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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
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
Tiragolumab
2020
Completed Phase 2
~350
Atezolizumab
2016
Completed Phase 3
~6040
Conventional Surgery
2006
Completed Phase 3
~1080
Fluorouracil
2014
Completed Phase 3
~11540
Oxaliplatin
2011
Completed Phase 4
~2560

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,962 Previous Clinical Trials
1,803,325 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,307 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

Frequently Asked Questions

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

How many people are included in this clinical trial?

"That is correct, the clinical trial listed on clinicaltrials.gov is open and presently looking for 30 individuals to participate at 1 location."

Answered by AI

Are there still open spots for people who want to participate in this research?

"Yes, this is an active study that has updated their recruitment information as recently as October 5th, 2022. 30 individuals are needed to participate at a single location."

Answered by AI

Atezolizumab is most commonly used to treat what condition?

"Atezolizumab is primarily used to fight small cell lung cancer, but can also assist patients with malignant neoplasms, superficial basal cell carcinoma, and rectal carcinoma."

Answered by AI

Could you tell me if Atezolizumab has been studied before?

"Atezolizumab is being studied in 860 active clinical trials, with 246 of those in Phase 3. While there is a large concentration of these studies in Guangzhou, Guangdong, there are 39466 total locations for these trials."

Answered by AI

Has Atezolizumab been linked with any adverse health effects?

"Atezolizumab is a medication that, while having some clinical data supporting its safety, has not yet been proven effective. Our team believes it deserves a score of 2."

Answered by AI
~5 spots leftby Dec 2024