Nasopharyngeal Carcinoma, Immune Checkpoint Inhibitor, Radiotherapy, Chemotherapy
Conditions
Brief 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.
Interventions
RADIATIONIntensity 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.
DRUGChemotherapy
Induction chemotherapy: gemcitabine and cisplatin, Q3W, 3 cycles Concurrent chemotherapy: cisplatin, Q3W, 2-3 cycles
BIOLOGICALImmune checkpoint inhibitor
Cadonilimab: 10mg/kg, Q3W, 3 cycles
RADIATIONLow-dose radiotherapy
Low-dose radiotherapy will be performed to study group, with the use of IMRT.
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III); * All genders, range from 18-70 years old; * ECOG score 0-1; * Clinical stage T4N1M0 and T1-4N2-3M0 (AJCC/UICC 8th); * Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy); * No contraindications to chemotherapy, radiotherapy or immunotherapy; * Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 9g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula); * Sign the consent form.
Exclusion criteria
* Distant metastases; * Keratinized squamous cell carcinoma or basal cell like squamous cell carcinoma; * Have or are suffering from other malignant tumors; * Participating in other clinical trials; * Pregnancy or lactation; * Have uncontrolled cardiovascular disease; * Severe complication, eg, uncontrolled hypertension; * Mental disorder; * Drug or alcohol addition; * Do not have full capacity for civil acts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 3 years | From the date of randomization to local or regional recurrence, distant metastasis or any death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 3 years | From the date of randomization to any death, with patients unavailable for follow-up censored at the date of last follow-up |
| Local recurrence-free survival | 3 years | From the date of randomization to local recurrence or any death |
| Regional recurrence-free survival | 3 years | From the date of randomization to regional recurrence or any death |
| Distant metastasis-free survival | 3 years | From the date of randomization to distant metastasis or any death |
| Acute toxicities | From the start of treatment until 3 months post treatment | Assessed with CTCAE v5.0 |
| Late toxicities | 3 years post treatment | Assessed with RTOG/EORTC |
| Quality of life score | Through study completion, an average of 3 years | Assessed with EORTC-Quality of life questionnaire-C30 version 3.0 |
Countries
China
Contacts
CONTACTChong Zhao, MD, PhD
CONTACTJingjing Miao, MD
PRINCIPAL_INVESTIGATORChong Zhao, MD, PhD
Sun Yat-Sen University Cancer Center
Outcome results
None listed