← Back to Search

Monoclonal Antibodies

TAS 102 + Ramucirumab for Stomach Cancer

Phase 2
Waitlist Available
Led By Dae W Kim, MD
Research Sponsored by H. Lee Moffitt Cancer Center and Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable or non-measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Stage IV or recurrent disease is required. An irradiated lesion is considered evaluable only if it has shown enlargement since the completion of last radiation
Participants must have received and progressed with prior therapy. Prior therapy with ramucirumab is not allowed. Participants must have recovered from the toxic effects of the previous anti-cancer chemotherapy (with the exception of alopecia)
Must not have
Women who are pregnant or breast-feeding
Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after end of study participation, an average of 6.5 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new combination therapy for stomach cancer that has progressed despite treatment. The goal is to see if it is safe and effective.

Who is the study for?
This trial is for adults with advanced, refractory gastric or gastroesophageal junction adenocarcinoma who've had prior therapy but not with ramucirumab. They must have a life expectancy over 3 months, good organ function, and no recent major surgeries or other cancer treatments. Women of childbearing age need a negative pregnancy test and all participants must agree to use contraception.
What is being tested?
The study tests the safety and effectiveness of combining TAS 102 with Ramucirumab (CYRAMZA) in treating stomach cancer that hasn't responded to previous therapies. It aims to find out if this drug combination can help patients with this specific type of cancer.
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, low blood cell counts leading to increased infection risk or bleeding problems. Ramucirumab might cause high blood pressure, bleeding issues, or infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer is at stage IV or has come back and can be measured by specific criteria.
Select...
I have had cancer treatment before, but not with ramucirumab, and have recovered from side effects.
Select...
I am fully active or can carry out light work.
Select...
My diagnosis is stomach or GEJ cancer confirmed by tissue analysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am not pregnant or breast-feeding.
Select...
I have not had severe bleeding in the last 4 weeks.
Select...
My cancer has spread to my brain.
Select...
I have been treated with specific medications before.
Select...
My high blood pressure is not under control.
Select...
I have heart-related health issues.
Select...
I cannot swallow pills or have certain stomach/intestine problems.
Select...
I have severe, ongoing protein in my urine.
Select...
I have severe liver disease or have had swelling of the brain due to liver failure.
Select...
I have not had major surgery or any unhealed wounds in the last 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after end of study participation, an average of 6.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after end of study participation, an average of 6.5 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
Overall Survival
Secondary study objectives
Number of Participants With at Least One Adverse Event
Objective Response Rate
Progression Free Survival (PFS)

Side effects data

From 2024 Phase 2 trial • 23 Patients • NCT03686488
61%
Fatigue
57%
Diarrhea
57%
Nausea
52%
Vomiting
48%
Headache
39%
Hypertension
26%
Dizziness
26%
Neutrophil count decreased
26%
Anorexia
26%
Dyspnea
26%
Constipation
22%
General disorders and administration site conditions - Other
22%
Anemia
22%
Gastrointestinal disorders -Other
17%
White blood cell decreased
17%
Cough
17%
Abdominal pain
17%
Chills
17%
Pain
13%
Epistaxis
13%
Injury, poisoning and procedural complications - Other
13%
Flank pain
13%
Death NOS
13%
Lymphocyte count decreased
13%
Toothache
13%
Edema limbs
13%
Non-cardiac chest pain
9%
Hyponatremia
9%
Weight loss
9%
Hoarseness
9%
Nervous system disorders - Other
9%
Ascites
9%
Flu like symptoms
9%
Weight gain
9%
Dysphagia
9%
Platelet count decreased
4%
Reproductive system and breast disorders - Other,
4%
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
4%
Hypotension
4%
Hyperglycemia
4%
Alopecia
4%
Fall
4%
Anxiety
4%
Blurred vision
4%
Renal colic
4%
Palpitations
4%
Urine discoloration
4%
Hematuria
4%
Atrial fibrillation
4%
Stroke
4%
Blood bilirubin increased
4%
Lipase increased
4%
Thromboembolic event
4%
Skin infection
4%
Aspartate aminotransferase increased
4%
Muscle weakness lower limb
4%
Shingles
4%
Bronchial infection
4%
Pericardial effusion
4%
Electrocardiogram QT corrected interval prolonged
4%
Pain in extremity
4%
Restlessness
4%
Arthralgia
4%
Myalgia
4%
Peripheral sensory neuropathy
4%
Dry mouth
4%
Hemorrhoids
4%
Upper gastrointestinal hemorrhage
4%
Multi-organ failure
4%
Pleural effusion
4%
Productive cough
4%
Respiratory, thoracic and mediastinal disorders - Other
4%
Sudden death NOS
4%
Infections and infestations- Other
4%
Colonic hemorrhage
4%
Stomach pain
4%
Dental caries
4%
Dyspepsia
4%
Oral hemorrhage
4%
Alanine aminotransferase increased
4%
Fever
4%
Hypokalemia
4%
Infections and infestations - Other
4%
Psychiatric disorders - Other
4%
Proteinuria
4%
Urinary frequency
4%
Dry skin
4%
Skin and subcutaneous tissue disorders - Other
4%
Ear and labyrinth disorders - Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
TAS 102 and Ramucirumab

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: TAS 102 and RamucirumabExperimental Treatment2 Interventions
TAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAS 102
2017
Completed Phase 3
~500
Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]
2018
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
567 Previous Clinical Trials
144,896 Total Patients Enrolled
Dae W Kim, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
1 Previous Clinical Trials
52 Total Patients Enrolled

Media Library

Ramucirumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03686488 — Phase 2
Stomach Cancer Research Study Groups: TAS 102 and Ramucirumab
Stomach Cancer Clinical Trial 2023: Ramucirumab Highlights & Side Effects. Trial Name: NCT03686488 — Phase 2
Ramucirumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03686488 — Phase 2
~3 spots leftby Jan 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top