Atezolizumab for Esophageal Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Esophageal Adenocarcinoma+23 MoreAtezolizumab - Drug
Eligibility
18+
All Sexes
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Study Summary

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

Eligible Conditions
  • Esophageal Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IB Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIA Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIA Esophageal Adenocarcinoma
  • Pathologic Stage II Esophageal Adenocarcinoma
  • Pathologic Stage IIB Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IC Gastroesophageal Junction Adenocarcinoma
  • Clinical Stage IIA Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage II Gastroesophageal Junction Adenocarcinoma
  • Esophageal Adenocarcinoma Stage IIB
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma

Treatment Effectiveness

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Up to 3 years

Year 3
Changes in tumor stroma profile after treatment
Tumor regression determined by CT or MRI
Month 3
Incidence of toxicities defined as any treatment-related grade 3 or greater non-hematologic adverse events (AEs) determined by CTCAE version v 4.03.
Up to 3 years
Disease-free survival (DFS)
Overall survival (OS)
Pathological complete response (PathCR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Atezolizumab
27%Fatigue
25%Decreased appetite
24%Cough
19%Asthenia
19%Dyspnoea
18%Constipation
18%Nausea
18%Pyrexia
16%Diarrhoea
13%Arthralgia
12%Vomiting
12%Anaemia
11%Rash
11%Back pain
11%Musculoskeletal pain
10%Headache
9%Oedema peripheral
9%Weight decreased
9%Insomnia
9%Chest pain
9%Pruritus
9%Pain in extremity
8%Dizziness
7%Aspartate aminotransferase increased
7%Haemoptysis
7%Upper respiratory tract infection
7%Myalgia
6%Influenza like illness
6%Alanine aminotransferase increased
6%Bronchitis
6%Nasopharyngitis
6%Productive cough
5%Dry skin
5%Depression
5%Musculoskeletal chest pain
4%Urinary tract infection
4%Paraesthesia
4%Neuropathy peripheral
4%Abdominal pain
3%Stomatitis
3%Pneumonia
3%Dysgeusia
2%Pleural effusion
2%Malaise
2%Neutropenia
1%Respiratory tract infection
1%Pulmonary embolism
1%Peripheral sensory neuropathy
1%Sepsis
1%Pneumonitis
1%Alopecia
1%Mucosal inflammation
1%Bone pain
1%Lacrimation increased
This histogram enumerates side effects from a completed 2019 Phase 3 trial (NCT02008227) in the Atezolizumab ARM group. Side effects include: Fatigue with 27%, Decreased appetite with 25%, Cough with 24%, Asthenia with 19%, Dyspnoea with 19%.

Trial Design

1 Treatment Group

Treatment (oxaliplatin, fluorouracil, atezolizumab, surgery)
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Atezolizumab · No Placebo Group · Phase 2

Treatment (oxaliplatin, fluorouracil, atezolizumab, surgery)Experimental Group · 4 Interventions: Atezolizumab, Fluorouracil, Oxaliplatin, Conventional Surgery · Intervention Types: Drug, Drug, Drug, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Conventional Surgery
2006
Completed Phase 3
~1000

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,802 Previous Clinical Trials
1,788,869 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,071 Previous Clinical Trials
41,128,825 Total Patients Enrolled
Mariela BlumPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
45 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

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