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Monoclonal Antibodies

Chemotherapy + Immunotherapy for Esophageal Cancer

Phase 2
Recruiting
Led By Mariela Blum
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (1500/uL) without granulocyte colony-stimulating factor support (obtained within 14 days prior to initiation of study treatment)
Patients with T1N1, and T2-3 with any N will be eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is testing a combination of atezolizumab, oxaliplatin, and fluorouracil to treat patients with esophageal or gastroesophageal cancer.

Who is the study for?
This trial is for adults with localized esophageal or gastroesophageal adenocarcinoma who haven't had prior treatments. They must have certain blood and organ function levels, not be pregnant or breastfeeding, use contraception, and be medically fit for surgery. People with specific other health conditions or cancers are excluded.Check my eligibility
What is being tested?
The study tests if atezolizumab combined with chemotherapy (oxaliplatin and fluorouracil) before surgery can control cancer better than current methods. It also examines the addition of tiragolumab to this combination to see if it offers further benefits.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system affecting organs, infusion-related reactions from the drugs being administered, fatigue, digestive issues like nausea or diarrhea, changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My white blood cell count is healthy without needing medication.
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My cancer is in an early stage but has spread to nearby lymph nodes.
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My platelet count is at least 100,000 without needing a transfusion.
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I am not pregnant, have tested negative for pregnancy, and am not breastfeeding.
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My cancer is a type of esophageal or gastroesophageal adenocarcinoma.
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I have not had any chemotherapy or radiation therapy before.
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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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
Pathological complete response (PathCR)
Secondary outcome measures
Changes in tumor stroma profile after treatment
Disease-free survival (DFS)
Incidence of toxicities defined as any treatment-related grade 3 or greater non-hematologic adverse events (AEs) determined by CTCAE version v 4.03.
+2 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Dyspnoea
19%
Cough
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Chest pain
4%
Productive cough
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Aspartate aminotransferase increased
2%
Alanine aminotransferase increased
2%
Influenza like illness
1%
Acute kidney injury
1%
Lower respiratory tract infection
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2- Atezolizumab plus and Tiragolumab with Oxaliplatin and 5-fluorouracil (5-FU)Experimental Treatment5 Interventions
The combination of Atezolizumab + Tiragolumab with Oxaliplatin and 5-Flourouracil IV on Days 1 and 15 of each 28-day cycle for total of 6 doses followed by surgery followed by Atezolizumab + Tiragolumab on Day 1 of each 21-day cycle for a total of 48 weeks.
Group II: Cohort 1-Atezolizumab combination with Oxaliplatin and 5-fluorouracil (5-FU)Experimental Treatment4 Interventions
The combination of Atezolizumab with Oxaliplatin and 5-Fluorouracil IV on Days 1 and 15 of each 28-day cycle for total of 6 doses followed by surgery followed by Atezolizumab on Day 1 of each 21-day cycle for total of 24 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluorouracil
2014
Completed Phase 3
~11540
Tiragolumab
2020
Completed Phase 2
~460
Atezolizumab
2017
Completed Phase 3
~5860
Conventional Surgery
2006
Completed Phase 3
~1080
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,239 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,743 Previous Clinical Trials
40,957,807 Total Patients Enrolled
Mariela BlumPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
47 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03784326 — Phase 2
Gastroesophageal Junction Adenocarcinoma Research Study Groups: Cohort 2- Atezolizumab plus and Tiragolumab with Oxaliplatin and 5-fluorouracil (5-FU), Cohort 1-Atezolizumab combination with Oxaliplatin and 5-fluorouracil (5-FU)
Gastroesophageal Junction Adenocarcinoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03784326 — Phase 2
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03784326 — Phase 2
~3 spots leftby Dec 2024