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Clinical Stage III Gastric Cancer AJCC v8Phase 2NCT04660760

Ramucirumab and Trifluridine/Tipiracil or Paclitaxel for the Treatment of Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Cancer

A Phase 2 study testing Paclitaxel, Quality-of-Life Assessment and Ramucirumab in people with Clinical Stage III Gastric Cancer AJCC v8 and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, run by Academic and Community Cancer Research United at 9 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Paclitaxel, Quality-of-Life Assessment and Ramucirumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
9 sitesUnited States
Study dates
16 Jun 2021to 30 Nov 2026
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

  • Age >= 18 years
  • Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction
  • Have locally advanced unresectable or metastatic disease that has progressed =< 180 days since last treatment
  • One or more measurable or nonmeasurable evaluable lesions per Response Evaluation Criteria in Solid Tumors (RECIST)
  • Planned for second line treatment defined by failing or were intolerant to previous standard chemotherapies containing one or more of the following agents:
  • Fluoropyrimidine (IV 5-FU or capecitabine) and platinum (cisplatin or oxaliplatin)
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  • Trastuzumab in case of HER2-positive disease
  • NOTE: For the patients whose disease recurred =< 168 days from the last dose of adjuvant anticancer chemotherapy, that adjuvant anticancer chemotherapy is counted as 1 prior chemotherapy line
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
  • Ability to swallow oral medications
  • Absolute neutrophil count (ANC) >= 1500/mm^3 (obtained =< 7 days prior to registration)
  • Platelet count >= 100,000/mm^3 (obtained =< 7 days prior to registration)
  • Hemoglobin >= 9.0 g/dL (obtained =< 7 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (obtained =< 7 days prior to registration)
  • Aspartate transaminase (AST) and alanine transaminase (ALT) =< 3 x ULN ( =< 5.0 x UNL, if with liver metastasis) (obtained =< 7 days prior to registration)
  • International normalized ratio (INR) =< 1.5 x ULN, and a partial thromboplastin time (PTT) =< 5 seconds above the ULN (unless receiving anticoagulation therapy) (obtained =< 7 days prior to registration)
  • Note: Patients receiving warfarin must be switched to low molecular weight heparin and have achieved stable coagulation profile prior to first dose of protocol therapy
  • Note: Patients on full-dose anticoagulation must be on a stable dose (minimum duration 14 days) of oral anticoagulant or low molecular weight heparin (LMWH)
  • Exception: If receiving warfarin, the patient must have an INR =< 3.0. For heparin and LMWH there should be no active bleeding (that is, no bleeding within 14 days prior to first dose of protocol therapy) or pathological condition present that carries a high risk of bleeding (for example, tumor involving major vessels or known varices)
  • Urinary protein is =< 1+ on dipstick or routine urinalysis (UA; if urine dipstick or routine analysis is >= 2+, a 24-hour urine collection for protein must demonstrate =< 1000 mg of protein in 24 hours to allow participation in this protocol) (obtained =< 7 days prior to registration)
  • Creatinine =< 1.5 times the ULN or creatinine clearance (measured via 24-hour urine collection) >= 50 mL/minute (that is, if serum creatinine is >= 1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed) (obtained =< 7 days prior to registration)
  • Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Provide informed written consent =< 28 days prior to registration
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Because the teratogenicity of ramucirumab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods)

Who cannot join

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
  • Pregnant women
  • Nursing women
  • Women of childbearing potential who are unwilling to employ adequate contraception
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Previous treatment with TAS-102 or ramucirumab
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  • Previous taxane therapy =< 180 days prior to registration
  • Any grade 3-4 gastrointestinal (GI) bleeding =< 90 days prior to registration
  • History of deep vein thrombosis (DVT), pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered "significant") =< 90 days prior to registration
  • Any arterial thromboembolic events, including but not limited to myocardial infarction, transient ischemic attack, cerebrovascular accident, or unstable angina, =< 180 days prior to registration
  • Prior history of GI perforation/fistula =< 180 days of registration or risk factors for perforation
  • Serious or nonhealing wound, ulcer, or bone fracture =< 28 days prior to registration
  • Major surgery =< 28 days prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement =< 7 days prior to registration
  • Elective or planned major surgery to be performed during the course of the clinical trial
  • Cirrhosis at a level of Child-Pugh B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. NOTE: Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
  • Uncontrolled or poorly-controlled hypertension (>= 150 mmHg systolic or >= 90 mmHg diastolic for >= 4 weeks) despite standard medical management
  • Immunocompromised and known to be human immunodeficiency virus (HIV) positive and currently receiving antiretroviral therapy
  • NOTE: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm
  • Other active malignancy =< 3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer
  • Receiving chronic antiplatelet therapy, including dipyridamole or clopidogrel, or similar agents. NOTE: Once-daily aspirin use (maximum dose 325 mg/day) is permitted

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Vanderbilt University/Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

  • Cleveland Clinic-Weston

    Weston, Florida, 33331

Other trials in United States

About this study

Official title: Ramucirumab Plus Trifluridine/Tipiracil (TAS-102) for Patients With Previously Treated Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: An Investigator-Initiated, Randomized Non-Inferiority Phase 2 Study

