A Single-Center Randomized Superiority Exploratory Study of the Efficacy of Fosnetupitant as Antiemetic Therapy in Combination Therapy with nal-IRI+5-FU/l-LV in Patients with Unresectable Pancreatic Cancer

A Single-Center Randomized Superiority Exploratory Study of the Efficacy of Fosnetupitant, an NK1 Receptor Antagonist, as Antiemetic Therapy in Combination Therapy with Nanoliposomal Irinotecan (nal-IRI)+5-FU/l-LV in Patients with Unresectable Pancreatic Cancer - Frontier Study

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1051240032

Enrollment

Registered

2024-05-13

Start date

2024-04-25

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable advanced pancreatic cancer

Interventions

Randomization

Fosnetupitant

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Diagnosis of adenocarcinoma or adenosquamous carcinoma on tissue biopsy or cytology, and imaging studies are consistent with pancreatic cancer. 2) Diagnosis of unresectable due to locally advanced (UR-LA) or distant metastasis (UR-M) is made by imaging from the chest to pelvic region, including MDCT. 3) The first dose of nal-IRI+5-FU/l-LV is planned as second line chemotherapy. 4) No uncontrolled pleural effusions or ascites on imaging. 5) No diarrhea greater than CTCAE Grade 2. 6) Age is 20 years or older. 7) ECOG performance status of 2 or below. 8) Estimated survival more than three months. 9) No severe organ dysfunction. 10) Written informed consent are obtained.

Exclusion criteria

Exclusion criteria: 1) History of hypersensitivity to the drugs used in this study. 2) Pregnant or possibly pregnant. 3) Severe comorbidities [such as heart failure, renal failure, hepatic failure, paresis of intestine, illeus, poorly controlled diabetes(HbA1c>=10%)]. 4) Complicated by unstable angina pectoris or has a history of myocardial infarction or cerebral infarction within 6 months. 5) Active other organ cancer that cannot be cured. 6) Has an infectious disease requiring systemic treatment. 7) Severe psychiatric disease. 8) Continuous systemic medication of corticosteroid or immunosuppressant. 9) Active pulmonary fibrosis or interstitial pneumonia. 10) Patients who are judged to be ineligible by investigators.

Design outcomes

Primary

Measure	Time frame
Overall (0-120 hours after initiation of nal-IRI) CR rate.	—

Secondary

Measure	Time frame
CR rate for each period after the start of nal-IRI administration Percentage of patients without nausea, CP rate, TC rate Percentage without vomiting Percentage without antiemetic treatment Duration of successful treatment Adverse events (including infection, elevated blood glucose, etc.) One-month follow-up survey on the occurrence of adverse events after the second course of nal-IRI+5-FU/l-LV therapy	—

Measure

Time frame

CR rate for each period after the start of nal-IRI administration Percentage of patients without nausea, CP rate, TC rate Percentage without vomiting Percentage without antiemetic treatment Duration of successful treatment Adverse events (including infection, elevated blood glucose, etc.) One-month follow-up survey on the occurrence of adverse events after the second course of nal-IRI+5-FU/l-LV therapy

—

Contacts

Public ContactYugo Kai

Department of Hepatobiliary and Pancreatic Oncology, Osaka International Cancer Institute

yugo.kai@oici.jp+81-6-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026