Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT07249957
Eligibility Criteria:
Inclusion Criteria:
1. The patient voluntarily participated in this study and signed the informed consent form;
2. Age range: 50 to 75 years old;
3. Patients with cervical cancer who had not undergone surgery or chemotherapy and were initially diagnosed with squamous cell carcinoma by pathological histology, and were HPV high-risk positive;
4. According to the 2018 International Federation of Gynecology and Obstetrics (FIGO) staging system, it was stage IIb (tumor size \< 4 cm);
5. ECOG score: 0 to 1, with an expected survival of more than 6 months;
6. Pregnant women must undergo a pregnancy test (serum or urine) 7 days before enrollment, and the result must be negative, and they are willing to use appropriate contraceptive methods during the trial;
7. According to the investigator's judgment, there are no absolute contraindications to radiotherapy and chemotherapy or surgery, and they can comply with the trial protocol.
Exclusion Criteria:
1. Active or uncontrolled severe infections;
2. Cirrhosis, decompensated liver disease;
3. History of immunodeficiency, including HIV positive or having other acquired congenital immune deficiency diseases;
4. Chronic renal insufficiency and renal failure;
5. Patients with other malignancies that require treatment and/or newly diagnosed within 5 years;
6. Myocardial infarction, severe arrhythmia, and ≥ grade 2 congestive heart failure (NYHA classification);
7. Patients who have undergone pelvic artery embolization;
8. Patients who have received radiotherapy for pelvic malignant tumors in the past;
9. Patients who have received partial hysterectomy or radical hysterectomy in the past;
10. Patients with a history of severe allergic reaction to platinum-based chemotherapy drugs;
11. Comorbidities, requiring the use of drugs that cause significant liver and kidney damage during treatment, such as tuberculosis, etc.;
12. Patients who cannot understand the experimental content and cannot cooperate, or who refuse to sign the informed consent form;
13. Patients with serious accompanying diseases or other special conditions that seriously endanger their safety or affect their ability to complete the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT07249957
Study Brief:
Protocol Section:
NCT07249957