ClinicalTrials.gg
Active, not recruitingNCT04660760Updated Nov 5, 2026Results posted

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

A Phase 2 interventional study of Paclitaxel and Quality-of-Life Assessment in Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8, sponsored by Academic and Community Cancer Research United. Active, not recruiting at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by Academic and Community Cancer Research United · Phase 2, Interventional, and Treatment

Updated Nov 5, 2026Now Active, not recruitingResults posted+6 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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:

I. 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:

I. 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.

02

Conditions studied

  • Clinical Stage III Gastric Cancer AJCC v8
  • Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IV Gastric Cancer AJCC v8
  • Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVA Gastric Cancer AJCC v8
  • Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Clinical Stage IVB Gastric Cancer AJCC v8
  • Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Locally Advanced Unresectable Gastric Adenocarcinoma
  • Locally Advanced Unresectable Gastroesophageal Junction Adenocarcinoma
  • Metastatic Gastric Adenocarcinoma
  • Metastatic Gastroesophageal Junction Adenocarcinoma
  • Pathologic Stage III Gastric Cancer AJCC v8
  • Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIA Gastric Cancer AJCC v8
  • Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIB Gastric Cancer AJCC v8
  • Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IIIC Gastric Cancer AJCC v8
  • Pathologic Stage IV Gastric Cancer AJCC v8
  • Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage III Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastric Cancer AJCC v8
  • Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8
  • Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8

Browse trials for

03

In context

Stomach Neoplasms

3,399 studies on the registry are indexed under Stomach Neoplasms; 992 are open to participants now.

This study's enrollment of 34 is below the median of 66 across 2,499 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Academic and Community Cancer Research United is the lead sponsor of 50 studies on the registry; 4 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 12 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age >= 18 years
  • Histological or cytological confirmation of adenocarcinoma of the stomach or gastroesophageal junction
  • Have locally advanced unresectable or disease that has progressed =\< 180 days since last treatment
  • One or more measurable or nonmeasurable evaluable lesions per (RECIST)
  • Planned for 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)
    • Trastuzumab in case of -positive disease
    • NOTE: For the patients whose disease recurred =\< 168 days from the last dose of anticancer chemotherapy, that adjuvant anticancer chemotherapy is counted as 1 prior chemotherapy line
  • (ECOG) performance status (PS) 0 or 1
  • Ability to swallow oral medications
  • (ANC) >= 1500/mm\^3 (obtained =\< 7 days prior to registration)
  • count >= 100,000/mm\^3 (obtained =\< 7 days prior to registration)
  • >= 9.0 g/dL (obtained =\< 7 days prior to registration)
  • Total =\< 1.5 x (ULN) (obtained =\< 7 days prior to registration)
  • (AST) and alanine transaminase (ALT) =\< 3 x ULN ( =\< 5.0 x UNL, if with liver metastasis) (obtained =\< 7 days prior to registration)
  • (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 (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 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 , surgically sterile, or using effective (hormonal or barrier methods)

Exclusion criteria

Exclusion Criteria:

  • Any of the following because this study involves an agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:

    • Pregnant women
    • Nursing women
    • Women of who are unwilling to employ adequate
  • 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
  • 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, , 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 B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or 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
  • and known to be (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 =\< 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
Terms in these criteria, in plain language(24)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

RECIST

The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

HER2

HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.

In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (actual)

Study arms

  • Experimental
    Arm A (TAS-102, ramucirumab)

    Patients 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.

    Other: Quality-of-Life Assessment · Biological: Ramucirumab · Drug: Trifluridine and Tipiracil Hydrochloride

  • Active comparator
    Arm B (paclitaxel, ramucirumab)

    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.

    Drug: Paclitaxel · Other: Quality-of-Life Assessment · Biological: Ramucirumab

Interventions

  • Given IV

    Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

  • OtherQuality-of-Life Assessment

    Complete questionnaires

    Also known as: Quality of Life Assessment

  • BiologicalRamucirumab

    Given IV

    Also known as: Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, LY3009806, Monoclonal Antibody HGS-ETR2

  • DrugTrifluridine and Tipiracil Hydrochloride

    Given PO

    Also known as: Lonsurf, TAS 102, TAS-102, Tipiracil Hydrochloride Mixture with Trifluridine, Trifluridine/Tipiracil, Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102

06

What researchers measure

Primary outcomes

  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.

    Time frame: 1 year

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 1 year

07

Results

Posted Nov 5, 2026

Participant flow

Participant flow — Overall Study
MilestoneArm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)
Started1717
Completed1514
Not completed23
Withdrew: Cancel23

Outcome measures

PrimaryProgression-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.

Time frame:
1 year
Reported as:
Median · Months
Progression-free Survival
MonthsArm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)
Progression-free Survival3.2 (1.8 to NA)3.9 (2.8 to NA)
SecondaryOverall 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.

Time frame:
3 years
Reported as:
Median · Months
Overall Survival (OS)
MonthsArm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)
Overall Survival (OS)8.4 (3.5 to NA)10.7 (7.3 to NA)
SecondaryQuality 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.

Time frame:
Up to approximately 8 months
Reported as:
Mean · score on a scale
Quality of Life (QOL)
score on a scaleArm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)
Cycle 07.5 ± 2.177.8 ± 1.86
Cycle 17.4 ± 2.147.6 ± 1.89
Cycle 26.4 ± 2.557.4 ± 2.54
Cycle 38.8 ± 1.507.7 ± 1.51
Cycle 48.3 ± 0.587.3 ± 1.37
Cycle 55.0 ± 4.248.3 ± 0.5
Cycle 68 ± 08 ± 0.82
Cycle 78 ± NA8 ± 1.41
Cycle 88 ± NA8.5 ± 0.71
SecondaryIncidence 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.

