Cervical Cancer
Conditions
Interventions
Intervention group:Serplulimab + Nab-paclitaxel + Cisplatin + Capecitabine for 2 cycles
followed by concurrent chemoradiotherapy (Cisplatin 40mg/m2, d1, once weekly for 4–6 cycles) after completion of the two cycles of neoadjuvant chemotherapy
Sponsors
Huizhou Central People‘s Hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Age 18-70 years; 2.Cervical cancer diagnosed by pathological tissue examination as squamous cell carcinoma, adenocarcinoma or adenocarcinoma-squamous cell carcinoma; 3.FIGO 2018 stage IB3IIA2IIBIIIAIIIBIIIC1rIIIC2rIVA; 4.ECOG PS 0-1; 5.Adequate organ function: haematology: absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, haemoglobin >= 90 g/L; liver function: total bilirubin = 40 mL/min;adequate heart function:left ventricular ejection fraction (LVEF) >= 50%; 6.Signed written informed consent must be obtained prior to the implementation of any trial-related procedures(be able to Comply with the informed consent form (ICF) and the requirements and restrictions listed in the protocol); 7.Be able to be followed up and have good compliance.
Exclusion criteria
Exclusion criteria: 1.Prior anticancer therapy before the start of this trial; 2.Pregnant or lactating women; 3.History of allergy to any of the following drugs: serplulimab, nab-paclitaxel, cisplatin, or capecitabine; 4.History of other malignancies within the past 5 years or concurrent presence of another malignancy; 5.Uncontrolled cardiac clinical symptoms or diseases, such as: (1) Heart failure of NYHA Class II or above; (2) Unstable angina; (3) Myocardial infarction within the past year; (4) Patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 6.Receipt of any of the following treatments: (1). Any investigational drug prior to the first dose of the study drug; (2).Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) study or the follow-up phase of an interventional study; (3). Systemic treatment with corticosteroids (at a dose >10 mg prednisone equivalent per day) or other immunosuppressants within 2 weeks prior to the first dose of the study drug, excluding the use of corticosteroids for local inflammation, prevention of allergies, nausea, and vomiting. Inhaled or topical steroids and adrenal corticosteroid replacement at doses >10 mg prednisone equivalent per day are permitted in the absence of active autoimmune disease; (4). Administration of anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the study drug; (5). Major surgery or severe trauma within 4 weeks prior to the first dose of the study drug; 7.Severe infection (CTCAE Grade >2) within 4 weeks prior to the first dose of the study drug (e.g., severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.); or chest imaging at baseline suggesting active pulmonary inflammation; or presence of signs/symptoms of infection within 2 weeks prior to the first dose of the study drug, or requiring oral/intravenous antibiotic therapy (excluding prophylactic use of antibiotics); 8.Active autoimmune diseases (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these disorders/syndromes), excluding vitiligo or resolved childhood asthma/allergies that require no intervention in adulthood; 9.History of immunodeficiency, including HIV positivity, or other acquired/congenital immunodeficiency diseases, or history of organ transplant or hematopoietic stem cell transplant; 10.Evidence of active tuberculosis infection by history or CT examination, or history of active tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without adequate treatment; 11.Active hepatitis (HBV DNA >=2000 IU/mL or 10,000 copies/mL) or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay); 12.Known history of substance abuse, alcohol abuse, or drug addiction; 13.Inability to understand the study requirements or potential non-compliance with the study procedures; 14.Considered by the investigator to be unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 1-year Progression-Free Survival (PFS) rates;2-year Progression-Free Survival (PFS) rates;1-year Overall Survival (OS) rates;2-year Overall Survival (OS) rates;Clinical Complete Response (cCR) rate;Pattern of recurrence;Treatment completion rate;Incidence and severity of Adverse Events (AEs); | — |
Countries
China
Contacts
Public ContactFuchuan Xie
Huizhou Central People‘s Hospital
Outcome results
None listed