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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.
This study adopts a multi-center, randomized controlled, open-label clinical trial design.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nimotuzumab+ chemoradiotherapy | Experimental | Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy. |
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| Chemoradiotherapy | Active Comparator | Patients receive cisplatin and undergo external-beam radiation and brachytherapy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nimotuzumab | Drug | Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 3-year progression-free survival (PFS) | The rate of patient without progress disease in 3 years after treatment | up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival (OS) | The rate of patient alive in 3 years after treatment | up to 3 years |
| Complete response rate (CRR) | Percentage of subjects in this group who achieve complete response by imaging assessment from the end of treatment to disease progression. |
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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;
Compliance is good and informed consent is voluntarily signed.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University 3rd Hospital | Beijing | Beijng | 100191 | China |
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| Cisplatin | Drug | Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total |
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| External-beam radiation | Radiation | Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f. |
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| Brachytherapy | Radiation | Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 ~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90. |
|
| 3 months later after treatment |
| Objective response rate (ORR) | The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment. | 3 months later after treatment |
| Incidence and severity of acute adverse events | Number and grade of participants with adverse events | up to 3 months complete treatment |
| ID | Term |
|---|---|
| C501466 | nimotuzumab |
| D002945 | Cisplatin |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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