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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
Must not have
Patients with T1aN0, T4b, or M1 cancer will be excluded
Patients with a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
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 belowSelect...
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.
Select...
My cancer is a type of esophageal or gastroesophageal adenocarcinoma.
Select...
I have not had any chemotherapy or radiation therapy before.
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I am fully active or can carry out light work.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My cancer is not classified as T1aN0, T4b, or M1.
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I tested negative for HBsAg and positive for HBcAb.
Select...
I do not have uncontrolled diabetes, heart issues, high blood pressure, or mental health conditions that would prevent my participation.
Select...
I have active tuberculosis.
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My primary tumor is actively bleeding and needs radiation.
Select...
My calcium levels are not higher than normal and I don't have symptoms of high calcium.
Select...
I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.
Select...
I have an active hepatitis B infection.
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I am allergic to oxaliplatin or 5-FU medications.
Select...
I have a history of certain lung conditions or signs of lung inflammation on a recent CT scan.
Select...
I have an active hepatitis C infection confirmed by tests.
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I have previously been treated with specific immune therapies.
Select...
My cancer has spread to nearby organs and there's a risk of developing a fistula.
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I have had a stem cell or organ transplant in the past.
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My cancer is identified as squamous cell carcinoma.
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I have not had a severe infection or been hospitalized for one in the last 4 weeks.
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I experience significant numbness or pain in my hands or feet.
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I do not have serious heart problems like recent heart attacks or unstable heart conditions.
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I have not received a live vaccine in the last 4 weeks and do not plan to during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
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 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Weight decreased
5%
Haemoptysis
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Lung infection
1%
Acute kidney injury
1%
Lower respiratory tract infection
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Depression
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 3
~1000
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
13,748 Previous Clinical Trials
40,959,361 Total Patients Enrolled
Mariela BlumPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
47 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is not classified as T1aN0, T4b, or M1.I tested negative for HBsAg and positive for HBcAb.My white blood cell count is healthy without needing medication.I do not have uncontrolled diabetes, heart issues, high blood pressure, or mental health conditions that would prevent my participation.I have active tuberculosis.My primary tumor is actively bleeding and needs radiation.My calcium levels are not higher than normal and I don't have symptoms of high calcium.My hemoglobin level is at least 9 g/dL, possibly after a transfusion.I haven't had major surgery in the last 4 weeks and don't expect to need one during the study.I have an active hepatitis B infection.My cancer is in an early stage but has spread to nearby lymph nodes.I am allergic to oxaliplatin or 5-FU medications.My blood thinner medication dose has been stable.I haven't taken antibiotics for treatment in the last 2 weeks, but I may be on preventive antibiotics.I have a history of certain lung conditions or signs of lung inflammation on a recent CT scan.My skin condition is mild, covers less than 10% of my body, and hasn't needed strong treatments in the last year.I am using effective birth control while on treatment.I haven't taken strong immune system medications in the last 2 weeks.I have an autoimmune disease but it's either hypothyroidism treated with hormones or controlled type 1 diabetes.I am healthy enough to undergo surgery.My blood clotting tests are within normal limits and I'm not on blood thinners.I have an active hepatitis C infection confirmed by tests.I have previously been treated with specific immune therapies.My platelet count is at least 100,000 without needing a transfusion.My cancer has spread to nearby organs and there's a risk of developing a fistula.I do not have any health conditions that would make it unsafe for me to take a new drug.I haven't had any cancer, except some low-risk types, in the last 5 years.I am not pregnant, have tested negative for pregnancy, and am not breastfeeding.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.My kidney function, measured by creatinine levels, is within the required range.I have had a stem cell or organ transplant in the past.My cancer is identified as squamous cell carcinoma.I understand and can follow the study's requirements.I have not had a severe infection or been hospitalized for one in the last 4 weeks.I can provide a tumor sample for PDL-1 testing.I experience significant numbness or pain in my hands or feet.My cancer is a type of esophageal or gastroesophageal adenocarcinoma.I have not had any chemotherapy or radiation therapy before.I am fully active or can carry out light work.I do not have serious heart problems like recent heart attacks or unstable heart conditions.I have not received a live vaccine in the last 4 weeks and do not plan to during the study.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 2- Atezolizumab plus and Tiragolumab with Oxaliplatin and 5-fluorouracil (5-FU)
- Group 2: Cohort 1-Atezolizumab combination with Oxaliplatin and 5-fluorouracil (5-FU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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