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Monoclonal Antibodies

Durvalumab + FLOT for Gastric Cancer

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
Adequate organ and marrow function.
Patients must undergo radical surgery.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying two different combinations of drugs as treatment for resectable gastric cancer.

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
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My organs and bone marrow are working well.
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I will have a major surgery to remove my cancer.
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I am fully active or restricted in physically strenuous activity but can do light work.
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My stomach cancer is operable and at least stage II.
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I have not received any treatment for my current cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
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

Side effects data

From 2022 Phase 3 trial • 867 Patients • NCT03084471
26%
Asthenia
20%
Anaemia
20%
Constipation
17%
Decreased appetite
16%
Diarrhoea
15%
Nausea
13%
Pruritus
10%
Urinary tract infection
10%
Cough
10%
Fatigue
9%
Vomiting
9%
Dyspnoea
9%
Back pain
9%
Oedema peripheral
9%
Pyrexia
7%
Haematuria
7%
Abdominal pain
7%
Arthralgia
7%
Hypothyroidism
6%
Blood creatinine increased
5%
Weight decreased
2%
Sepsis
1%
Pneumonia
1%
Tumour hyperprogression
1%
General physical health deterioration
1%
Death
1%
Acute kidney injury
1%
Pyelonephritis
1%
Device related infection
1%
Urosepsis
1%
Pulmonary embolism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Durvalumab

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 2
~3870

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,238 Previous Clinical Trials
288,448,863 Total Patients Enrolled
1 Trials studying Gastrointestinal Tumors
96 Patients Enrolled for Gastrointestinal Tumors

Media Library

Durvalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04592913 — Phase 3
Gastrointestinal Tumors Research Study Groups: Arm B, Arm A
Gastrointestinal Tumors 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other clinical trials have included FLOT chemotherapy?

"As of now, there are 336 clinical trials running for FLOT chemotherapy. 51 of those live clinical trials are in Phase 3. While the many studies for FLOT chemotherapy are based in Hat Yai, Texas, there are 12872 locations running studies for this treatment."

Answered by AI

Does the age limit for participants in this research project fall below 70 years old?

"This trial is only for patients aged 18 to 200. If you are either under 18 or over 65, don't worry, there are still clinical trials for people in your age bracket. In fact, there are 7 trials for people under 18 and 485 for those over 65."

Answered by AI

What are the ideal characteristics of participants in this research?

"955 participants who currently have esophagogastric junction and are between the ages of 18 and 200 are being recruited for this trial. In addition to meeting the age requirement, participants must also: have resectable disease (Stage II or higher per AJCC 8th edition), undergo radical surgery, have no prior anti-cancer therapy, have a WHO/ECOG performance status of 0 or 1, have adequate organ and marrow function, have a tumor sample available, have a life expectancy of at least 24 weeks."

Answered by AI

What is the U.S. government's stance on FLOT chemotherapy?

"FLOT chemotherapy has gone through multiple Phase 3 trials, so there is a fair amount of data attesting to its efficacy and safety."

Answered by AI

What conditions respond well to FLOT chemotherapy?

"FLOT chemotherapy can offer hope to patients that have unresectable stage iii non-small cell lung cancer that is previously untreated or metastatic ureter urothelial carcinoma."

Answered by AI

Are we still looking for people to enroll in this research project?

"Unfortunately, this study is not presently looking for participants, however, it was first posted on 11/17/2020. Although this study isn't currently active, there are many other trials (487 to be precise) that are seeking patients right now."

Answered by AI
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~192 spots leftby Feb 2025