To Investigate the Efficacy and Safety of Nimotuzumab Combined With Concurrent Chemoradiotherapy Versus Concurrent Chemoradiotherapy in the Treatment of Local Advanced Cervical Squamous Cell Carcinoma
Overview
- Phase
- Not Applicable
- Intervention
- Nimotuzumab
- Conditions
- Cervical Squamous Cell Carcinoma
- Sponsor
- Peking University Third Hospital
- Enrollment
- 286
- Locations
- 1
- Primary Endpoint
- 3-year progression-free survival (PFS)
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
To investigate the efficacy and safety of nimotuzumab combined with concurrent chemoradiotherapy versus concurrent chemoradiotherapy in the treatment of local advanced cervical squamous cell carcinoma.
Detailed Description
This study adopts a multi-center, randomized controlled, open-label clinical trial design.
Investigators
Junjie Wang
Principal Investigator
Peking University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •Aged 18-75 years old;
- •Histologically diagnosed primary cervical squamous cell carcinoma, with clinical stage IB3-IVA (FIGO 2018);
- •At least one measurable lesion according to RECIST 1.1;
- •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 ≥ 2 × 109/L or white blood cell count ≥ 4.0 × 109/L; Platelet count ≥ 100 × 109/L; Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN Total bilirubin ≤ 1.5 × ULN; Serum creatinine ≤ 1.0 × ULN;
- •ECOG score 0-2 points;
- •Expected survival ≥ 3 months;
- •Women of childbearing potential must have a negative serum or urine HCG within 72 hours prior to enrollment (postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential. A pregnancy test is not required for women who have demonstrated tubal ligation);
- •No intrauterine device;
- •Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;
Exclusion Criteria
- •Cervical adenocarcinoma and rare pathological types of malignant tumors;
- •Previous surgery for cervical cancer, pelvic radiation therapy, systemic chemotherapy, tumor targeted therapy, immunotherapy;
- •Ureteral obstruction, inability to place ureteral stent or pyelostomy;
- •Pregnant or lactating women;
- •Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal bleeding or at risk of fistula;
- •Human immunodeficiency virus (HIV) infection;
- •Active hepatitis B (the quantitative detection result of HBV DNA exceeds the lower limit of detection), or HCV infection (the quantitative detection result of HCV RNA exceeds the lower limit of detection);
- •Patients have a serious underlying condition that precludes safe administration of trial treatment. Including but not limited to active infection requiring systemic drug therapy: decompensated heart failure (NYHA Class III and IV), unstable angina pectoris, acute myocardial infarction within 3 months prior to enrollment;
- •Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
- •Patients with Crohn's disease and ulcerative colitis;
Arms & Interventions
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Intervention: Nimotuzumab
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Intervention: Cisplatin
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Intervention: External-beam radiation
Nimotuzumab+ chemoradiotherapy
Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Intervention: Brachytherapy
Chemoradiotherapy
Patients receive cisplatin and undergo external-beam radiation and brachytherapy
Intervention: Cisplatin
Chemoradiotherapy
Patients receive cisplatin and undergo external-beam radiation and brachytherapy
Intervention: External-beam radiation
Chemoradiotherapy
Patients receive cisplatin and undergo external-beam radiation and brachytherapy
Intervention: Brachytherapy
Outcomes
Primary Outcomes
3-year progression-free survival (PFS)
Time Frame: up to 3 years
The rate of patient without progress disease in 3 years after treatment
Secondary Outcomes
- 3-year overall survival (OS)(up to 3 years)
- Complete response rate (CRR)(3 months later after treatment)
- Objective response rate (ORR)(3 months later after treatment)
- Incidence and severity of acute adverse events(up to 3 months complete treatment)