Cervical cancer
Conditions
Interventions
Experimental group:Nimotuzumab combined with concurrent chemoradiotherapy
Sponsors
The First Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. ECOG score 0-1; 3. Confirmed by histology/cytology of cervical squamous cell carcinoma, adenosquamous cell carcinoma, FIGO 2018 stage IB3, stage II.A2, stage IIB (tumor diameter>=4cm), stage III--IVA; 4. Estimated survival >=6 months; 5. At least one measurable lesion according to RECIST version 1.1 evaluation criteria; 6. The functional level of major organs must meet the following requirements: Complete blood count: ANC>=1.0×10^9/L; PLT>=75×10^9/L; Hb>=80 g/L; Blood biochemistry: TBIL = 60 mL/min; 7. Females of potential childbearing potential with a negative blood ß-HCG or urine pregnancy test within 72 hours prior to dosing (postmenopausal women with amenorrhea for at least 12 months are considered to be of non-childbearing potential, and women who are known to have undergone tubal ligation, pregnancy tests are not required); 8. For female subjects who are not postmenopausal or surgically sterilized, agree to abstinence or use an effective method of contraception during the treatment period and for at least 3 months after the last dose in the study treatment; 9. Voluntarily join this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.
Exclusion criteria
Exclusion criteria: 1.Cervical cancer excluding other pathological types such as squamous cell carcinoma of the cervix and adenosquamous carcinoma; 2. Previously received surgical treatment for cervical cancer, pelvic radiotherapy, systemic chemotherapy, targeted tumor therapy, and immunotherapy; 3. Those with bilateral ureteral obstruction who cannot have ureteral stents implanted or undergo pyelostomy; 4. Pregnant women or those who are breastfeeding; 5. Those with combined rectovaginal fistula/vaginal bladder fistula/uncontrolled massive vaginal hemorrhage or at risk of fistula; 6. People infected with human immunodeficiency Virus (HIV); 7. Active hepatitis B (HBV DNA quantitative test result exceeds the lower detection limit), or HCV infection (HCV RNA quantitative test result exceeds the lower detection limit); 8. Suffering from serious underlying diseases that make it impossible to safely administer the trial treatment. Including but not limited to active infections requiring systemic medication treatment: negligent compensatory heart failure (NYHA grades III and IV), unstable angina pectoris, and acute myocardial infarction occurred within 3 months before enrollment; 9. Those with a history of other malignant tumors (except for cured basal cell carcinoma of the skin); 10. People with Crohn's disease and ulcerative colitis; 11. Those who are currently participating in other clinical trials or have ceased clinical trials for less than 4 weeks; 12. Those known to be allergic to nimotuzumab or its components; 13. Those with contraindications for cisplatin use; 14. Those with neurological or mental abnormalities that affect cognitive abilities; 15. Those whose lesions, after assessment by the researcher, cannot undergo endovascular radiotherapy; 16. Other reasons that are not suitable for participation in this study as determined by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year progression-free survival rate (PFS);Safety: Evaluated in accordance with the CTCAE 5.0 standard; | — |
Secondary
| Measure | Time frame |
|---|---|
| 5-year progression-free survival rate (PFS);Tumor regression rate (TRR) before concurrent chemoradiotherapy;Objective response rate (ORR) 3 months after radiotherapy;5-year overall survival rate (OS);3-year overall survival rate (OS); | — |
Countries
China
Contacts
Public ContactJuan Wang
The First Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed