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Gastric AdenocarcinomaPhase 2NCT03686488

TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

A Phase 2 study testing TAS 102 and Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA] in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to find out if the combination of TAS 102 and Ramucirumab is safe and effective in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TAS 102 and Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
20 Dec 2018to 31 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of gastric and GEJ adenocarcinoma.
  • 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).
  • Eastern Cooperative Oncology Group (ECOG) Performance score 0 or 1
  • Estimated life expectancy > 3 months
  • Adequate bone marrow, liver and renal function as assessed by the following: Hemoglobin > 8.0 g/dl, Absolute neutrophil count (ANC) > 1,000/mm3 independent of growth factor support, Platelet count > 100,000/mm3, Total bilirubin < 1.5 times upper limits of normal (ULN) unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin, aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline Phosphatase ≤2.5 times the ULN ( ≤5 x ULN for patients with liver involvement), Creatinine clearance ≥ 30 ml/min.
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  • Participants must not have had chemotherapy,major surgery, monoclonal antibody therapy or experimental therapy within the 28 days prior to the start of TAS 102 administration.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test.
  • Participants (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form until at least 4 months for both females and males after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
  • Participants must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements.

Who cannot join

  • Participants with active Central Nervous System (CNS) metastases are excluded. If CNS metastases are treated and participants are at neurologic baseline for at least 2 weeks prior to enrollment, they will be eligible but will need a Brain MRI prior to enrollment.
  • Women who are pregnant or breast-feeding.
  • Prior therapy with ramucirumab, bevacizumab, regorafenib or TAS 102.
  • Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder 15 tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Uncontrolled hypertension (systolic BP >140 mm Hg or diastolic BP >90 mm Hg on repeated measurement despite optimal medical management)
  • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
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  • Any hemorrhage or bleeding event ≥ NCI CTCAE Grade 3 within 4 weeks prior to start of study medication.
  • Persistent proteinuria ≥ Grade 3 on repeated measurement.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • Participants with an arterial thrombotic or thromboembolic event within 12 months of informed consent.
  • Ascites, pleural effusion, or pericardial fluid requiring drainage in the last 4 weeks
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection requiring treatment with antiviral therapy.
  • Clinically significant cardiovascular disease such as unstable angina, uncontrolled or symptomatic arrhythmia, congestive heart failure, any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or history of myocardial infarction within 6 months prior to first dose with study drug.
  • Unable to swallow capsules or disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption such as; malabsorption syndrome, resection of the small bowel, or poorly controlled inflammatory bowel disease affecting the small intestine.
  • Child-Pugh B cirrhosis (or worse) or a history of hepatic encephalopathy
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance in the study.
  • Major surgery or a wound that has not fully healed within 4 weeks of enrollment.
  • Patients who need anticancer chemotherapy other than the study drugs during the study or within 4 weeks of study enrollment. Anti-cancer therapy is defined as any agent or combination of agents with clinically proven anti-tumor activity administered by any route with the purpose of affecting the malignancy, either directly or indirectly, including palliative and therapeutic endpoints.
  • Patients who need hormonal therapy during the study or within 2 weeks of first study enrollment.
  • Patients who need radiotherapy to target lesions during study or within 2 weeks of enrollment.
  • Patients who had bone marrow transplant or stem cell rescue.
  • Patients who need investigational drug therapy outside of this trial during or within 4 weeks of first study treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: A Phase II Study of TAS 102 in Combination With Ramucirumab in Advanced, Refractory Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma

The purpose of this study is to find out if the combination of TAS 102 and Ramucirumab is safe and effective in patients with advanced, refractory gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Being tested
TAS 102, Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAS 102Drug

    Also called Lonsurf

    TAS 102 35 mg will be administered orally twice daily every 2 weeks.

  • Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]Drug

    Ramucirumab 8 milligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.

Study groups in NCT03686488
Study groupRoleWhat they receive
TAS 102 and RamucirumabExperimentalTAS 102 (Lonsurf) and Ramucirumab 10 MG/ML Intravenous Solution (CYRAMZA) administered concurrently.
Receives: Drug: TAS 102; Drug: Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall Survival

    Overall survival defined as the time from starting on trial to date of death from any cause.

    Measured: 6 months

Secondary outcomes (3)

  1. Number of Participants With at Least One Adverse Event

    Number of participants with at least one adverse event.

    Measured: 4 weeks after end of study participation, an average of 6.5 months

  2. Progression Free Survival (PFS)

    PFS, defined as the duration of time from start of treatment to time of progression or death, whichever comes first. Progression is evaluated using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Progressive Disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression.)

    Measured: 6 months

  3. Objective Response Rate

    Objective Response Rate is defined as complete response (CR) + partial response (PR) using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0). Complete Response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2018
  2. Study start20 Dec 2018
  3. Primary completion19 Jan 2022
  4. Study completion31 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03686488
Sponsor's protocol ID
MCC-19477
Status last verified
Feb 2026
First submitted
25 Sep 2018
Last updated
2 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kim DW, Kim RD, Jimenez MM, Kim Y, Mehta R. A phase II study of trifluridine/tipiracil in combination with ramucirumab in advanced, refractory gastric, or gastroesophageal junction adenocarcinomas. Oncologist. 2025 Dec 1;30(12):oyaf303. doi: 10.1093/oncolo/oyaf303.

    PubMed 41335458

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TAS 102 and Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA] in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Survival (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03686488, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.

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