EUCTR2019-001555-40-DK
Active, not recruiting
Phase 1
A Randomized, Double-blind, Placebo-controlled, Phase III Study of Neoadjuvant-Adjuvant Durvalumab and FLOT Chemotherapy Followed by Adjuvant Durvalumab or Placebo in Patients with Resectable Gastric and Gastroesophageal Cancer (GC/GEJC) (MATTERHORN) - MATTERHOR
ConditionsHistologically documented gastric or gastroesophageal junction adenocarcinoma withresectable disease (Stage II or higher per AJCC 8th edition).MedDRA version: 21.1Level: PTClassification code 10017758Term: Gastric cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10066354Term: Adenocarcinoma of the gastroesophageal junctionSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Histologically documented gastric or gastroesophageal junction adenocarcinoma withresectable disease (Stage II or higher per AJCC 8th edition).
- Sponsor
- AstraZeneca AB
- Enrollment
- 900
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with histologically documented gastric or gastroesophageal junction adenocarcinoma with resectable disease (Stage II or higher per AJCC 8th edition).
- •Patients must have undergo radical surgery.
- •No prior anti\-cancer therapy for the current malignancy.
- •World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
- •Adequate organ and marrow function
- •Availability of tumor sample prior to study entry
- •Must have a life expectancy of at least 24 weeks
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
Exclusion Criteria
- •Patients with peritoneal dissemination or distant metastasis
- •Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor
- •History of allogeneic organ transplantation.
- •Contra\-indication to any of the study drugs
- •Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
Outcomes
Primary Outcomes
Not specified
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