Phase
Condition
Carcinoma
Squamous Cell Carcinoma
Lung Cancer
Treatment
N/AClinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥ 18 and ≤ 70 years of age.
Pathologically confirmed advanced head and neck squamous cell carcinoma, withmeasurable lesions (tumor lesions CT scan diameter ≥ 10mm, lymph node lesions CT scanshort diameter ≥ 15mm, the scan layer thickness is not greater than 5mm, measurableafter the lesion recurrence / metastasis Received radiotherapy, frozen and other localtreatment).
Patients with recurrent or metastatic head and neck squamous cell carcinoma who haveundergone radiotherapy and chemotherapy to treat disease progression. Note: adjuvant therapy within 6 months of recurrence, adjuvant therapy is defined asfirst-line treatment.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 2.
Life expectancy of more than 6 months.
Subjects underwent additional treatment of the damage recovered (NCI-CTCAE Version 4.0Grading ≤ 1), where the interval between receiving nitrosourea or mitomycin was> 6weeks; receiving other cytotoxic drugs, bevacizumab (Avastin), radiotherapy or surgery ≥ 4 weeks; EGFR TKI class of targeted drugs ≥ 2 weeks.
Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 80×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST
≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr ≤ 1.5×ULN, Crclearance ≥ 45 mL/min.
Women of childbearing age must have had reliable contraception or have had a pregnancytest (serum or urine) within 7 days prior to enrollment with a negative result andwould be prepared to use the appropriate method of contraception 8 weeks after thetest and the last administration of the test drug. For males, consent is to be givento contraception or surgical sterilization 8 weeks after the test and the lastadministration of the test drug.
Signed the informed consent form prior to patient entry.
Exclusion
Exclusion Criteria:
Non-squamous cell carcinoma (including squamous cell carcinoma mixed with otherpathological types), nasopharyngeal carcinoma.
Active brain metastases, meningococcal meningitis, patients with spinal cordcompression, or imaging at CT or MRI examination revealed brain or pia materdisease(Patients who have completed treatment and whose symptoms are stable in thefirst 21 days of randomization may be enrolled in the study but may be diagnosed ashaving no intracerebral hemorrhage by MRI, CT or venography).
Uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP
≥90 mmHg, despite optimal medical therapy).
grade II The above myocardial ischemia or myocardial infarction, poor control ofarrhythmia (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA standards, Ⅲ ~ Ⅳ grade cardiac insufficiency, or cardiac ultrasound examination prompted leftventricular ejection Score (LVEF) <50%.
Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies thatthe 24-h urine protein quantitation ≥ 1.0 g.
Patients who had obvious hemoptysis within 2 months before screening, or experienceddaily hemoptysis with a volume more than half a tea spoon (2.5ml) or above.
Coagulation dysfunction (INR> 1.5, PT> ULN +4s or APTT> 1.5 ULN), with bleedingtendency or ongoing thrombolysis or anti-blood coagulation treatment;Patients treatedwith anticoagulants or vitamin K antagonists such as warfarin, heparin, or the like.
Long-term, unhealed wounds or fractures.
Patients who have history of psychotropic substance abuse who can not be abstinent orwho have mental disorders.
According to the researchers' judgment, there are other serious patients who areendangered or have concomitant diseases that affect the completion of the study.
Patients with CNS metastases.
Pregnant or lactating women.
Researchers think it is not suitable for inclusion.
Study Design
Study Description
Connect with a study center
Henan Cancer Hospital
Zhengzhou, Henan 450008
ChinaActive - Recruiting

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