Time frame:
1 year
Reported as:
Number · percentage of patients
Incidence of Adverse Events
percentage of patientsArm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)
Incidence of Adverse Events60.057.1

Adverse events

Collected over adverse events for 1 year and mortality for 3 years. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm A (TAS-102, Ramucirumab)11/15 (73.3%)7/15 (46.7%)14/15 (93.3%)
Arm B (Paclitaxel, Ramucirumab)8/14 (57.1%)4/14 (28.6%)13/14 (92.9%)
Most frequent serious events
Showing 10 of 33
Most frequent serious events
EventArm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)
AnorexiaMetabolism and nutrition disorders3/150/14
Abdominal painGastrointestinal disorders2/151/14
NauseaGastrointestinal disorders2/151/14
VomitingGastrointestinal disorders2/151/14
DehydrationMetabolism and nutrition disorders2/151/14
AscitesGastrointestinal disorders0/151/14
Gastric perforationGastrointestinal disorders1/151/14
Death NOSGeneral disorders and administration site conditions0/151/14
Edema trunkGeneral disorders and administration site conditions0/151/14
FatigueGeneral disorders and administration site conditions1/151/14
Most frequent other events
Showing 10 of 69
Most frequent other events
EventArm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)
Peripheral sensory neuropathyNervous system disorders7/1512/14
AnemiaBlood and lymphatic system disorders12/1511/14
NauseaGastrointestinal disorders10/156/14
HypertensionVascular disorders10/157/14
VomitingGastrointestinal disorders8/151/14
Neutrophil count decreasedInvestigations8/155/14
ProteinuriaRenal and urinary disorders6/157/14
Platelet count decreasedInvestigations7/153/14
White blood cell decreasedInvestigations7/153/14
FatigueGeneral disorders and administration site conditions5/156/14

Baseline characteristics

All treated patients

Age, Continuous
Age, Continuous(years)Arm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)Total
Mean62.1 ± 9.9360.0 ± 13.1761.1 ± 11.44
Sex: Female, Male
Sex: Female, Male(Participants)Arm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)Total
Female325
Male121224
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Arm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)Total
Hispanic or Latino257
Not Hispanic or Latino13922
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Arm A (TAS-102, Ramucirumab)Arm B (Paclitaxel, Ramucirumab)Total
American Indian or Alaska Native101
Asian022
Native Hawaiian or Other Pacific Islander000
Black or African American000
White131124
More than one race000
Unknown or Not Reported112
08

Study locations

9 sites
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Nov 5, 2026
Results
Results posted
posted Nov 5, 2026
Sites
6 sites removed
Show 6 removed
  • Arizona Clinical Research Center · Tucson, United States
  • Emory University Hospital/Winship Cancer Institute · Atlanta, United States
  • Carle Cancer Center NCI Community Oncology Research Program · Urbana, United States
  • Cancer Center of Kansas - Wichita · Wichita, United States
  • University of Nebraska Medical Center · Omaha, United States
  • Aurora Cancer Care-Milwaukee West · Wauwatosa, United States
Nov 5, 2026
Primary completion
Jul 31, 2024→Sep 15, 2025 (actual)
Nov 5, 2026
Study completion
May 31, 2026→Nov 30, 2026
Nov 5, 2026
Enrollment
116 (estimated)→34 (actual)
Nov 5, 2026
Primary outcomes
1 edited
What changed in the outcomes
  • EditedProgression-free survivalSurvivalTime frame: Up to 1 year → 1 year
Nov 5, 2026
Secondary outcomes
3 edited
What changed in the outcomes
  • EditedOverall survivalSurvival (OS)Time frame: Up to 3 years → 3 years
  • EditedQuality of lifeLife (QOL)Time frame: Up to 3 years → Up to approximately 8 months
  • EditedIncidence of adverse eventsAdverse EventsTime frame: Up to 3 years → 1 year
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Recruiting→Active, not recruiting
    Results posted
    6 sites removed
    Show 6 removed
    • Arizona Clinical Research Center · Tucson, United States
    • Emory University Hospital/Winship Cancer Institute · Atlanta, United States
    • Carle Cancer Center NCI Community Oncology Research Program · Urbana, United States
    • Cancer Center of Kansas - Wichita · Wichita, United States
    • University of Nebraska Medical Center · Omaha, United States
    • Aurora Cancer Care-Milwaukee West · Wauwatosa, United States
    Primary completion Jul 31, 2024→Sep 15, 2025 (now actual)
    Study completion May 31, 2026→Nov 30, 2026
    Enrollment 116 (estimated)→34 (actual)
    Primary outcomes 1 edited
    What changed in the outcomes
    • EditedProgression-free survivalSurvivalTime frame: Up to 1 year → 1 year
    Secondary outcomes 3 edited
    What changed in the outcomes
    • EditedOverall survivalSurvival (OS)Time frame: Up to 3 years → 3 years
    • EditedQuality of lifeLife (QOL)Time frame: Up to 3 years → Up to approximately 8 months
    • EditedIncidence of adverse eventsAdverse EventsTime frame: Up to 3 years → 1 year
    + 3 other changes: verification date, contact details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

11

Registry details

Key details

Study ID
NCT04660760
Lead sponsor
Academic and Community Cancer Research United
Responsible party
Sponsor
First posted
Dec 9, 2020
Start date
Jun 16, 2021
Primary completion
Sep 15, 2025
Completion
Nov 30, 2026 (estimated)
Results posted
Nov 5, 2026
Last update
Nov 5, 2026

Study contacts

Mohamad B Sonbol
principal investigator · Academic and Community Cancer Research United

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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