Last updated: October 22, 2023
Sponsor: Sichuan Cancer Hospital and Research Institute
Overall Status: Active - Not Recruiting
Phase
N/A
Condition
Vomiting
Lung Cancer
Carcinoma
Treatment
Netopitam Palonosetron capsules and dexamethasone
Clinical Study ID
NCT06102447
SCCHEC-02-2023-076
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female, aged 18-75 years old;
- Head and neck tumors confirmed by histology or cytology (including oral cancer,oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer);
- Receive radical synchronous radiotherapy and chemotherapy;
- The Eastern Oncology Collaborative Group (ECOG) physical fitness score of the subjectswas ≤ 2 points;
- Adequate organ and bone marrow function;
- The expected life is at least 12 weeks;
- Pregnant or fertile patients (male or female) use reliable contraceptive measures;
- When screening female patients with potential pregnancy, the pregnancy test must benegative;
- The subjects voluntarily and strictly comply with the requirements of the researchprotocol and sign a written informed consent form.
Exclusion
Exclusion Criteria:
- Recurrent and metastatic head and neck tumors;
- Previously underwent tumor resection surgery for treatment;
- Patients with platinum drug intolerance;
- Receiving any known or potential antiemetic medication within 24 hours prior to thefirst day, or experiencing symptoms of vomiting, retching, or mild nausea within 24hours prior to the first day;
- Take NK1(neurokinin-1) receptor antagonists or any study medication within 4 weeksbefore the start of the experiment;
- Use CYP3A4 inducer within 4 weeks before chemotherapy, and use CYP3A4 substrate orstrong or moderate CYP3A4 inhibitor within 1 week;
- Serious cardiovascular, pulmonary, diabetes, mental and other diseases;
- Pregnant or lactating women, patients with fertility who are unwilling or unable totake effective contraceptive measures;
- Drug and/or alcohol abuse;
- Hypocalcemia or any other condition that may cause vomiting;
- There are significant factors that affect the absorption of oral medication, such aschronic diarrhea and intestinal obstruction;
- The subject has allergic reactions to Netopitam Palonosetron capsules or any of theirexcipients;
- Within 30 days prior to the baseline visit, the subject participated in anotherclinical study and used any exploratory drugs or devices; Allow participation inobservational research;
- The researcher determines other situations that may affect the progress of clinicalresearch and the determination of research results.
Study Design
Total Participants: 36
Treatment Group(s): 1
Primary Treatment: Netopitam Palonosetron capsules and dexamethasone
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
January 01, 2026
Connect with a study center
Sichuan Cancer Hospital and Research Institute
Chengdu, Sichuan 610041
ChinaSite Not Available

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