Cervical cancer
Conditions
Interventions
Putli mab group:One course of Putli mab induction therapy, combined with chemoradiotherapy followed by single-agent maintenance therapy for locally advanced cervical cancer.
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Female, aged >=18 years; 2.Histologically/cytologically confirmed locally advanced cervical cancer, which is squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 3.Pathological diagnosis: FIGO 2018 stage ?B3, ?A2, ?B-?A; 4.At least one measurable lesion at baseline, meeting the RECIST 1.1 criteria for target lesions. Tumor assessment must be performed by CT scan or MRI within 28 days before enrollment; 5.No prior receipt of any radical surgery, radiotherapy, or systemic therapy (including investigational drugs) for cervical cancer, and no prior receipt of immunotherapy; 6.Participants must have adequate organ function, defined as follows: - Hemoglobin >= 9.0 g/dL - Absolute neutrophil count >= 1.5 × 10^9/L - Platelet count >= 75 × 10^9/L - Serum bilirubin = 60 mL/min, calculated by the Cockcroft-Gault formula (using actual body weight) or measured by 24-hour urine collection. For females: Creatinine CL = [Body weight (kg) × (140 - age) × 0.85 (mL/min)] / [72 × serum creatinine (mg/dL)]; 7.Female participants with childbearing potential must have a negative serum pregnancy test within 72 hours before receiving the study treatment and agree to use contraception for 150 days after the last dose of study treatment, or have no childbearing potential. Male partners must agree to use appropriate contraceptive methods from the first dose of study treatment until 150 days after the last dose of study treatment; 8.Participants must agree not to breastfeed during the study or within 150 days after the last treatment; 9.Participants must be able to understand the study procedures and agree to participate by providing written informed consent; 10.ECOG performance status 0-1; 11.Life expectancy >= 3 months.
Exclusion criteria
Exclusion criteria: 1.Histological types other than those specified in the inclusion criteria, such as sarcomas, small cell carcinomas with neuroendocrine differentiation, and non-epithelial carcinomas; 2.Subjects who have undergone hysterectomy; 3.A history of autoimmune diseases, idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia, idiopathic pneumonia, a history of interstitial lung disease with a history of active pneumonia detected by chest CT scan, or active tuberculosis; 4.Lactating or pregnant women; 5.Previous treatment with anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, or anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibodies; 6.Subjects with known previous allergies to macromolecular protein preparations/monoclonal antibodies, or known allergies to any components of the study drugs; 7.Those requiring systemic corticosteroid therapy (at a dose equivalent to or higher than 10 mg/day prednisone) or other immunosuppressive drugs within 14 days before enrollment or during the study period; 8.Those who received live vaccine within 4 weeks before the start of treatment; 9.Those who have received anti-tumor vaccines or anti-tumor treatments with systemic immune-stimulating effects; 10.Previous allogeneic hematopoietic stem cell transplantation or solid organ transplantation; 11.A history of alcoholism, drug addiction, or substance abuse within the past year; 12.A clear history of neurological or psychiatric disorders such as epilepsy, dementia, or poor compliance; 13.Other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participating in the study and receiving study drugs, or may interfere with the interpretation of study results; 14.Participants with severe, uncontrolled diseases or non-malignant systemic diseases. For example: uncontrolled ventricular arrhythmias, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizures, unstable spinal cord compression, superior vena cava syndrome; 15.Participants with a known history of human immunodeficiency virus (HIV).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate(ORR);Complete Response Rate(CRR);Progression-Free Survival(PFS);Overall Survival(OS);Safety and Tolerability; | — |
Countries
China
Contacts
Public ContactXin Jiang
The First Hospital of Jilin University
Outcome results
None listed