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PD-1 Inhibitor

Pembrolizumab Injection for Esophageal Cancer

Phase 2

Waitlist Available

Led By Daniel Catenacci, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 11 weeks

Awards & highlights

Study Summary

This trial looks at the effect of the drug pembrolizumab on patients with a certain type of cancer.

Eligible Conditions

Esophageal Cancer
Gastroesophageal Junction Adenocarcinoma
Stomach Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 11 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~11 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 11 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Pathologic complete response (pCR) rate

Secondary outcome measures

Basic reproduction number (R0) resection rate

Disease Free Survival rate (DFS)

Number of patients with GEA taking pembrolizumab with treatment-related adverse events

+2 more

Side effects data

From 2022 Phase 2 trial • 80 Patients • NCT04099641

34%

Decreased appetite

33%

Fatigue

30%

Nausea

26%

Constipation

26%

Diarrhoea

25%

Vomiting

23%

Anaemia

21%

Abdominal pain

18%

Dyspnoea

16%

Oedema peripheral

16%

Weight decreased

15%

Pyrexia

15%

Dizziness

13%

Alanine aminotransferase increased

13%

Aspartate aminotransferase increased

13%

Abdominal pain upper

13%

Chills

11%

Gastric cancer

11%

Hypothyroidism

11%

Headache

11%

Hypertension

11%

Myalgia

11%

Arthralgia

10%

Asthenia

10%

Hypoalbuminaemia

10%

Abdominal distention

10%

Back pain

Depression

Insomnia

Ascites

Dysphagia

Urinary tract infection

Muscular weakness

Rash

Dyspepsia

Fall

Hyponatraemia

Pleural effusion

Blood alkaline phosphatase increased

Blood creatinine increased

Dysuria

Hyperkalaemia

Hypotension

Dry skin

Infusion related reaction

Abdominal discomfort

Upper gastrointestinal haemorrhage

Dehydration

Death

Hypokalaemia

Generalized oedema

Cough

Vision blurred

Peripheral sensory neuropathy

Blood bilirubin increased

Hypophosphataemia

Multiple organ dysfunction syndrome

Atrioventricular block

Biliary tract infection

Cancer pain

Metastatic gastric cancer

Disease progression

Acute myocardial infarction

Corona virus infection

Oesophageal cancer metastatic

Encephalopathy

Acute respiratory failure

Facial paralysis

Loss of consciousness

Transient ischaemic attack

Acute kidney injury

Malignant urinary tract obstruction

Gastrointestinal haemorrhage

Pneumonia aspiration

Pneumonitis

Hypoxia

Respiratory failure

Upper respiratory tract infection

Pelvic pain

Neutrophil count decreased

Blood cholesterol increased

Large intestinal obstruction

Obstruction gastric

Cardiac arrest

Malignant ascites

Urinary tract obstruction

Benign prostatic hyperplasia

100%

80%

60%

40%

20%

Study treatment Arm

Group 1 (CPI Naïve)

Group 2 (CPI Relapse)

Trial Design

1Treatment groups

Experimental Treatment

Group I: ARM 1Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor

1,003 Previous Clinical Trials

819,746 Total Patients Enrolled

Daniel Catenacci, MDPrincipal InvestigatorUniversity of Chicago

4 Previous Clinical Trials

1,180 Total Patients Enrolled

Frequently Asked Questions

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

What health conditions are conventionally treated with Pembrolizumab Injection?

"Pembrolizumab Injection is typically used to treat cancerous tumours. However, it can also be employed in the management of advanced melanoma, microsatellite instability high and chemotherapy-resistant progression states."

Answered by AI

How have Pembrolizumab Injection been utilized in prior medical experiments?

"Currently, there are 961 ongoing clinical trials related to Pembrolizumab Injection with 122 of those in Phase 3. Over 35 thousand sites across the nation offer studies on this medication, although many are located near Houston, Texas."

Answered by AI

Are any individuals currently being sought to partake in this research study?

"Yes, the data provided on clinicaltrials.gov verifies that this medical trial has been actively seeking participants since its initial posting in November of 2019 and was most recently updated June 7th 2021. The study is looking to recruit 33 individuals from a single clinic location."

Answered by AI

What is the participant threshold for this trial?

"That is correct. According to information hosted on clinicaltrials.gov, this medical trial launched on October 11th 2019 and was most recently updated June 7th 2021. 33 volunteers are needed from a single site for the study's duration."

Answered by AI

Has the Food and Drug Administration (FDA) authorized Pembrolizumab Injection?

"The safety of Pembrolizumab Injection was judged to be a 2 due to the fact that there is some data suggesting its security, although no evidence indicating it's efficacy in this particular Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma

2019. "Phase II Trial of Neoadjuvant Pembrolizumab for Patients With Early Stage Gastroesophageal Adenocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04089904.