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Ramucirumab (Cyramza), Nal-IRI (ONIVYDE) and Trifluridine/Tipiracil (Lonsurf) in Second Line Metastatic Gastric Cancer .

ConditionsMetastatic Gastric AdenocarcinomaSecond LineChemotherapy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNational Health Research Institutes, Taiwan

About this trial

Primary Objectives

* In phase 1b cohort, to determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE®) in combination with Ramucirumab (Cyramza®) and TAS-102 (LONSURF®) * In phase II cohort, to evaluate disease objective response rate (ORR) of Ramucirumab (Cyramza®), nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) Secondary Objectives * To evaluate disease control rate (DCR) * To evaluate progression-free survival (PFS) * To evaluate overall survival (OS) * To assess the safety profile * To study the blood biomarkers

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

histologically or cytologically confirmed metastatic gastric adenocarcinoma

patients have received only first line of systemic therapy, including recurrence during adjuvant therapy or within 6 months after the completion of adjuvant treatment.

ECOG(Eastern Cooperative Oncology Group) performance status 0 or 1

patients with HER2/neu-positive tumor must be exposure to Herceptin treatment

Disqualifiers

patient can't take oral drugs;

known hypersensitivity to irinotecan, fluoropyrimidine, or ramucirumab;

receipt of surgery within the past 4 weeks before study enrollment;

≥ grade 2 diarrhea and ascites

Trial design

Design model

Single group

Treatments tested in this trial

  • nal-IRI /Experimental

    Drug

    infusional 50/60/70 mg/m2 over 90 minutes day 1, every 14 days.

  • Ramucirumab /Experimental

    Drug

    infusional 8mg/kg over 60 minutes day 1, every 14 days.

  • Trifluridine/Tipiracil /Experimental

    Drug

    oral 30 mg/m2/b.i.d. day 1-5, every 14 days.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Phase 1b/IIExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

To determine MTD (maximum tolerated dose) of nal-IRI (ONIVYDE)

All treated patients of MTD dose level in phase 1b cohort will be incorporated into phase II cohort for final analysis.

Time frame
Phase I last patient in has been treated for 28 days.
2

To evaluate disease objective response rate (ORR)

Based on results from phase Ib cohort, MTD will be determined. All treated population in MTD cohort will be incorporated into phase II cohort for final analysis.

Time frame
Whichever occurs first assessed up to 24 months.

Secondary outcomes

1

•To evaluate disease control rate (DCR)

•Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the off-study criteria.

Time frame
The time from registration to death from any cause assessed up to 24 months.
2

•To evaluate progression-free survival (PFS)

• objective tumor response according to RECIST v1.1 guidelines.

Time frame
The time from registration to occurrence of progression based on the tumor response assessment by scheduled or un- scheduled CT scan or MRI. (whichever occurs first assessed up to 24 months)
3

•To evaluate overall survival (OS)

the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive.

Time frame
The time from registration to death from any cause assessed up to 24 months.
4

•To assess the safety profile

•Safety evaluations: physical examination, vital signs, body weight, ECOG performance status, clinical laboratory values (biochemistry, hematology, and urinalysis), and any adverse event (AE) graded by using CTCAE v5.0 if applicable.

Time frame
The time from registration to death from every 14 days assessed up to 24 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Health Research Institutes, Taiwan

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Collaborator

China Medical University Hospital

Collaborator

National Cheng-Kung University Hospital

Collaborator

Kaohsiung Medical University Chung-Ho Memorial Hospital

Collaborator

Chang Gung Memorial Hospital

Collaborator

Source ClinicalTrials.gov
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