← Back to Search

Monoclonal Antibodies

Durvalumab + FLOT for Gastric Cancer

São Paulo, Brazil
Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must undergo radical surgery.
World Health Organization (WHO)/ECOG performance status of 0 or 1 at enrollment.
Must not have
Patients with adenosquamous cell carcinoma, squamous cell carcinoma, or GI stromal tumor.
History of allogeneic organ transplantation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Pivotal Trial

Summary

This trial is testing whether adding durvalumab to a standard chemotherapy mix around the time of surgery can help patients with stomach or gastroesophageal cancer. Durvalumab helps the immune system fight cancer, while the chemotherapy drugs kill cancer cells.

See full description
Who is the study for?
This trial is for patients with resectable gastric or gastroesophageal junction adenocarcinoma, who haven't had cancer treatment before. They must be in good physical condition (WHO/ECOG status 0 or 1), have a life expectancy of at least 24 weeks, and adequate organ function. Those on recent immunosuppressants, with certain contraindications, metastasis, non-adenocarcinoma cancers, or an organ transplant history can't join.Check my eligibility
What is being tested?
The study tests Durvalumab (an immunotherapy drug) combined with FLOT chemotherapy against a placebo plus FLOT chemotherapy in patients undergoing surgery for their cancer. It's designed to see if adding Durvalumab before and after surgery can improve outcomes.See study design
What are the potential side effects?
Durvalumab may cause immune-related side effects like inflammation in various organs, infusion reactions similar to allergic responses, fatigue and infections. FLOT chemotherapy could lead to nausea, hair loss, low blood cell counts increasing infection risk and bleeding problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I will have a major surgery to remove my cancer.
 show original
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
 show original
Select...
My stomach cancer is operable and at least stage II.
 show original
Select...
I have not received any treatment for my current cancer.
 show original

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is either adenosquamous, squamous cell, or a GI stromal tumor.
 show original
Select...
I have received an organ transplant from another person.
 show original
Select...
My cancer has spread to the lining of my abdomen or other distant parts.
 show original
Select...
I am not allergic or intolerant to the drugs used in this study.
 show original

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-free survival (EFS)
Secondary study objectives
To compare Arm A relative to Arm B on overall survival (OS)
To compare Arm A relative to Arm B on pathological complete response (pCR) rate

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm AExperimental Treatment2 Interventions
Durvalumab and FLOT chemotherapy
Group II: Arm BPlacebo Group1 Intervention
placebo product and FLOT chemotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
2017
Completed Phase 4
~3890

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for gastrointestinal tumors include immune checkpoint inhibitors like Durvalumab, which block the PD-L1 pathway, allowing the immune system to better recognize and attack cancer cells. HER2 inhibitors, such as trastuzumab, target the HER2 protein overexpressed in some tumors, inhibiting cell proliferation. VEGF inhibitors like ramucirumab block the vascular endothelial growth factor, reducing tumor blood supply and growth. These targeted therapies are crucial for gastrointestinal tumor patients as they offer more personalized and effective treatment options, potentially leading to better clinical outcomes.
Recurrent glioma clinical trial, CheckMate-143: the game is not over yet.Neoadjuvant treatment of locally advanced esophageal and junctional cancer: the evidence-base, current key questions and clinical trials.

Find a Location

Closest Location:Research Site· Fairfax, VA

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,449 Previous Clinical Trials
289,175,128 Total Patients Enrolled

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04592913 — Phase 3
Gastrointestinal Cancer Research Study Groups: Arm B, Arm A
Gastrointestinal Cancer Clinical Trial 2023: Durvalumab Highlights & Side Effects. Trial Name: NCT04592913 — Phase 3
Durvalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04592913 — Phase 3
~130 spots leftby Oct 2025