Last updated: February 2, 2023
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
2
Condition
Nasopharyngeal Cancer
Treatment
N/AClinical Study ID
NCT05724355
SYSUCC-CMY-2022-CDK46
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.
- ECOG performance status of 0 or 1.
- Progression after previous treatment with platinum-based dual-drug chemotherapy.
- Progression after previous treatment with PD-1 inhibitors.
- Experieced at least 1 line systemic therapy.
- Subjects enrolled must have measurable lesion(s) according to response evaluationcriteria in solid (RECIST) v1.1.
- Adequate organ function assessed by laboratory parameters during the screening period.
- Life expectancy more than 12 weeks.
- Able to understand and sign an informed consent form (ICF).
- Able to swallow the pill.
Exclusion
Exclusion Criteria:
- Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
- Previous treatment over 3 lines.
- Prior use of CDK4/6 inhibitors.
- Patients with other malignancies.
- Patients with known or suspected autoimmune diseases including dementia and seizures.
- Multiple factors affecting the absorption of oral medications (e.g., dysphagia,chronic diarrhea, and bowel obstruction).
- An excessive dose of glucocorticoids given within 4 weeks before enrollment.
- Complications requiring long-term use of immunosuppressive drugs or systemic or localuse of immunosuppressive-dose corticosteroids.
- Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or whohave received anti-TB treatment within 1 year prior to screening.
- HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibodypositive).
- Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment.
- Women of childbearing age with a positive pregnancy test and lactating women.
Study Design
Total Participants: 32
Study Start date:
September 01, 2022
Estimated Completion Date:
October 31, 2024
Connect with a study center
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
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