Locally advanced head and neck squamous cell carcinoma (including nasopharyngeal carcinoma)
Conditions
Interventions
experimental group:TPF induction chemotherapy regimen
Sponsors
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: ? Newly treated patients with locally advanced head and neck squamous cell carcinoma diagnosed by pathology who are not suitable for immediate surgery or radiotherapy as assessed by MDT, and locally advanced head and neck squamous cell carcinoma patients who need induction chemotherapy:stage III–IVA locally advanced nasopharyngeal carcinomastage III–IVA (except T3-4N0). ? Aged 18 to 70 years old. ? ECOG score = 50%. ? The liver, kidney, and bone marrow functions are roughly normal. a) ALT, AST = 60 ml/min. (According to the Cockcroft and Gault formula). c) WBC >= 4.0 x 10^9/L and ANC >= 2 x 10^9/L and PLT >= 100 x 10^9/L and Hb >= 90g/L without bleeding tendency. ? According to the RECIST1.1 solid tumor efficacy evaluation standard, the patient has at least one imaging (CT, PET-CT, MRI) measurable or evaluable lesion. ? Voluntarily join the group and sign an informed consent form, follow the experimental treatment plan and visit plan.
Exclusion criteria
Exclusion criteria: ? At the same time use other trial drugs or are in other clinical trials; ? Have a history of hypersensitivity to paclitaxel, cisplatin, raltitrexed or any excipients. ? Hematopoietic stem cell transplantation or bone marrow transplantation. ? Received PEG-rhG-CSF treatment before joining the group. ? Severe medical diseases such as severe heart, lung, liver or kidney dysfunction and infection; ? Patients with severe uncontrollable diabetes. ? Thrombotic or embolic venous or arterial events occurred within 6 months before enrollment, such as cerebrovascular accidents, including transient ischemic attack, arterial thrombosis, deep vein thrombosis, pulmonary embolism, etc.; had hemorrhage Sexual diseases or abnormal blood coagulation function; ? Interstitial lung disease, drug-induced interstitial lung disease, active interstitial lung disease with clinical evidence; ? Hepatitis B, hepatitis C or human immunodeficiency virus (HIV antibody positive). Past or cured HBV infections are only eligible to participate in this study when HBV DNA ?1000cps/ml. Patients with positive hepatitis C (HCV) antibodies are only eligible to participate in this study if the polymerase chain reaction shows negative HCV RNA. ? Combined with acquired immunodeficiency syndrome. ? In the 28 days before randomization, there are other major operations besides the biopsy or tracheotomy for the diagnosis of head and neck squamous cell carcinoma, or major surgery is expected to be performed during the study period; ? Within 4 weeks (28 days) before randomization Vaccination of any live vaccine (for example, vaccines against infectious diseases, such as flu vaccine, chickenpox vaccine, etc.); ? pregnant or breastfeeding female patients. ? Suspect or do have drug abusers, drug abusers, or alcohol abusers. ? Severe mental or nervous system disorders that affect informed consent and/or the expression or observation of adverse reactions. ? In the last five years, there is a history of other malignant tumors, except for cured skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;Overall survival;Safety index;Quality of life; | — |
Countries
China
Contacts
Public ContactGui Lin
National Cancer center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed