What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for gastrointestinal tumors, particularly those involving PD-1/PD-L1 inhibitors like Durvalumab, often result in side effects such as fatigue, nausea, diarrhea, and immune-related adverse events. For instance, pembrolizumab, another PD-1 inhibitor, has been associated with fatigue (20.8%), pruritus (16.7%), and pyrexia (12.5%). Additionally, immune-mediated colitis and pneumonitis are notable concerns, with severe cases being relatively rare but requiring careful management. These side effects are consistent across various immunotherapies used in treating gastrointestinal and other cancers.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of gastrointestinal tumors. Pembrolizumab (Keytruda), a PD-1 inhibitor, has been approved for use in advanced gastric or gastroesophageal junction cancer, as demonstrated in the KEYNOTE-590 study. Nivolumab (Opdivo), another PD-1 inhibitor, has also been approved for HER2-negative, untreated, unresectable advanced or recurrent gastric or gastroesophageal junction cancer, as shown in the ATTRACTION-4 trial. These treatments are similar to Durvalumab, which is a PD-L1 inhibitor currently being studied in combination with FLOT chemotherapy for resectable gastric and gastroesophageal junction cancer.

What other types of research exist?

Promising alternatives to Durvalumab for gastrointestinal tumors include Pembrolizumab (PD-1 inhibitor), Nivolumab (PD-1 inhibitor), and Camrelizumab (PD-1 inhibitor). These agents have shown efficacy in clinical trials for various gastrointestinal cancers and are viable options for treatment in 2024.

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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

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.

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.

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.

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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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer is either adenosquamous, squamous cell, or a GI stromal tumor.

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I have received an organ transplant from another person.

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My cancer has spread to the lining of my abdomen or other distant parts.

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I am not allergic or intolerant to the drugs used in this study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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

Vomiting

Dyspnoea

Back pain

Oedema peripheral

Pyrexia

Arthralgia

Hypothyroidism

Haematuria

Abdominal pain

Blood creatinine increased

Weight decreased

Sepsis

Tumour hyperprogression

General physical health deterioration

Pneumonia

Death

Acute kidney injury

Pyelonephritis

Device related infection

Urosepsis

Pulmonary embolism

100%

80%

60%

40%

20%

Study treatment Arm

Durvalumab

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 2

~3750

0 / 8Eligibility criteria met

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.