Study Summary
This trial is testing if radiation therapy can help treat gastrointestinal cancer that has spread to other parts of the body, in combination with immunotherapy.
Eligible Conditions
- Esophageal Squamous Cell Carcinoma
- Esophageal Squamous Cell Carcinoma (Stage IV)
- Esophageal Squamous Cell Carcinoma (Stage IVA)
- Esophageal Squamous Cell Carcinoma, Stage IVB
- Stage IVB Gastroesophageal Junction Adenocarcinoma
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Stomach Cancer
- Metastatic Small Intestinal Cancer
- Esophageal Adenocarcinoma
- Esophageal Adenocarcinoma Postneoadjuvant Therapy Stage IVA AJCC v8
- Stage IVB Gastric Cancer
- Advanced Adenocarcinoma of the Gastroesophageal Junction
- Stage IV Liver Cancer
- Stage IV Anal Cancer
- Esophageal Cancer
- Esophageal Squamous Cell Carcinoma Stage IVA
- Esophageal Adenocarcinoma (Stage IVB)
- Pancreatic Biliary Cancer
- Metastatic Malignant Digestive System Cancer
- Esophageal Squamous Cell Carcinoma (Stage IVB)
- Esophageal Adenocarcinoma (Stage IVA)
- Anal Cancer
- Liver Cancer
- Esophageal Cancer (Stage IV)
- Gastric Cancer
- Esophageal Squamous Cell Carcinoma Post-Neoadjuvant Therapy Stage IV
- Stage IV Gastric Cancer
- Stage IVA Hepatocellular Carcinoma
- Stage IVA Gastric Cancer
- Stage IVA Colorectal Cancer
- Postneoadjuvant Therapy Stage IV Gastric Cancer
- Stage IVB Hepatocellular Carcinoma
- Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma
- Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma
- Stage IVB Colorectal Cancer
- Stage IV Colorectal Cancer
- Colorectal Cancer
- Stage IVC Colorectal Cancer
- Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma
- Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Up to 36 months
Up to 36 months
Determine local control in radiated lesion(s)
Frequency of grade 3 or higher adverse events
Overall survival (OS)
Progression free survival (PFS)
Time to new systemic therapy
Up to 8 weeks
Incidence of New metastatic lesions
ORR by immune-Modified Response Evaluation Criteria in Solid Tumors (iRECIST)
Overall response rate (ORR)
Tumor measurement change by RECIST or iRECIST
Trial Safety
Phase-Based Safety
Side Effects for
Nivolumab + Ipilimumab + Short-course Radiation Therapy
70%Lymphocyte Count Decreased
60%Alanine Aminotransferase Increased
50%Anemia
50%Rash Maculopapular
40%Hyponatremia
40%Platelet Count Decreased
40%Aspartate Aminotransferase Increased
30%Fatigue
30%Confusion
30%Diarrhea
30%Serum Amylase Increased
20%Dizziness
20%Insomnia
20%Nausea
20%Creatinine Increased
20%Paresthesia
20%Seizure
20%Chest Wall Pain
20%Generalized Muscle Weakness
20%Hyperglycemia
20%Lipase increased
20%Headache
20%Hypophosphatemia
20%Pyramidal Tract Syndrome
10%Dysphagia
10%Fall
10%Gastroesophageal reflux disease
10%Hoarseness
10%Peripheral Motor Neuropathy
10%Somnolence
10%Agitation
10%Hypoglycemia
10%Eye disorder, other; Diplopia
10%Papulopustular Rash
10%Nasal Congestion
10%Hyperkalemia
10%Oculomotor nerve disorder
10%Dry Mouth
10%Hypotension
10%Alopecia
10%Arthralgia
10%Conjunctivitis
10%Epistaxis
10%Flatulence
10%Abdominal Pain
10%Depression
10%Dry eye
10%Dysarthria
10%Bruising (Injection Site)
10%Dysgeusia
10%Delirium
10%Hypoalbuminemia
10%Pain
10%Restlessness
10%Sinus Bradycardia
10%Encephalopathy
10%Alkaline phosphatase increased
10%Localized Edema
10%Tremor
10%Central Nervous System Necrosis
10%Facial nerve disorder
10%Anxiety
10%Lymphocyte count increased
10%Blood lactate dehydrogenase increased
10%Hypomagnesemia
10%Skin + Subcutaneous tissue disorder (foot ulcer)
10%White Blood Cell Decreased
10%Hypermagnesemia
10%Watering Eyes
10%Peripheral Sensory Neuropathy
10%Productive Cough
10%Urinary urgency
10%Urinary tract infection
10%Rash Acneiform
10%Weight Loss
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
1 Treatment Group
Radiation therapy (RT)
1 of 1
Experimental Treatment
28 Total Participants · 1 Treatment Group
Primary Treatment: Radiation Therapy (RT) · No Placebo Group · N/A
Radiation therapy (RT)
Radiation
Experimental Group · 1 Intervention: Radiation Therapy (RT) · Intervention Types: RadiationTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radiation Therapy (RT)
2008
Completed Phase 2
~190
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months
Who is running the clinical trial?
University of California, San FranciscoLead Sponsor
2,347 Previous Clinical Trials
11,783,084 Total Patients Enrolled
Varian Medical SystemsIndustry Sponsor
47 Previous Clinical Trials
3,434 Total Patients Enrolled
Mary Feng, MDPrincipal InvestigatorUniversity of California, San Francisco
2 Previous Clinical Trials
53 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are expected to live for at least 6 more months.
Frequently Asked Questions
How many subjects have enrolled in this clinical investigation?
"Absolutely, the information posted on clinicaltrials.gov indicates that this research is currently recruiting participants. The study was initially uploaded on August 7th 2020 and modified most recently in November 7th 2022. For now, 28 subjects are being recruited at a single site." - Anonymous Online Contributor
Unverified Answer
Are new participants being sought out at this point in time for the clinical trial?
"Affirmative. Clinicaltrials.gov demonstrates that the search for participants is ongoing, beginning on August 7th 2020 and last updated on November 7th 2022. Altogether 28 people need to join from a single site." - Anonymous Online Contributor
Unverified Answer