |
| Secondary | Real-world Overall Survival (rwOS) | From the first dose of perioperative D-FLOT until death or up to 36 months after treatment initiation. (Modul A) | 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) |
| Secondary | Safety: Collection of Adverse Events (AE) | up to 36 months | Safety evaluated based on type of Adverse Event (AE), intensity, causal relationship to treatment, duration, handling, outcome, and seriousness. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07882212
GET https://conductscience.org/api/trials/v1/NCT07882212/registered