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

JRCT ID: jRCT1051240032

Registered date:13/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Unresectable advanced pancreatic cancer
• Date of first enrollment: 25/04/2024
• Target sample size: 58
• Study type: Interventional
• Intervention(s): Randomization

Outcome(s)

• Primary Outcome: Overall (0-120 hours after initiation of nal-IRI) CR rate.

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kai Yugo