Trials / Recruiting
RecruitingNCT05941741
IC Plus Low-dose Radiation Plus Cadonilimab in LANPC
Induction Chemotherapy Combined With Low-dose Radiation Plus Cadonilimab in Loco-regionally Advanced Nasopharyngeal Carcinoma: a Multi-center, Open-label, Randomized Controlled Phase III Clinical Trial
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 380 (estimated)
- Sponsor
- Sun Yat-sen University · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This is a multi-center, open-label, randomized controlled phase III clinical trial in primary diagnosed loco-regionally advanced nasopharyngeal carcinoma (NPC) patients. The purpose of this study is to evaluate the efficacy of induction chemotherapy (IC) combined with low-dose radiation and immune checkpoint inhibitor (ICI) followed by concurrent chemoradiotherapy (CCRT) versus IC+CCRT, and compare the treatment-related adverse events and quality of life in two groups.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| RADIATION | Intensity Modulated Radiation Therapy | All target volumes will be outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes are defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose is 70-72 Gy to PTVp (Planning target volume of the primary tumor), 64-70 Gy to PTVn (Planning target volume of the lymph node), 60- 64Gy to PTV1 (High-risk planning target volume), and 54-58 Gy to PTV2 (Low-risk planning target volume) in 30-32 fractions. |
| DRUG | Chemotherapy | Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles |
| BIOLOGICAL | Immune checkpoint inhibitor | Cadonilimab: 10mg/kg, Q3W, 3 cycles |
| RADIATION | Low-dose radiotherapy | Low-dose radiotherapy will be performed to study group, with the use of IMRT. |
Timeline
- Start date
- 2024-01-10
- Primary completion
- 2026-12-01
- Completion
- 2029-12-01
- First posted
- 2023-07-12
- Last updated
- 2026-03-18
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05941741. Inclusion in this directory is not an endorsement.