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Chemotherapy
Oxaliplatin+Capecitabine+Pembrolizumab for Stomach Cancer
Phase 2
Waitlist Available
Led By Hope Uronis, MD
Research Sponsored by Duke University
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 44 months
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a combination of three drugs to treat advanced stomach and esophagus cancer. It aims to see if the combination can help patients live longer without their cancer getting worse. The study will first check if the treatment is safe, then see how well it works. The combination of treatments has improved outcomes for patients with esophageal cancer.
Eligible Conditions
- Stomach Cancer
- Esophageal Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 44 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 44 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Months of Progression-free Survival (PFS)
Secondary study objectives
Months of Overall Survival
Response Rate as Measured by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Side effects data
From 2023 Phase 2 trial • 36 Patients • NCT0334293742%
Anorexia
42%
Nausea
39%
Fatigue
39%
Anemia
36%
Peripheral sensory neuropathy
36%
Diarrhea
31%
Neutrophil count decreased
31%
Hypoalbuminemia
31%
Palmar-plantar erythrodysesthesia syndrome
28%
Vomiting
25%
White blood cell decreased
25%
Weight loss
19%
Dehydration
19%
Hyperglycemia
17%
Hypokalemia
17%
Hypertension
14%
Insomnia
14%
Thromboembolic event
14%
Cough
14%
Blood bilirubin increased
14%
Colitis
14%
Dysphagia
14%
Allergic rhinitis
11%
Hyponatremia
11%
Rash maculo-papular
11%
Constipation
11%
Urinary tract infection
11%
Bloating
11%
Dyspepsia
11%
Mucositis oral
11%
Alkaline phosphatase increased
11%
Anxiety
8%
Hypothyroidism
8%
Dysgeusia
8%
Dyspnea
8%
Hiccups
8%
Abdominal pain
8%
Abdominal distension
8%
Aspartate aminotransferase increased
8%
Platelet count decreased
8%
Myalgia
6%
Colonic obstruction
6%
Adrenal insufficiency
6%
Arthralgia
6%
Dysesthesia
6%
Pleural effusion
6%
Skin ulceration
6%
Hypotension
6%
Skin infection
6%
Dry skin
6%
Otitis media
6%
Malaise
6%
Lung infection
6%
Flatulence
6%
Pain
6%
Esophagitis
6%
Gastroesophageal reflux disease
6%
Alanine aminotransferase increased
6%
Weight gain
3%
Eye infection
3%
Pericardial tamponade
3%
Sinus tachycardia
3%
Enterocolitis infectious
3%
Infections and infestations - Other, Specify
3%
Vertigo
3%
Toothache
3%
Fever
3%
Gait disturbance
3%
Localized edema
3%
Non-cardiac chest pain
3%
Hypocalcemia
3%
Hypoglycemia
3%
Metabolism and nutrition disorders - Other, Specify
3%
Arthritis
3%
Musculoskeletal and connective tissue disorder - Other, Specify
3%
Paresthesia
3%
Presyncope
3%
Syncope
3%
Urinary incontinence
3%
Nasal congestion
3%
Pneumonitis
3%
Sore throat
3%
Voice alteration
3%
Wheezing
3%
Skin and subcutaneous tissue disorders - Other, Specify
3%
Skin hypopigmentation
3%
Superficial thrombophlebitis
3%
Endocrine disorders - Other, Specify
3%
Sinusitis
3%
Nail loss
3%
Fecal incontinence
3%
Generalized muscle weakness
3%
Cystitis noninfective
3%
Pruritus
3%
Sudden death NOS
3%
Venous injury
3%
Postnasal drip
3%
Dizziness
3%
Dry mouth
3%
Otitis externa
3%
INR increased
3%
Allergic reaction
3%
Bruising
3%
Hoarseness
3%
Esophageal pain
3%
Upper respiratory infection
3%
Edema limbs
3%
Ascites
3%
Wound infection
3%
Urinary retention
3%
Flank pain
3%
Hepatobiliary disorders - Other, Specify
3%
Esophageal infection
3%
Lymphocyte count decreased
3%
Tumor pain
3%
Joint range of motion decreased
3%
Meningitis
3%
Sepsis
3%
Urinary frequency
3%
Device related infection
3%
Bone pain
3%
Hyperthyroidism
3%
Gastrointestinal disorders - Other, Specify
3%
Creatinine increased
3%
Hyperkalemia
3%
Hypophosphatemia
3%
Muscle weakness lower limb
3%
Muscle weakness upper limb
3%
Erectile dysfunction
3%
Pelvic pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Oxaliplatin + Capecitabine + Pembrolizumab
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Oxaliplatin+Capecitabine+PembrolizumabExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Oxaliplatin+Capecitabine+Pembrolizumab
2018
Completed Phase 2
~40
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,001 Previous Clinical Trials
5,184,875 Total Patients Enrolled
Duke UniversityLead Sponsor
2,451 Previous Clinical Trials
3,067,034 Total Patients Enrolled
Hope Uronis, MDPrincipal InvestigatorDuke University
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