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Trial Title:
CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
NCT ID:
NCT05724355
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Nasopharyngeal Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Dalpiciclib Isetionate Tablets, Camrelizumab
Description:
Dalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.
Arm group label:
Dalpiciclib plus Camrelizumab
Summary:
Because most patients with R/M NPC have received long-term maintenance of immunotherapy
at the time of initial treatment and the first-line treatment, there are a large number
of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent
problem in clinical practice.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC.
2. ECOG performance status of 0 or 1.
3. Progression after previous treatment with platinum-based dual-drug chemotherapy.
4. Progression after previous treatment with PD-1 inhibitors.
5. Experieced at least 1 line systemic therapy.
6. Subjects enrolled must have measurable lesion(s) according to response evaluation
criteria in solid (RECIST) v1.1.
7. Adequate organ function assessed by laboratory parameters during the screening
period.
8. Life expectancy more than 12 weeks.
9. Able to understand and sign an informed consent form (ICF).
10. Able to swallow the pill.
Exclusion Criteria:
1. Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
2. Previous treatment over 3 lines.
3. Prior use of CDK4/6 inhibitors.
4. Patients with other malignancies.
5. Patients with known or suspected autoimmune diseases including dementia and
seizures.
6. Multiple factors affecting the absorption of oral medications (e.g., dysphagia,
chronic diarrhea, and bowel obstruction).
7. An excessive dose of glucocorticoids given within 4 weeks before enrollment.
8. Complications requiring long-term use of immunosuppressive drugs or systemic or
local use of immunosuppressive-dose corticosteroids.
9. Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who
have received anti-TB treatment within 1 year prior to screening.
10. HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative
detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV
antibody positive).
11. Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc.,
within 4 weeks before enrollment.
12. Women of childbearing age with a positive pregnancy test and lactating women.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming-Yuan Chen, MD,PhD
Phone:
86-20-8734-2422
Email:
chmingy@mail.sysu.edu.cn
Start date:
September 1, 2022
Completion date:
October 2024
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05724355
