The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy versus placebo combined with concurrent chemoradiotherapy in patients with locally advanced cervical squamous cell carcinoma.
The primary hypotheses are that nimotuzumab plus concurrent chemoradiotherapy sequential maintenance therapy is superior to placebo plus concurrent chemoradiotherapy with respect to progression-free survival.
1.Aged 18-80 years old;
2.Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
3.At least one measurable lesion according to RECIST 1.1;
4.Absence of severe hematopoietic dysfunction and heart, lung, liver, kidney dysfunction and immunodeficiency, laboratory test results meet the following criteria: Hemoglobin ≥ 90 g/L; Absolute neutrophil count ≥ 1.5 × 10^9/L and white blood cell count ≥ 3.0 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN ; Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;
1.Cervical adenocarcinoma and rare pathological types of malignant tumors;
2.Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
3.Ureteral obstruction, inability to place ureteral stent or pyelostomy;
4.Pregnant or lactating women;
Parallel
Nimotuzumab
Biological/VaccineNimotuzumab 400mg
Cisplatin
DrugCisplatin 40mg/m\^2
External Beam Radiotherapy (EBRT)
RadiationExternal Beam Radiotherapy (EBRT)
Brachytherapy
RadiationBrachytherapy
placebo for Nimotuzumab
Drugplacebo for Nimotuzumab 400mg
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by by the Investigator
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first.
3-,5-Year Overall Survival (OS)
OS is the time from randomization to death due to any cause.
3-,5-Year Disease Free Survival(DFS)
DFS is defined as the time from randomization to disease recurrence or death due to any cause.
3-,5-Year Locoregional Recurrence-Free Survival(LRRFS)
Locoregional recurrence-free survival (LRRFS) was defined as the absence of either consistent or relapsed disease at the primary tumor site or the regional lymph nodes
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