Nasopharyngeal carcinoma
Conditions
Interventions
Experimental group:The first stage is neoadjuvant chemotherapy, with one cycle every 3 weeks for a total of 3 cycles. The specific treatment plan is as follows: capecitabine, 1000 mg/?, oral, days 1-1
carboplatin, AUC=5, Q3W.
The second stage is the curative treatment stage, which includes routine radiotherapy for the primary lesion and cervical lymph node lesion, combined with nituzumab, 200 mg, Q
control group:Routine radiotherapy for the primary lesion and cervical lymph node lesion, combined with concurrent carboplatin, AUC=5, Q3W, 3 cycles
Sympathic treatment group:Choose one of the following options: 1) Simple curative radiotherapy, including routine radiotherapy for the primary lesion and cervical lymph node lesions
2) Radical radiotherapy combined with targeted therapy, specifically including routine radiotherapy for the primary and cervical lymph node lesions, synchronized with nituzumab, 200 mg, QW, 7-8 weeks
3) Radical radiotherapy combined with oral chemotherapy, with oral chemotherapy drugs chosen by the researchers themselves.
Sponsors
Dongguan People's Hospital
Eligibility
Sex/Gender
All
Age
70 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Gender unlimited, age = 70 years old; 2.Non keratinizing carcinoma of the nasopharynx (WHO type II or III) confirmed by pathological examination; 3.Clinical staging is stage III-IVa (AJCC/UICC 8th edition), with no evidence of distant metastasis; 4.ECOG score 0-1 points; 5.The patient has not received any anti-tumor treatments such as radiotherapy, chemotherapy, immunotherapy, or biological therapy for nasopharyngeal carcinoma in the past; 6.No contraindications for radiotherapy; 7.The main organ functions meet the following standards (no blood components or cell growth factors are allowed to be used within 14 days): a. The blood routine examination standards must meet: WBC = 4.0 × 109/L, ANC = 1.5 × 109/L, PLT = 80 × 109/L, HGB = 90g/L (no blood transfusion or blood products within 14 days, no correction with G-CSF or other hematopoietic stimulating factors); b. Total bilirubin = 1.5 × ULN; c. Patients without liver metastasis: alanine aminotransferase ALT and aspartate aminotransferase AST = 2.5 × ULN; d. Serum creatinine = 1.5 × ULN, or creatinine clearance rate = 50 mL/min (calculated according to Cockcroft Gault formula); (8) Expected lifespan = 12 weeks; (9) No bad habits such as drug use; (10) The subjects voluntarily joined this study, signed an informed consent form, voluntarily complied well, and cooperated with follow-up.
Exclusion criteria
Exclusion criteria: (1) The pathological type is keratinizing squamous cell carcinoma or basal cell like squamous cell carcinoma; (2) A history of other malignant tumors within the past 5 years or at the same time, except for cured skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, superficial bladder tumors (Ta, Ti, and T1), thyroid papillary carcinoma, and other cancers treated more than 3 years prior to the start of the study; (3) Participating in other clinical trials; (4) Individuals without or with limited capacity for civil conduct; (5) According to the researcher's judgment, there are other family or social factors that may cause the subject to be forced to terminate the study midway, which may affect the subject's safety or the collection of trial data, such as mental illness (including recent or active suicidal ideation or behavior) or abnormal laboratory tests. (6) Allergy to any component or other EGFR monoclonal antibodies in EGFR monoclonal antibody preparations, or intolerance or allergy to carboplatin injection, or intolerance or allergy to capecitabine; Or any diseases or external factors that may affect oral medication; (7) Have received anti-tumor vaccines or live vaccines within 4 weeks before the first administration of research drugs; (8) Has undergone major surgery or severe trauma within 4 weeks prior to the first use of the investigational drug; (9) Known history of abuse, alcoholism, and drug use of psychotropic substances; (10) Other situations that may affect the safety or compliance of the subjects, as determined by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| two-year Disease-free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Regional recurrence free survival rate;Survival rate without distant metastasis;Adverse events; | — |
Countries
China
Contacts
Public ContactZhigang Liu
Dongguan People's Hospital
Outcome results
None listed