To hear about similar clinical trials, please enter your email below
Trial Title:
A Study of Nimotuzumab Plus Concurrent Chemoradiotherapy Sequential Maintenance Treatment for Cervical Carcinoma
NCT ID:
NCT06333821
Condition:
Cervical Cancer
Conditions: Official terms:
Carcinoma
Uterine Cervical Neoplasms
Nimotuzumab
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This is a multicenter prospective, randomized, double-blind, placebo-controlled phase III
trial
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Masking description:
This study is double-blind and will blind both the investigator and the subjects. All
participants in the study (including data managers and biostatisticians) will be unaware
of treatment assignment (except blind statisticians).
Intervention:
Intervention type:
Biological
Intervention name:
Nimotuzumab
Description:
Nimotuzumab 400mg
Arm group label:
Nimotuzumab+chemoradiotherapy
Intervention type:
Drug
Intervention name:
Cisplatin
Description:
Cisplatin 40mg/m^2
Arm group label:
Nimotuzumab+chemoradiotherapy
Arm group label:
placebo for Nimotuzumab+chemoradiotherapy
Intervention type:
Radiation
Intervention name:
External Beam Radiotherapy (EBRT)
Description:
External Beam Radiotherapy (EBRT)
Arm group label:
Nimotuzumab+chemoradiotherapy
Arm group label:
placebo for Nimotuzumab+chemoradiotherapy
Intervention type:
Radiation
Intervention name:
Brachytherapy
Description:
Brachytherapy
Arm group label:
Nimotuzumab+chemoradiotherapy
Arm group label:
placebo for Nimotuzumab+chemoradiotherapy
Intervention type:
Drug
Intervention name:
placebo for Nimotuzumab
Description:
placebo for Nimotuzumab 400mg
Arm group label:
placebo for Nimotuzumab+chemoradiotherapy
Other name:
placebo
Summary:
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.
Detailed description:
This is a multicenter, prospective, randomized, double-blind, placebo-controlled clinical
study.The trail will enroll 460 subjects (FIGO 2018, stageIB3-IVA)who meet enrollment
criteria but do not meet exclusion criteria. According to clinical stage (FIGO 2018
stage, stage IB3-IIB or III-IVA) 、tumor diameter (>4cm or ≤4cm)、 age (≥18 years and < 65
years old or ≥65 years old and ≤80 years old) for stratified randomization. They are
divided into experimental group and control group according to 1:1. Patients in the
experimental group will receive nimotuzumab 400mg on the basis of concurrent
chemoradiotherapy, once a week for 7-8 weeks, and then maintenance treatment once every 2
weeks for 24 weeks. Using placebo(Nimotuzumab injection mimics) in the control group 80
ml on the basis of concurrent chemoradiotherapy, once a week for 7 to 8 weeks, after the
maintenance treatment, once every 2 weeks for 24 weeks. Patients with incomplete tumor
response assessed by imaging and pathological examination 3 months after radiotherapy can
be given 2-4 cycles of adjuvant chemotherapy with cisplatin/carboplatin combined with
paclitaxel regimen. Regular imaging examination and survival follow-up were performed
after treatment. The primary efficacy end point was progression-free survival.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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;
- 5.ECOG score 0-1 points;
- 6.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); Women of childbearing
potential who are willing to take medically recognized contraceptive measures during
the trial;
- 7.Compliance is good and informed consent is voluntarily signed.
Exclusion Criteria:
- 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;
- 5.Patients with rectovaginal fistula/vaginovesical fistula/uncontrolled vaginal
bleeding or at risk of fistula;
- 6.Had undergone major surgery (except biopsy) within 4 weeks prior to randomization;
- 7.Had received a live vaccine within 4 weeks prior to the initial study drug
treatment or planned to vaccinate during the study;
- 8.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);
- 9.Had the following serious medical conditions: a) Uncontrolled hypertension
(defined as systolic blood pressure > 150 mmHg or diastolic blood pressure > 100
mmHg), or had experienced a hypertensive crisis; b) Myocardial infarction and
unstable angina occurred within 6 months before randomization; c) Decompensated
heart failure within three months before enrollment (NYHA class III and IV); d) The
presence of severe arrhythmias requiring long-term medical intervention, except in
patients with asymptomatic atrial fibrillation with stable ventricular rate; e) Left
ventricular ejection fraction (LVEF)<50%; f) The presence of uncontrolled
hyperglycemia; g) The presence of uncontrollable infections;
- 10.The presence of active or suspected autoimmune diseases, except for type 1
diabetes、hypothyroidism or skin conditions that do not require systemic treatment
(vitiligo、psoriasis or alopecia);
- 11.Conditions requiring systemic treatment with corticosteroids or other
immunosuppressive agents within 14 days before randomization;
- 12.Patients with a history of other malignant tumors (except cured cutaneous basal
cell carcinoma);
- 13.Patients with Crohn's disease and ulcerative colitis;
- 14.Patients who are participating in other clinical trials or have stopped clinical
trials for less than 4 weeks;
- 15.Patients with known hypersensitivity to Nimotuzumab or its components;
- 16.Patients with contraindications to cisplatin、carboplatin and paclitaxel;
- 17.Patients with neurological or psychiatric disorders affecting cognitive ability;
- 18.Patients whose lesions cannot be treated with intracavitary radiotherapy as
assessed by the investigator;
- 19.Any condition that, in the opinion of the Investigator, may be inappropriate for
patients in the study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Start date:
April 1, 2024
Completion date:
April 1, 2030
Lead sponsor:
Agency:
Biotech Pharmaceutical Co., Ltd.
Agency class:
Other
Source:
Biotech Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06333821