Study Summary
This trial is testing if cryoablation, a treatment to kill cancer cells with extreme cold, combined with a current immune checkpoint inhibitor, is an effective treatment for lung cancer.
Eligible Conditions
- Lung Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 2 years
2 years
Therapeutic procedure
Radiologic Response Rate Of Cryoablation
Trial Safety
Safety Progress
Side Effects for
3/Arm B - Tremelimumab + TACE
100%Hyponatremia
92%Hypoalbuminemia
92%Lymphocyte count decreased
92%Anemia
83%Alkaline phosphatase increased
83%Alanine aminotransferase increased
83%Aspartate aminotransferase increased
75%Activated partial thromboplastin time prolonged
75%Hypophosphatemia
67%Nausea
67%Fatigue
67%Constipation
67%Pain
67%Blood bilirubin increased
58%Fever
58%Insomnia
50%Abdominal pain
50%Diarrhea
50%Creatinine increased
50%Serum amylase increased
42%Hypokalemia
42%Hyperkalemia
42%Anorexia
42%Cough
42%Rash maculo-papular
42%Hypercalcemia
42%Platelet count decreased
25%Dehydration
25%Vomiting
25%Hypocalcemia
25%Ascites
25%Back pain
25%Hypomagnesemia
17%Edema limbs
17%Colitis
17%Hypermagnesemia
17%Weight loss
17%Neutrophil count decreased
17%Confusion
17%Bloating
17%Hypotension
17%Hypernatremia
17%Blurred vision
17%Gastrointestinal disorders - Other, gastrointestinal disorders - Other, cramping
17%Lipase increased
17%Headache
17%Dizziness
17%Dyspnea
17%Hyperhidrosis
8%Papulopustular rash
8%Peripheral motor neuropathy
8%Bronchial infection
8%Edema trunk
8%Flushing
8%Ileus
8%Myalgia
8%Pneumothorax
8%Skin and subcutaneous tissue disorders - Other, skin discoloration
8%Gastroesophageal reflux disease
8%Palpitations
8%Skin and subcutaneous tissue disorders - Other, skin peeling - bil. Hands
8%Malaise
8%Hypoxia
8%Hiccups
8%Skin infection
8%Atrial fibrillation
8%Intra-abdominal hemorrhage
8%Gastrointestinal disorders - Other, Inguinal hernia
8%Muscle weakness left-sided
8%Abdominal distension
8%Hypertension
8%Alopecia
8%Adrenal insufficiency
8%Anxiety
8%Allergic rhinitis
8%Dysgeusia
8%Erectile dysfunction
8%Hypothyroidism
8%Flu like symptoms
8%Skin hyperpigmentation
8%Urinary frequency
8%Hoarseness: voice changes
8%Lung infection
8%Depression
8%Dry mouth
8%Gastric ulcer
8%Palmar-plantar erythrodysesthesia syndrome
8%Vertigo
8%Hyperthyroidism
8%Dry skin
8%Infections and infestations - Other, C. Diff infection
8%Generalized muscle weakness
8%Seizure
8%CPK increased
8%Dry eye
8%Atrial flutter
8%Hypersomnia
8%Respiratory, thoracic and mediastinal disorders - Other, Pneumonia
8%Epistaxis
8%Sore throat
8%Rash acneiform
Trial Design
1 Treatment Group
CT-guided Percutaneous Cryoablation of Lung Tumor
1 of 1
Experimental Treatment
20 Total Participants · 1 Treatment Group
Primary Treatment: Cryoablation · No Placebo Group · N/A
CT-guided Percutaneous Cryoablation of Lung TumorExperimental Group · 2 Interventions: Cryoablation, Biopsy · Intervention Types: Procedure, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cryoablation
2016
Completed Phase 2
~930
Biopsy
2014
Completed Phase 4
~1120
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,703 Previous Clinical Trials
30,853,188 Total Patients Enrolled
William M. Wood FoundationUNKNOWN
Meghan J Mooradian, MDPrincipal InvestigatorMassachusetts General Hospital
Eligibility Criteria
Age 18+ · All Participants · 3 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Adult patients with stage IV lung cancer who are receiving commercial supply immune checkpoint inhibitor therapy and who have progressed may continue to do so for an additional four to six weeks
The tumor must be measurable, meaning that there must be at least one lesion that meets the following criteria: it can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan, MRI, or calipers by clinical exam
The text suggests that the tumor must be growing and that it should be amenable to percutaneous cryoablation, a procedure that is carried out by an interventional radiologist.
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Conditions
Cancer Related
Treatments