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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 weeks
Treatment ~ Varies
Follow Up ~up to 44 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 44 months for reporting.

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 • NCT03342937
42%
Nausea
42%
Anorexia
39%
Fatigue
39%
Anemia
36%
Peripheral sensory neuropathy
36%
Diarrhea
31%
Hypoalbuminemia
31%
Neutrophil count decreased
31%
Palmar-plantar erythrodysesthesia syndrome
28%
Vomiting
25%
White blood cell decreased
25%
Weight loss
19%
Dehydration
19%
Hyperglycemia
17%
Hypokalemia
17%
Hypertension
14%
Cough
14%
Thromboembolic event
14%
Insomnia
14%
Blood bilirubin increased
14%
Colitis
14%
Dysphagia
14%
Allergic rhinitis
11%
Hyponatremia
11%
Constipation
11%
Rash maculo-papular
11%
Urinary tract infection
11%
Bloating
11%
Dyspepsia
11%
Mucositis oral
11%
Alkaline phosphatase increased
11%
Anxiety
8%
Dysgeusia
8%
Dyspnea
8%
Hypothyroidism
8%
Hiccups
8%
Abdominal pain
8%
Abdominal distension
8%
Aspartate aminotransferase increased
8%
Platelet count decreased
8%
Myalgia
6%
Adrenal insufficiency
6%
Pleural effusion
6%
Dysesthesia
6%
Skin infection
6%
Dry skin
6%
Otitis media
6%
Colonic obstruction
6%
Malaise
6%
Lung infection
6%
Flatulence
6%
Pain
6%
Skin ulceration
6%
Hypotension
6%
Arthralgia
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%
Toothache
3%
Fever
3%
Gait disturbance
3%
Localized edema
3%
Non-cardiac chest pain
3%
Hypoglycemia
3%
Urinary incontinence
3%
Voice alteration
3%
Metabolism and nutrition disorders - Other, Specify
3%
Flank pain
3%
Musculoskeletal and connective tissue disorder - Other, Specify
3%
Pneumonitis
3%
Wheezing
3%
Skin and subcutaneous tissue disorders - Other, Specify
3%
Skin hypopigmentation
3%
Sinusitis
3%
Nail loss
3%
Sore throat
3%
Generalized muscle weakness
3%
Cystitis noninfective
3%
Pruritus
3%
Sudden death NOS
3%
Superficial thrombophlebitis
3%
Fecal incontinence
3%
Venous injury
3%
Postnasal drip
3%
Vertigo
3%
Dizziness
3%
Dry mouth
3%
Otitis externa
3%
INR increased
3%
Bruising
3%
Hoarseness
3%
Allergic reaction
3%
Esophageal pain
3%
Upper respiratory infection
3%
Arthritis
3%
Nasal congestion
3%
Endocrine disorders - Other, Specify
3%
Presyncope
3%
Edema limbs
3%
Hypocalcemia
3%
Ascites
3%
Wound infection
3%
Urinary retention
3%
Hepatobiliary disorders - Other, Specify
3%
Paresthesia
3%
Esophageal infection
3%
Infections and infestations - Other, Specify
3%
Syncope
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
4,010 Previous Clinical Trials
5,185,207 Total Patients Enrolled
Duke UniversityLead Sponsor
2,454 Previous Clinical Trials
2,971,575 Total Patients Enrolled
Hope Uronis, MDPrincipal InvestigatorDuke University
~5 spots leftby Nov 2025
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