NEPA Combined With Olanzapine, Dexamethasone-sparing for the Effect of CINV in Patients Receiving HEC Regimens

Inclusion criteria

• Male or female patients ≥18 years old
• Patients who receive the high-emetic-risk anticancer agents.
• Patients who do not take a medicine, for example, 5HT3 receptor antagonists, NK1 receptor antagonists, or research related agents, within 3 weeks prior to enrollment.
• No nausea or vomiting (grade II or above) within 72 hours before the start of chemotherapy.
• Subject has Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Subject has a life Expectation of at least 12 weeks.
• In accordance with the indication of chemotherapy and basic requirements： Peripheral haematology: Hb ≥9.0g/dL; absolute neutrophil count ≥1.5×109/L; Platelet count ≥80×109/L Blood biochemistry: Total bilirubin < 1.25×ULN, ALT and AST ≤ 2.5×ULN; If liver metastasis, ALT and AST < 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca) Other important organs function normally.
• Female patients of either non-childbearing potential or child-bearing potential use contraceptive methods throughout the clinical trial.
• Female patients with child-bearing potential must is negative of pregnancy test.
• Subjects voluntarily and strictly comply with the research protocol requirements and sign a written informed consent
• Subjects can independently fill out patient diaries.

Exclusion criteria

• Patients receiving moderate or high emetic radioation therapy within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
• Within 24 hours after chemotherapy, patients receiving any known or potential antiemetic agents and appearing symptoms vomiting, nausea, or mild nausea symptoms.
• Scheduled to receive inducer or substrate or strong / moderate inhibitor of cytocrome P450 3A4 (CYP3A4) within 3 weeks prior to day 1.
• Patients who cannot tolerate chemotherapy drugs.
• Serious cardiovascular, pulmonary disease, diabetes, mental and other diseases.
• Pregnant , breastfeeding and woman with child-bearing potential who are unwilling or unable to take effective contraceptive measures.
• Drug addict or alcohol abuse.
• Hypocalcemia or any other condition that may cause vomiting.
• Patients has significant factors that affect the absorption of oral medication, such as chronic diarrhea or obstruction.
• Subjects has hypersensitivity to netupitant/palonostron capsules or any of its excipients.
• Scheduled to receive any antiemetic agents within 3 weeks prior to day 1(including but not limited to: neurokin-1 (NK1) receptor antagonist, 5-HT3 receptor antagonists, olanzapine, scopolamine,et al.).
• Scheduled to receive benzodiazepine, opioid or opioid derivatives (except midazolam, temazepam or triazolam)within 1 week before chemotherapy or day 1 to 5 after chemotherapy.
• Subjects are currently enrolled in an other clinical study with any other clinical trials, investigational drugs or observational studies within 21 days of baseline.
• Investigators judged other situations that may affect the progress and results of clinical research.