Cervical squamous cell carcinoma
Conditions
Sponsors
Baotou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18-75 years; 2.Patients with newly treated cervical squamous cell carcinoma diagnosed histologically with stage IB3, IIA, IIB, III, and IV A (FIGO 2018 stage); 3.According to RECIST 1.1, there was at least one measurable lesion; 4.There were no severe hemopoietic dysfunction, heart, lung, liver, kidney dysfunction and immune deficiency, the laboratory results meet the following criteria: Hemoglobin >= 90g / L; Absolute neutrophil count >= 2 x 10^9 / L or leukocyte count >= 4.0 x 1; 5.ECOG score was 0-2; 6.The expected survival time was more than 3 months; 7.Women with potential fertility were negative for HCG in serum or urine within 72 hours before enrollment (postmenopausal women must be amenorrhea for at least 12 months in order to be considered infertile). Pregnancy tests are not required for women who have been confirmed to have undergone tubal ligation.); 8.Without intrauterine device; 9.Women with potential fertility are willing to take the contraceptive measures approved by the doctors in the trial; 10.Good compliance, willing to sign informed consent.
Exclusion criteria
Exclusion criteria: 1.Cervical adenocarcinoma and rare pathological type of malignant tumor; 2.Recurrent cervical cancer or distant organ metastasis; 3.Previous hysterectomy, pelvic radiotherapy, systemic chemotherapy, tumor targeted therapy and immunotherapy; 4.Bilateral ureteral obstruction, unable to place ureteral stent or perform pyelostomy; 5.Pregnant or lactating patients; 6.Complicated with rectovaginal fistula, vaginal bladder fistula, uncontrolled vaginal bleeding; 7.Human immunodeficiency virus (HIV) infection; 8.Known active hepatitis B (serum HBV DNA detected by PCR is higher than the lower limit of detection), or known hepatitis C (HCV quantitative RNA results exceed the lower limit of detection); 9.Suffering from serious underlying diseases, which makes it impossible to give trial treatment safely. Including but not limited to severe active infection, negligent compensatory heart failure (NYHA grade III and IV), unstable angina pectoris and acute myocardial infarction within 3 months before enrollment; 10.Patients with a history of other malignancies (except for basal cell carcinoma of the skin that has received potentially curative treatment); 11.Patients with Crohn's disease and ulcerative colitis; 12.Participate in the experimental treatment of other clinical studies at the same time; 13.Known allergy to nimotuzumab and cisplatin; 14.The patient has mental illness that interferes with the participation or completion of the study, or has no or limited capacity for civil conduct; 15.After the evaluation of the lesion by the researcher, the intracavitary radiotherapy cannot be performed; 16.According to the judgment of the researcher, there are other reasons not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2 year progression-free survival (PFS) rate;Objective response rate (ORR);complete response rate (CRR);Disease control rate (DCR);2-year overall survival (OS) rate;Local control rate for 2 years;Median totale survival (OS);Medina progression-free survival (PFS); | — |
Countries
China
Contacts
Public ContactWu Yun, Bai Xuelian
Baotou Central Hospital
Outcome results
None listed