Cervical cancer
Conditions
Interventions
1:Maintenance therapy of oligometastatic cervical cancer with combination of radiotherapy and chemotherapy plus Cadonilimab with or without bevacizumab
Sponsors
The 10th Hospital of Southern Medical University (Dongguan People's Hospital)
Eligibility
Sex/Gender
Female
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1 Age at diagnosis: 18–75 years old. 2 Histologically confirmed cervical cancer (adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma) by biopsy. 3 Diagnosis of advanced cervical cancer (TXNXM1) according to the 9th edition of the American Joint Committee on Cancer/Union for International Cancer Control (AJCC/UICC) and the 2018 FIGO clinical staging system (Appendix I). 4 ECOG performance status: 0–1. 5 Presence of 1–5 metastatic lesions involving no more than 3 metastatic organs at initial diagnosis, with metastatic lesions that can be treated with local radiotherapy or other therapies as assessed by a multidisciplinary team. 6 Normal bone marrow function: White blood cell count > 4×10^9/L, hemoglobin concentration > 90 g/L, platelet count > 100×10^9/L. 7 Normal liver and kidney function: Total bilirubin = 30 mL/min. 8 Normal thyroid function, amylase, lipase, pituitary function, inflammatory/infection markers, myocardial enzymes, and electrocardiogram (ECG) results. For patients over 50 years old with a smoking history, normal pulmonary function test results are required. For patients with abnormal ECG or a history of cardiovascular disease (that does not meet the exclusion criteria listed in item 7), additional myocardial function tests and echocardiography are required, with normal results. 9 Patients must sign an informed consent form and be willing and able to comply with the study schedule, including follow-up visits, treatments, laboratory tests, and other study requirements. 10 Women of childbearing potential must agree to use reliable contraception (e.g., condoms, oral contraceptives used as prescribed by a physician) from screening until 1 year after treatment.
Exclusion criteria
Exclusion criteria: 1 Hepatitis B surface antigen is positive and hepatitis B B virus quantification is>1 × 103 copies/ml, or anti hepatitis C virus antibody is positive; 2 Anti HIV antibody positive or diagnosed as acquired immunodeficiency syndrome (AIDS); 3 Active pulmonary tuberculosis: patients with active tuberculosis history in the past 1 year should be excluded regardless of treatment; Except for patients who have been confirmed to receive regular anti tuberculosis treatment in the past, patients with active tuberculosis history of more than one year should be excluded; 4 Active, known or suspected autoimmune diseases (including but not limited to uveitis, enteritis, hepatitis, pituitary diseases, nephritis, vasculitis, hyperthyroidism, hypothyroidism, and asthma requiring bronchodilation). Except for type 1 diabetes, hypothyroidism requiring hormone replacement therapy and skin diseases not requiring systemic treatment (such as vitiligo, psoriasis or alopecia); 5 Suffering from interstitial lung disease or pneumonia within the past year requiring oral or intravenous steroid treatment; 6 Chronic systemic corticosteroid (dose equal to or exceeding 10 mg prednisone per day) or any other form of immunosuppressive therapy. Subjects who inhale or apply corticosteroids topically are eligible; 7 Uncontrolled heart disease, such as: 1) heart failure, NYHA levels >= 2; 2) Unstable angina pectoris; 3) History of myocardial infarction in the past year; 4) Supraventricular arrhythmias or ventricular arrhythmias that require treatment or intervention; 8 Pregnant or lactating women (pregnancy tests should be considered for sexually active women of childbearing age); 9 Except for fully treated non melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma, those who have previously or currently suffered from other malignant tumors; 10 Allergic to any component of large molecule protein preparations or carbapenemab, albumin paclitaxel, carboplatin, or cisplatin; 11 Active infections that require systemic treatment within one week; 12 Receive live vaccine within 30 days prior to the first dose of Cardolizumab; 13 History of organ transplantation; 14 Other situations assessed by researchers that may endanger patient safety or compliance, such as serious illnesses (including mental illnesses) that require timely treatment, severe abnormal test results, and other psychological, family, or social high-risk factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression-free survival;safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival;Duration of Response; | — |
Countries
China
Contacts
Public ContactXuefang Zhang
the 10th Hospital of Southern Medical University (Dongguan People's Hospital)
Outcome results
None listed