Cervical cancer
Conditions
Interventions
Experimental group:Induction Chemotherapy Combined with Immunotherapy
Sponsors
The Second People's Hospital of Yibin
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent form in writing. 2. Age greater than 18 years (at the time of signing the informed consent form for the study). 3. Patients with locally advanced cervical cancer confirmed by pathology or histology (FIGO 2018 stage IB3-IVA with a maximum tumor diameter of >=5cm). 4. Subjects must have measurable disease by CT or MRI according to RECIST 1.1 criteria. 5. No radiotherapy, chemotherapy, immunotherapy or biological therapy. 6. No contraindications to immunotherapy, radiotherapy, chemotherapy. 7. Karnofsky scale (KPS) >=70. 8. Hemoglobin (HGB) >=90 g/L, leukocytes (WBC) >=4×109 /L, platelets (PLT) >=90×109 /L (no blood transfusion and blood products within 14 days, not corrected with G-CSF and other hematopoietic stimulating factors). 9. Liver function: alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) < 1.5 times the upper limit of normal (ULN); Total bilirubin (TBIL) < 1.5 times the upper limit of normal (ULN). 10. Renal function: serum creatinine < 1.5 times the upper limit of normal (ULN); The creatinine clearance rate is not less than 60ml/min. 11. Myocardial markers within the normal range; Thyroid function is within the normal range. 12. In the judgment of the investigator, it is considered that the patient is able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1.Prior immunotherapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibodies, or any other antibodies or drugs targeting T-cell costimulatory or immune checkpoint pathways. 2.Known diagnosis of another malignancy. 3.Presence of peripheral neuropathy of grade 2 or higher, according to the NCI CTCAE v5.0. 4.History or current diagnosis of interstitial lung disease or non-infectious pneumonitis (except for localized radiation-induced pneumonitis). 5.Uncontrolled systemic diseases, including but not limited to diabetes, hypertension, or acute pulmonary disorders. 6.Active infections requiring systemic therapy, including active tuberculosis. 7.Significant cardiovascular disease, such as heart failure classified as NYHA class II or above, myocardial infarction within the past 3 months, unstable arrhythmias (including QT interval >=480 ms), or unstable angina. 8.Active hepatitis B or hepatitis C infection, defined by any of the following: positive HBsAg with peripheral blood HBV DNA titer >=1×10^3 copies/mL; positive HCV antibody with detectable HCV-RNA (above the lower limit of quantification for the assay). 9.History of immunodeficiency, including HIV positivity, any other acquired or congenital immunodeficiency disorder, or a history of organ transplantation. 10.Ongoing systemic corticosteroid therapy or any other form of immunosuppressive treatment, or active autoimmune disease that might be exacerbated by immune stimulation (except for patients with type I diabetes, vitiligo, psoriasis, hypothyroidism, or hyperthyroidism that do not require immunosuppressive treatment). 11.Major surgery within 4 weeks prior to treatment, or the presence of an unhealed wound, ulcer, or fracture. 12.Receipt of a live virus vaccine within 4 weeks prior to treatment (administration of non-live vaccines such as seasonal influenza vaccines and COVID-19 vaccines is permitted).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete Response Rate ;Progression-Free Survival;Overall Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Disease Control Rate;Duration of Response; | — |
Countries
China
Contacts
Public ContactWang Shanbing
Department of Oncology, the Second People's Hospital of Yibin City
Outcome results
None listed