This phase II trial studies the effect of the combination of ramucirumab and trifluridine/tipiracil or paclitaxel in treating patients with previously treated gastric or gastroesophageal junction cancer that has spread to other places in the body (advanced). Ramucirumab may damage tumor cells by targeting new blood vessel formation. Trifluridine/tipiracil is a chemotherapy pill and that may damage tumor cells by damaging their deoxyribonucleic acid (DNA). Paclitaxel may block cell growth by stopping cell division which may kill tumor cells. Giving ramucirumab and trifluridine/tipiracil will not be worse than ramucirumab and paclitaxel in treating gastric or gastroesophageal junction cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare, in a non-inferiority fashion, the progression-free survival (PFS) in patients with metastatic refractory gastric/gastroesophageal junction (GEJ) adenocarcinoma receiving the combination of ramucirumab with trifluridine and tipiracil hydrochloride (TAS-102) versus (vs.) paclitaxel and ramucirumab.

SECONDARY OBJECTIVES:

  1. To assess overall survival (OS) in this patient population for each regimen. II. Assess changes in patient quality of life (QOL) as measured by the linear analogue self-assessment (LASA) questionnaire for each regimen.

III. To determine the safety of the combination of ramucirumab with TAS-102 in this patient population.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive TAS-102 orally (PO) twice daily (BID) on days 1-5 and 8-12, and ramucirumab intravenously (IV) over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

ARM B: Patients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30-35 days, then every 3 months for up to 3 years.

Being tested
Paclitaxel, Quality-of-Life Assessment, Ramucirumab, Trifluridine and Tipiracil Hydrochloride

What participants receive

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

  • PaclitaxelDrug

    Also called Anzatax, Asotax, Bristaxol, Praxel

    Given IV

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Complete questionnaires

  • RamucirumabBiological

    Also called Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806

    Given IV

  • Trifluridine and Tipiracil HydrochlorideDrug

    Also called Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine

    Given PO

Study groups in NCT04660760
Study groupRoleWhat they receive
Arm A (TAS-102, ramucirumab)ExperimentalPatients receive TAS-102 PO BID on days 1-5 and 8-12, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Other: Quality-of-Life Assessment; Biological: Ramucirumab; Drug: Trifluridine and Tipiracil Hydrochloride
Arm B (paclitaxel, ramucirumab)Active comparatorPatients receive paclitaxel IV over 1-96 hours on days 1, 8, and 15, and ramucirumab IV over 30-60 minutes on days 1 and 15. Treatment repeats every 28 days for up to 36 cycles in the absence of disease progression or unacceptable toxicity.
Receives: Drug: Paclitaxel; Other: Quality-of-Life Assessment; Biological: Ramucirumab

What is being measured

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

  1. Progression-free Survival

    Progression free survival is defined as the time interval between randomization date and the date of disease progression or death (referred to as an "event"), whichever occurs first. Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. The median progression free survival will be estimated using the Kaplan-Meier method for each arm, corresponding 95% confidence intervals will be reported.

    Measured: 1 year

Secondary outcomes (3)

  1. Overall Survival (OS)

    Median OS will be estimated using the Kaplan-Meier method. Patients who do not experience death while on study will be censored at the last known date alive. The median OS and corresponding 95% confidence interval will be reported by arm.

    Measured: 3 years

  2. Quality of Life (QOL)

    Patient reported QOL outcomes will be collected using the Linear Analog Self-Assessment (LASA) Questionnaire. Data will be collected each cycle. Mean values of the first question (regarding overall QOL) at each cycle will be plotted, and stratified by arm. Patient-reported quality of life was assessed using Question 1 of the Linear Analog Scale Assessment (LASA) of Quality of Life, which assesses overall quality of life over the past week on a scale from 0 to 10, where 0 represents the worst possible quality of life and 10 represents the best possible quality of life. Higher scores indicate better quality of life. Mean scores were calculated at each cycle and reported by treatment arm.

    Measured: Up to approximately 8 months

  3. Incidence of Adverse Events

    Adverse events will be recorded using Common Terminology Criteria for Adverse Events version 5.0. The percentage of patients who experience a grade 3+ adverse event at least possibly related to treatment will be reported by arm.

    Measured: 1 year

Timeline

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

  1. First posted9 Dec 2020
  2. Study start16 Jun 2021
  3. Primary completion15 Sep 2025
  4. Study completion30 Nov 2026 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04660760
Sponsor's protocol ID
ACCRU-GI-1810
Other IDs
NCI-2020-11436, ACCRU-GI-1810, P30CA015083
Status last verified
Oct 2026
First submitted
3 Dec 2020
Last updated
5 Nov 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel, Quality-of-Life Assessment and Ramucirumab in people with Clinical Stage III Gastric Cancer AJCC v8 and Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, run by Academic and Community Cancer Research United at 9 sites 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 26 inclusion and 22 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: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 5 Nov 2026). 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?

Progression-free Survival (time frame: 1 year). 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 NCT04660760.

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 5 Nov 2026.

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