Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal carcinoma, PD-1 inhibitor, Anti-EGFR monoclonal antibody, Induced chemotherapy resistance
Brief summary
Because nasopharyngeal carcinoma （NPC）is very sensitive to radiation and the specificity of the anatomical structure, radiotherapy has become the core treatment for NPC. Although induction chemotherapy combined with cisplatin-based concurrent chemoradiotherapy can effectively improve the overall survival and progression-free survival of NPC, such a sequential pattern can further exacerbate the toxic side effects of treatment, such as mucosal reactions and gastrointestinal toxicity. Therefore, it is particularly important to explore another treatment mode with high efficiency and low toxicity. Secondly, patients with poor response after induction chemotherapy indicate chemotherapy resistance. Whether patients can still benefit from concurrent platinum-based chemotherapy in the followed radiotherapy is doubtful. PD-1 inhibitor and anti-EGFR monoclonal antibody have proved to improve outcomes of head and neck cancers including EBV-related NPC, which have also showed relatively low toxicity. In this study, radiotherapy combined with PD-1 inhibitor and anti-EGFR monoclonal antibody were applied to treat patients with locally advanced NPC who were resistant to induction chemotherapy.
Interventions
COMBINATION_PRODUCTAnti-EGFR and PD-1 inhibitor arm
Drug: PD-1 inhibitor and anti-EGFR monoclonal antibody The patients will receive radiotherapy (66-70.4Gy) combined with PD-1 inhibitor (every 3 weeks) and anti-EGFR monoclonal antibody (every 1 week). The specific treatment description is included in arm description.
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Histologically confirmed locally advanced NPC; IHC EGFR positive; Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; Imaging assessment of MR after induction chemotherapy revealed the responses to induction chemotherapy are less than 50% Partial Response(PR) or EBVDNA copy number decreased by less than 50%; No prior anti-tumor treatment; Normal complete blood count; Normal hepatic function; Normal renal function (creatinine ≤ 1.5 times the upper limit of normal). -
Exclusion criteria
Previous radiotherapy; A history of any other type of malignancy; Pregnancy or lactation; Allergy to anti-EGFR monoclonal antibody; IHC EGFR negative; Allergy to PD-1 inhibitor; Obvious disfunction of liver, renal, cardiac or lung function; Un controlled infection; Systemic metastasis or distant metastasis; Patients with severe gastrointestinal diseases; Patients with mental disorders affecting patient participation in trial judgement; Cannot take contrast-MRI imaging. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 3 years | Progression Free Survival |
| OS | 3 years | Overall Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DCR | 3 years | Disease-free survival |
| Number and percentage of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 and RTOG | 3 years | The detail number and percentage of adverse events by every systems Assessed by CTCAE v5.0 and RTOG. |
Countries
China
Contacts
Primary ContactXiaoshen Wang, MD, Ph.D
Backup ContactRuichen Li, MD
Outcome results
None listed