Nasopharyngeal Carcinoma (NPC)
Conditions
Keywords
Nasopharyngeal Carcinoma, EBV DNA, MRI, risk-adapted adjuvant therapy, Tislelizumab, capecitabine
Brief summary
This study aims to explore the efficacy and safety of risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI in nasopharyngeal carcinoma patients.
Detailed description
This study aims to evaluate whether the 2-year failure-free survival of NPC patients treated with GP induction chemotherapy, IMRT and risk-adapted adjuvant therapy based on dynamic EBV-DNA changes and MRI results at the end of radiotherapy, is superior to that of a historical control cohort receiving standard treatment.
Interventions
OTHERObservation
Clinical follow-up and surveillance only.
DRUGAdjuvant therapy
Capecitabine for medium-risk group Capecitabine: 1000 mg/m² orally twice daily on days 1-14，every 3 weeks. Treatment duration: 8 cycles
Sponsors
Fudan University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18 - 65 years old * Pathologically confirmed nasopharyngeal carcinoma, WHO type II or III non-keratinizing squamous cell carcinoma. * AJCC/UICC 9th edition stage II - III; excluding patients with T3N0M0 (only posterior pharyngeal lymph node metastasis) and T3N1M0. * Baseline plasma EBV-DNA \> 0, and able to complete dynamic monitoring according to the protocol. * ECOG 0 - 1. * Main organ functions meet the requirements: neutrophils ≥ 2.0×10\^9/L, platelets ≥ 100×10\^9/L, hemoglobin ≥ 90 g/L; ALT/AST ≤ 1.5×ULN, total bilirubin ≤ 1.5×ULN; creatinine clearance rate ≥ 60 mL/min. * Signed informed consent form, willing to complete the study according to the protocol.
Exclusion criteria
* Clinical or imaging examinations have confirmed distant metastasis. * Before the diagnosis of nasopharyngeal carcinoma, the patient had received chemotherapy, targeted therapy, or immunotherapy, and had a history of radiotherapy or surgery for head and neck tumors (except for diagnostic biopsies). * Has an active autoimmune disease, but the following conditions are excluded: type 1 diabetes, hypothyroidism receiving replacement therapy, and skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia). * Active hepatitis B with poor control of HBV DNA, active hepatitis C, HIV infection or uncontrolled infection. * Within 4 weeks before signing the informed consent form, the patient had used systemic glucocorticoids (equivalent to prednisone dose \> 10mg/day) or other immunosuppressive treatments; if the patient's systemic glucocorticoid dose is equivalent to prednisone ≤ 10mg/day or only uses inhaled or topical glucocorticoids, participation is allowed. * Has a history of active tuberculosis (Mycobacterium tuberculosis infection) in the past year; if active tuberculosis has been fully treated and has been over one year ago, participation is allowed. * Has a history of interstitial lung disease. * Has received live vaccines within 4 weeks before signing the informed consent form, or is about to receive live vaccines in the near future. * Pregnant or lactating women, or reproductive-aged subjects who do not agree to take effective contraceptive measures. * Has a history of other malignant tumors within the past 5 years, but the following situations are excluded: cured localized tumors, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, breast carcinoma in situ, papillary thyroid carcinoma, etc. * Cannot take oral medications or have a known severe allergy to capecitabine, tislelizumab, or cisplatin/gemcitabine. * Has any other conditions, including symptomatic heart failure, unstable angina pectoris, myocardial infarction, active infections requiring systemic treatment, mental illness or family/social factors, which the investigator believes may affect the patient's ability to sign the informed consent form, cooperate and participate in the study, or interfere with the interpretation of the study results.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year Failure Free Survival, 2-y FFS | 2 years | calculated from the date of diagnosis of NPC to the date of tumor recurrence, progression, distant metastasis or death due to any cause，whichever comes earlier. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overal Survival，OS | 2 years | calculated from the date of diagnosis of NPC to the date of death from any cause |
| Locoregionally Failure Free Survival，LRFFS | 2 years | calculated from the date of diagnosis of NPC to the date of locoregional failure or date of death from any cause, whichever comes earlier. |
| Distant failure free survival, DFFS | 2 years | calculated from the date of diagnosis of NPC to the date of distant metastasis or date of death from any cause, whichever comes earlier. |
| Adverse effects (AE) | during and after treatment （up to 2 years） | — |
| Objective Response Rate | at the end of, 3 months and 6 months after IMRT | — |
Countries
China
Contacts
CONTACTXiayun He, MD
CONTACTFen Xue, MD
PRINCIPAL_INVESTIGATORXiayun He
Fudan University
Outcome results
None listed