Cervical cancer
Conditions
Interventions
Experimental Group:Concurrent chemoradiotherapy + intracavitary hyperthermia
Sponsors
Tianjin Cancer Hospital Airport Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years old; 2. Histologically diagnosed newly diagnosed cervical squamous cell carcinoma, clinical stage IB3-?A (FIGO 2018 staging); 3. At least 1 measurable lesion according to RECIST 1.1 standard; 4. No severe hematopoietic dysfunction, heart, lung, liver, kidney dysfunction and immunodeficiency, Laboratory test results meet the following criteria: Hemoglobin >= 90g/L; Absolute neutrophil count >= 2×10^9/L or white blood cell count >= 4.0×10^9/L; Platelet count >= 100×10^9/L; Aspartate aminotransferase (AST) = 3 months; 7. Women with potential fertility must have negative serum or urine HCG within 72 hours before enrollment (postmenopausal women must have amenorrhea for at least 12 months to be considered infertile. Women who have been confirmed to have undergone tubal ligation are not required to undergo pregnancy tests); 8. Those without intrauterine contraceptive devices; 9. Women with potential fertility are willing to take medically approved contraceptive measures during the trial; 10. Good compliance and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with cervical adenocarcinoma and malignant tumors of rare pathological types; 2. Patients who have received surgical treatment, pelvic radiotherapy, systemic chemotherapy,tumor targeted therapy, and immunotherapy for cervical cancer in the past; 3. Patients with bilateral ureteral obstruction who cannot undergo ureteral stent placement or pyelostomy; 4. Patients who are pregnant or breastfeeding; 5. Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or fistula risk; 6. Patients infected with human immunodeficiency virus (HIV); 7. Patients with active hepatitis B (HBV DNA quantitative test results exceed the lower limit of detection), or HCV infection (HCV RNA quantitative test results exceed the lower limit of detection); 8. Have a serious underlying medical condition that precludes safe administration of the trial treatment. Including but not limited to active infection requiring systemic medication: negligent compensated heart failure (NYHA grades III and IV), unstable angina, acute myocardial infarction within 3 months prior to enrollment; 9. Patients with a history of other malignant tumors (except cured basal cell carcinoma of the skin); 10. Patients with Crohn's disease and ulcerative colitis; 11. Patients participating in other clinical trials or those who have stopped clinical trials for less than 4 weeks; 12. Patients with known allergies to nimotuzumab or its components; 13. Patients with contraindications to cisplatin; 14. Patients with neurological or psychiatric disorders that affect cognitive ability; 15. Patients who cannot undergo intracavitary radiotherapy after evaluation of the lesions by the researchers; 16. Patients who are judged by the researchers to be unsuitable for participation in this study for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of radiation-induced vaginal stenosis of CTCAE 5.0 grade 3 or above; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival;Median progression-free survival;Overall Survival;Median overall survival;Disease Control Rate;Adverse event rate and quality of life; | — |
Countries
China
Contacts
Public ContactZhongjie Chen
Tianjin Cancer Hospital Airport Hospital
Outcome results
None listed