Phase 3: testing FLOT Chemotherapy for Gastric
This study aims to assess the how well it works and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to dummy treatment (placebo) in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).
Official registry: https://clinicaltrials.gov/study/NCT07877818 · AstraZeneca · enrollment listed as 140
What this phase means
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are FLOT Chemotherapy, or Durvalumab. The registry lists allocation as randomized. This study aims to assess the how well it works and safety of neoadjuvant adjuvant treatment with durvalumab in combination with FLOT compared to dummy treatment (placebo) in combination with FLOT in Chinese patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN-CN).
They plan to enroll about 140 people at 27 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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).
Interventions: FLOT Chemotherapy, Durvalumab
Primary outcome (registry wording): To compare Arm A relative to Arm B on pCR rate
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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:
- Haemoglobin ≥ 9.0 g/dL
- Absolute neutrophil count ≥ 1.5 × 109/L
Who the registry excludes
- 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
- 6\. History of another primary malignancy except for
- 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
Public study contact (from the registry)
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
27 listed- Research Site — Beijing, China (not_yet_recruiting)
- Research Site — Bengbu, China (not_yet_recruiting)
- Research Site — Changchun, China (not_yet_recruiting)
- Research Site — Changsha, China (not_yet_recruiting)
- Research Site — Changzhi, China (not_yet_recruiting)
- Research Site — Chengdu, China (not_yet_recruiting)
- Research Site — Chongqing, China (not_yet_recruiting)
- Research Site — Fuzhou, China (not_yet_recruiting)
- Research Site — Guangzhou, China (not_yet_recruiting)
- Research Site — Hangzhou, China (recruiting)
- Research Site — Hohhot, China (not_yet_recruiting)
- Research Site — Jinan, China (recruiting)
FAQ about this NCT record
Is NCT07877818 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07877818?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07877818?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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