CDK4/6 Inhibitor Plus Camrelizumab for PD-1 Inhibitor Refractory R/M NPC
- Sponsor
- Sun Yat-sen University
- Study ID
- NCT05724355
- Phase
- PHASE2
- Status
- Unknown
Conditions
- Nasopharyngeal Carcinoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Dalpiciclib Isetionate Tablets, Camrelizumab — DRUGDalpiciclib, D1-21, po, 150mg, qd, Q4W. Camrelizumab, iv, 200mg, D1, Q3W.
Study Details
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.
Key Dates
- Start date
- Sep 1, 2022
- Status verified
- Feb 2023
- Primary completion
- Oct 31, 2023
- Completion
- Oct 31, 2024
Study Design
- Enrollment
- 32 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Dalpiciclib plus Camrelizumab
Primary Outcome Measure
Objective response rate (ORR) [ Time Frame: 1 year ]
Central Contacts
- Ming-Yuan Chen, MD, PhD86-20-8734-3361
- Rui You, PhD86-13580439820
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