Phase
Condition
Carcinoma
Lung Cancer
Squamous Cell Carcinoma
Treatment
Nimotuzumab
Paclitaxel
Placebo
Clinical Study ID
Ages 18-75 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 orpersistent cervical cancer (Mainly refers to the primary radiotherapy or concurrentchemoradiotherapy at least 3 months after the tumor remains or progress) andpatients cannot receive surgery or radiation ;
Received taxoplatin + platinum combined chemotherapy stopped taking the drug for atleast 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 . Themaximum diameter must meet the requirements : CT scan ≥10mm (CT scan thickness isless than 5mm); Clinical routine examination instrument 10mm (tumor lesions thatcannot be accurately measured by diameter instruments should be recorded asunmeasurable), chest X-ray ≥20mm; Malignant lymph nodes: pathologically enlarged andmeasurable, single lymph node CT scan diameter ≥15mm (CT scan Layer thickness notmore than 5mm) ;
Patients need to recover from toxic side effects (except decreased hemoglobin) ofprevious treatments (surgery, chemoradiotherapy, radiation therapy) to grade 1 orbelow (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 neutrophilcount≥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 -
Exclusion
Exclusion Criteria:
Simple mediastinal or/and supraclavicular lymph node metastases ;
Bone metastases alone or multiple metastases with bone metastases requiringradiotherapy for pain relief ;
Patients with recurrence and metastasis after the end of the last administration ofneoadjuvant chemotherapy or postoperative adjuvant chemotherapy < 6 months ;
Received anti-EGFR monoclonal antibody or small molecule TKI within 6 months priorto enrollment ;
Major surgery within 4 weeks or planned surgery or radiation therap ;
Participants in other interventional clinical trials within 1 month prior toinformed consent ;
Neurological or psychiatric abnormalities that affect cognitive ability, includingbrain metastases ;
With clear peripheral neuropathy and related symptoms in the past;
Active clinical infection (>grade 2 NCI-CTCAE 4.03), active tuberculosis, and knownor self-reported HIV infection or active hepatitis B or C ;
Severe respiratory system, blood system disease, intractable dysentery or intestinalcramps, intestinal obstruction, or poorly controlled diabetes ;
Uncontrolled hypertension (SBP>160mmHg or DBP>100mmHg), congestive heart failureabove NYHA Ⅲ, unstable angina or poorly controlled arrhythmia , circulatory diseasessuch as myocardial infarction before enrollment within 6 months ;
Have allergic reactions to study drugs and similar drugs ;
Pregnant or breast-feeding or refused to take contraceptive method;
Other malignant tumor;
Any other serious complications or dysfunction of the organ system, as judged by theinvestigator, will affect the safety of the patient or interfere with the evaluationof the test drug ; -
Study Design
Study Description
Connect with a study center
Cancer Institute and Hospital , Chinese Academy of Medical Sciences
Beijing,
ChinaSite Not Available

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