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Taxane

Immunotherapy + Chemoradiotherapy for Gastroesophageal Cancer

Houston, TX
Phase 1
Waitlist Available
Led By Jaffer A Ajani
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 20 Other Conditions

Summary

This trial tests immunotherapy with chemo/radiotherapy to treat unresectable gastroesophageal cancer.

See full description
Who is the study for?
This trial is for adults with advanced gastroesophageal cancer that can't be removed by surgery. They should have a good performance status, meaning they're fairly active and able to care for themselves. Participants must not be pregnant or breastfeeding, agree to use contraception, and have adequate organ function as shown by specific blood tests.
What is being tested?
The study is testing the combination of pembrolizumab (an immune system-boosting drug) with chemoradiotherapy (a mix of chemotherapy drugs and radiation therapy). The goal is to see if this combo is better at controlling gastroesophageal cancer compared to standard treatments.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system such as inflammation in different parts of the body, infusion-related reactions from the drug entering your bloodstream, fatigue, nausea, low blood counts increasing infection risk, and potential damage to organs from high-energy radiation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical complete response (cCR)
Secondary study objectives
Median progression free survival (PFS)
Number of participants discontinuing study drug due to AEs
Number of participants experiencing adverse events (AEs)
+4 more

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999
64%
Radiation skin injury
63%
Stomatitis
58%
Anaemia
56%
Nausea
48%
Dry mouth
45%
Constipation
45%
Weight decreased
44%
Dysphagia
42%
Neutrophil count decreased
33%
Dysgeusia
33%
Vomiting
32%
Fatigue
31%
White blood cell count decreased
28%
Hypomagnesaemia
26%
Decreased appetite
25%
Hypothyroidism
25%
Hypokalaemia
24%
Lymphocyte count decreased
24%
Platelet count decreased
23%
Oropharyngeal pain
23%
Blood creatinine increased
22%
Diarrhoea
22%
Odynophagia
20%
Hypoacusis
20%
Alanine aminotransferase increased
20%
Hyponatraemia
19%
Tinnitus
19%
Oral candidiasis
19%
Asthenia
16%
Pyrexia
16%
Cough
15%
Aspartate aminotransferase increased
15%
Rash
14%
Insomnia
13%
Acute kidney injury
13%
Pharyngeal inflammation
13%
Pruritus
12%
Dysphonia
12%
Gamma-glutamyltransferase increased
11%
Pneumonia
11%
Dehydration
10%
Hyperthyroidism
10%
Hypoalbuminaemia
10%
Hypocalcaemia
10%
Headache
10%
Productive cough
9%
Neck pain
9%
Peripheral sensory neuropathy
8%
Gastrooesophageal reflux disease
8%
Hiccups
8%
Hyperglycaemia
8%
Hyperuricaemia
8%
Dizziness
8%
Hypophosphataemia
7%
Localised oedema
7%
Urinary tract infection
7%
Ear pain
7%
Hyperkalaemia
7%
Erythema
7%
Oral pain
6%
Abdominal pain upper
6%
Arthralgia
6%
Anxiety
6%
Febrile neutropenia
6%
Dyspepsia
6%
Saliva altered
5%
Back pain
5%
Oedema peripheral
5%
Hypertension
5%
Dyspnoea
4%
Nasopharyngitis
4%
Alopecia
4%
Dry skin
3%
Pneumonia aspiration
3%
Sepsis
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Cardiac arrest
1%
Systemic infection
1%
Septic shock
1%
Clostridium difficile colitis
1%
Death
1%
Bronchitis
1%
Hepatitis
1%
Immune-mediated hepatitis
1%
Oesophagitis
1%
General physical health deterioration
1%
Hypophagia
1%
Tumour haemorrhage
1%
Cerebrovascular accident
1%
Syncope
1%
Acute respiratory failure
1%
Aspiration
1%
Colitis
1%
Mouth haemorrhage
1%
Hypersensitivity
1%
Acute myocardial infarction
1%
Abscess neck
1%
Device related infection
1%
Stoma site infection
1%
Vascular device infection
1%
Wound infection
1%
Hypercalcaemia
1%
Pulmonary embolism
1%
Respiratory failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo + CRT Followed by Placebo
Pembrolizumab + CRT Followed by Pembrolizumab

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab, chemoradiotherapy)Experimental Treatment5 Interventions
See Detailed Description
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
FDA approved
Fluorouracil
FDA approved
Oxaliplatin
FDA approved
Pembrolizumab
FDA approved
Radiation Therapy
2004
Completed Phase 3
~7740

Find a Location

Closest Location:M D Anderson Cancer Center· Houston, TX· 998 miles

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,099 Previous Clinical Trials
1,812,539 Total Patients Enrolled
National Cancer Institute (NCI)NIH
14,057 Previous Clinical Trials
41,149,407 Total Patients Enrolled
Jaffer A AjaniPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

Docetaxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT04522336 — Phase 1
Gastroesophageal Junction Cancer Research Study Groups: Treatment (pembrolizumab, chemoradiotherapy)
Gastroesophageal Junction Cancer Clinical Trial 2023: Docetaxel Highlights & Side Effects. Trial Name: NCT04522336 — Phase 1
Docetaxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04522336 — Phase 1
~1 spots leftby Jul 2025