cervical cancer
Conditions
Interventions
experimental group:Application of cadonilimab combined with concurrent chemoradiotherapy in adjuvant treatment after cervical cancer radical surgery
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1) Cervical cancer patients (who have undergone cervical cancer radical surgery within 8 weeks), FIGO 2018 IIIC1 + T>4cm,IIIC2, has not received any definitive radiotherapy or systematic treatment for cervical cancer in the past, and has not received immunotherapy, and has been evaluated by a radiation therapy physician as feasible for radiation therapy; 2) Cervical adenocarcinoma, cervical squamous cell carcinoma, or cervical adenosquamous carcinoma confirmed by previous histology; 3) Researchers evaluate suitability for receiving radiation therapy; 4) ECOG 0-2 points; 5) Age range from 18 to 65 years old; 6) No history of severe allergies; 7) Hemoglobin = 100 g/L, WBC = 3.5 * 109/L, neutrophils = 1.5 * 10^9, platelets = 100 * 10^9/L; CR1.5 Normal upper limit, TB2.5 normal upper limit, AST and ALT 2.5 normal upper limit, AKP2.5 normal upper limit; 8) Good renal function; 9) Able to sign informed consent form.
Exclusion criteria
Exclusion criteria: 1) Received chemotherapy, radiation therapy, immunotherapy, or other anti-tumor treatments; 2) Histologically diagnosed as other pathological types such as small cell (neuroendocrine) cervical cancer, mucinous adenocarcinoma, or carcinosarcoma; 3) There is distant metastasis 4) Hydronephrosis in both kidneys, inability to place ureteral stent or inability to perform nephrostomy; 5) There are contraindications to platinum based chemotherapy; 6) Suffering from other malignant tumors; 7) Pregnant women or lactating patients; 8) There has been a history of thyroid dysfunction, and even with medication treatment, thyroid function cannot be maintained within the normal range; 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 and requiring systemic treatment within the past 2 years; 11) A history of (non infectious) pneumonia requiring steroids or current pneumonia; 12) Active infections that require systematic treatment; 13) Has a known history of human immunodeficiency virus (HIV) infection; 14) Having a known history of hepatitis B or known 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) 14 days prior to enrollment, underwent major surgical treatment and has not yet recovered; 18) Participate in other clinical trials currently or within 28 days prior to being selected; 19) Exposure to immune mediated therapy for any indication prior to the study, 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, research drugs, biological products, or hormone therapy used to treat tumors. Hormone therapy can be used simultaneously to treat non tumor related diseases (such as hormone replacement therapy); 21) Allogeneic tissue/solid organ transplantation was performed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;Safety; | — |
Countries
China
Contacts
Public ContactKe Guihao
Fudan University Shanghai Cancer Center
Outcome results
None listed