Cervical cancer
Conditions
Interventions
Trial Group:Standard radiochemotherapy plus concurrent tumor bed boost followed by sequential paclitaxel and platinum-based chemotherapy (6 cycles)
Control Group:Standard radiochemotherapy followed by sequential paclitaxel and platinum-based chemotherapy (6 cycles)
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with cervical cancer (who have undergone radical cervical cancer surgery within 8 weeks, FIGO 2018IA1-IIIC2, have medium to high-risk factors, require postoperative adjuvant chemoradiotherapy, and have tumor invasion depth of the deep muscular layer or above), have not received any definitive radiotherapy or systemic treatment for cervical cancer in the past, and have not received immunotherapy And it has been evaluated by the radiotherapy physician as feasible for radiotherapy; 2. Previously histologically confirmed cervical gastric adenocarcinoma; 3. The researcher assesses the suitability for radiotherapy; 4. ECOG 0-1 point; 5. Age: 18-65 years old; 6. No history of severe allergies; 7. Hemoglobin >=100 g/L, WBC>=3.5*10^9 /L, neutrophils >=1.5*10^9, platelets >=100*10^9 /L; CR<=1.5 × normal upper limit, TB<=2.5 × normal upper limit, AST and ALT<=2.5 × normal upper limit, AKP<=2.5× normal upper limit; 8. Good renal function; 9. Be able to sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Having received chemotherapy, radiation therapy, immunotherapy, or other anti-tumor treatments. 2. Histologically diagnosed as squamous cell carcinoma, small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma or carcinosarcoma, and other pathological types. 3. There is distant metastasis. 4. Bilateral hydronephrosis, unable to insert ureteral stent or undergo nephrostomy. 5. There are contraindications to platinum based chemotherapy. 6. Suffering from other malignant tumors. 7. Pregnant or lactating patients. 8. Previous thyroid dysfunction and inability to maintain normal thyroid function despite medication treatment. 9. Diagnosed with immunodeficiency or receiving chronic systemic steroid therapy (daily dose exceeding 10 mg of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to enrollment. 10. Suffering from active autoimmune disease, requiring systemic treatment within the past 2 years. 11. History of non infectious pneumonia requiring steroids or current pneumonia. 12. Active infections that require systematic treatment. 13. Known history of human immunodeficiency virus (HIV) infection. 14. Have a known history of hepatitis B or active hepatitis C virus infection. 15. Have a known history of active tuberculosis (TB; tubercle bacillus). 16. Uncontrolled concomitant diseases, including but not limited to: persistent or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled hypertension, uncontrolled diabetes, uncontrolled arrhythmia, active interstitial lung disease (ILD), severe chronic gastrointestinal diseases with diarrhea, or psychiatric/social problems that may restrict compliance with the study requirements, significantly increase AE risk or affect the ability of subjects to provide written informed consent. 17. Underwent major surgical treatment 14 days prior to enrollment and has not yet recovered. 18. Participate in other clinical trials within 28 days prior to being selected or currently enrolled. 19. Exposure to immune-mediated therapies for any indication prior to research, including but not limited to other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies or therapeutic anti-cancer vaccines. 20. Any synchronous chemotherapy, investigational drugs, biologics, or hormone therapy used to treat tumors. Hormone therapy can be used simultaneously to treat non tumor related conditions (such as hormone replacement therapy). 21. Conducted allogeneic tissue/solid organ transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-year Progression-Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Overall Survival; | — |
Countries
China
Contacts
Public ContactKe Guihao
Fudan University Shanghai Cancer Center
Outcome results
None listed