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Taxane
Immunotherapy + Chemoradiotherapy for Gastroesophageal Cancer
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 10 Other Conditions
Summary
This trial tests immunotherapy with chemo/radiotherapy to treat unresectable gastroesophageal cancer.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
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 moreSide effects data
From 2024 Phase 3 trial • 804 Patients • NCT0304099964%
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%
Urinary tract infection
7%
Ear pain
7%
Localised oedema
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%
Sepsis
3%
Pneumonia aspiration
3%
Trismus
3%
Pneumonitis
3%
Laryngeal oedema
2%
Malnutrition
2%
Pharyngeal haemorrhage
2%
Cellulitis
1%
Septic shock
1%
Clostridium difficile colitis
1%
Systemic infection
1%
Cardiac arrest
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 10 Other Conditions
This treatment demonstrated efficacy for 10 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
2017
Completed Phase 3
~7250
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,802,229 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,925 Previous Clinical Trials
41,017,985 Total Patients Enrolled
Jaffer A AjaniPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an autoimmune disease treated with medication in the last 2 years.I have been treated with specific immune therapy drugs before.I am on replacement therapy like thyroxine or insulin, not systemic treatment.My brain cancer has not worsened recently.I have not had serious heart problems in the last 6 months.My cancer in the stomach or esophagus cannot be removed by surgery.I have fluid buildup in my abdomen or chest but am stable after treatment.I have mild to severe nerve damage in my hands or feet.I am highly allergic to pembrolizumab or its ingredients.My blood clotting tests are normal or within the treatment range if I'm on blood thinners.I have not received any colony-stimulating factors in the last 2 weeks.I have recovered from any major surgery before starting the study.My kidney function tests are within the required range.I agree to use contraception and not donate sperm for 120 days after my last treatment dose.My cancer is advanced and cannot be removed by surgery, or I chose not to have surgery.My brain metastases are stable, and I haven't needed steroids for 14 days.I have had pneumonitis treated with steroids or have it now.I have had treatment for cancer that includes trial medicines.I am currently being treated for an infection.I am fully active or restricted in physically strenuous activity but can do light work.I am not pregnant, not breastfeeding, and meet one of the specified conditions.I may need a blood transfusion due to my tumor causing blood loss.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I have a history of hepatitis B or active hepatitis C.I have had radiation therapy for my current illness.I have not received a live vaccine in the last 30 days.My cancer is only in my stomach and not near the area where my stomach meets my esophagus.I haven't had major surgery or significant injury in the last 28 days and don't expect to need major surgery during the study.I have cancer that has spread to my brain or spinal cord.I have received an organ or tissue transplant from another person.I have another cancer that is getting worse or was treated in the last 2 years.I can undergo endoscopic biopsies and give blood for research.I had skin or early cervical cancer but was treated with the intent to cure.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab, chemoradiotherapy)
Awards:
This trial has 3 awards, including:- 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 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
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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