cervical cancer
Conditions
Interventions
Chinese medicine treatment group:Chinese medicine treatment group: After the start of radiotherapy, 10 mL of GDNPs are given daily, one dose each time, for a course of 3 months.
placebo control group:Placebo control group: 10 milliliters of placebo is administered daily after radiotherapy, 1 dose each time, for a duration of 3 months.
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Female
Age
60 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to any study-related procedures, patients fully understand the study and voluntarily sign a written informed consent form; 2. Aged 60-75 years; 3. Patients with pathologically confirmed cervical cancer (2018 FIGO staging) at stages IB3, II, III, or IVA; 4. Patients who have not received pelvic local radiotherapy or cervical cancer surgical treatment before enrollment and are willing to undergo radical cervical cancer radiotherapy and chemotherapy; 5. Patients in generally good condition with no obvious symptoms, with KPS > 70 points; RTOG Recursive Partitioning Analysis (RPA) index = 6 months; 7. Basic normal organ function (laboratory test results within the last 1 week before enrollment without continuous supportive treatment): neutrophils > 1.5 x 10^9/L, platelets > 100 x 10^9/L, hemoglobin > 9.0 g/dL; bilirubin normal or < 1.5 x ULN; AST (SGOT), ALT (SGPT) < 2.5 x ULN (if liver metastasis is present, < 5 x ULN); serum creatinine < 1.5 x ULN.
Exclusion criteria
Exclusion criteria: 1. Previously received pelvic radiotherapy; 2. Previously received cervical cancer related surgical treatment; 3. Poor general condition, KPS < 70 points; 4. RTOG recursive partitioning analysis (RPA) = 3; 5. Pregnant patients; 6. Patients with severe and uncontrolled organic diseases or infections, such as decompensated heart, lung, kidney function failure, which leads to intolerance to radiotherapy, targeted therapy or chemotherapy; 7. Second primary tumor; 8. Received major surgery within 4 weeks of randomization; 9. Allergic constitution, such as history of allergy to two or more drugs or foods, or known allergy to the components of the drug; 10. Other factors that the researchers deem inappropriate for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| biomolecule on surface;inflammation omics; | — |
Secondary
| Measure | Time frame |
|---|---|
| incidence of radiation therapy adverse reactions;local control rate at one year;Progression-Free Survival rate at one year; | — |
Countries
China
Contacts
Public ContactMa Chenying
The First Affiliated Hospital of Soochow University
Outcome results
None listed