Nimotuzumab in Combined With Chemotherapy for Treatment of IVB Stage,Rrecurrent or Persistent Cervical Carcinoma

Korábbi kezelés

• Bone metastases alone or multiple metastases with bone metastases requiring radiotherapy for pain relief ;
• Patients with recurrence and metastasis after the end of the last administration of neoadjuvant chemotherapy or postoperative adjuvant chemotherapy < 6 months ;
• Major surgery within 4 weeks or planned surgery or radiation therap ;
• Participants in other interventional clinical trials within 1 month prior to informed consent ;
• Any other serious complications or dysfunction of the organ system, as judged by the investigator, will affect the safety of the patient or interfere with the evaluation of the test drug ; -

Más betegség

• Neurological or psychiatric abnormalities that affect cognitive ability, including brain metastases ;
• Active clinical infection (>grade 2 NCI-CTCAE 4.03), active tuberculosis, and known or self-reported HIV infection or active hepatitis B or C ;
• Severe respiratory system, blood system disease, intractable dysentery or intestinal cramps, intestinal obstruction, or poorly controlled diabetes ;
• Uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg), congestive heart failure above NYHA Ⅲ, unstable angina or poorly controlled arrhythmia , circulatory diseases such as myocardial infarction before enrollment within 6 months ;
• Have allergic reactions to study drugs and similar drugs ;
• Other malignant tumor;

Laborértékek

• Received anti-EGFR monoclonal antibody or small molecule TKI within 6 months prior to enrollment ;

Egyéb

• Simple mediastinal or/and supraclavicular lymph node metastases ;
• With clear peripheral neuropathy and related symptoms in the past;
• Pregnant or breast-feeding or refused to take contraceptive method;

• Voluntary and sign a consent form;
• Age 18-75 years old ;
• Histological diagnosis as cervical squamous cell carcinoma ;
• Histologically and/or cytologically confirmed stage IVB or first recurrent or persistent cervical cancer (Mainly refers to the primary radiotherapy or concurrent chemoradiotherapy at least 3 months after the tumor remains or progress) and patients cannot receive surgery or radiation ;
• Received taxoplatin + platinum combined chemotherapy stopped taking the drug for at least half a year, or received radiotherapy or concurrent chemoradiotherapy (cisplatin or cisplatin combined with 5-FU) for at least 3 months ;
• According to the RECIST 1.1 criteria,there is at least one measurable lesion . The maximum diameter must meet the requirements : CT scan ≥10mm (CT scan thickness is less than 5mm); Clinical routine examination instrument 10mm (tumor lesions that cannot be accurately measured by diameter instruments should be recorded as unmeasurable), chest X-ray ≥20mm; Malignant lymph nodes: pathologically enlarged and measurable, single lymph node CT scan diameter ≥15mm (CT scan Layer thickness not more than 5mm) ;
• Patients need to recover from toxic side effects (except decreased hemoglobin) of previous treatments (surgery, chemoradiotherapy, radiation therapy) to grade 1 or below （CTCAE 4.03）;
• ECOG performance status 0-1 ;
• Life expectancy of more than 3 months ;
• Haemoglobin≥90g/L,white blood cell(WBC)≥4×109/L,Absolute neutrophil count≥1.5×109/L,platelet count≥100×109/L ;
• TBIL≤1.5 ULN; ALK,AST and ALT≤2.5 ULN or ≤5 ULN(Liver metastasis) ; serum creatinine ≤ 1.5 ULN -