Clinical trial NCT04678791: Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cervical Squamous Cell Carcinoma
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 286
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18-75 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 ≥ 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;
5. ECOG score 0-2 points;
6. Expected survival ≥ 3 months;
7. 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);
8. No intrauterine device;
9. Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;
10. 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. Human immunodeficiency virus (HIV) infection;
7. 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);
8. 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;
9. Patients with a history of other malignant tumors (except cured cutaneous basal cell carcinoma);
10. Patients with Crohn's disease and ulcerative colitis;
11. Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
12. Patients with known hypersensitivity to Nimotuzumab or its components;
13. Patients with contraindications to cisplatin;
14. Patients with neurological or psychiatric disorders affecting cognitive ability;
15. Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;
16. Other reasons that, in the judgment of the investigator, would make the patient inappropriate for the study.

Primary outcomes:
measure: 3-year progression-free survival (PFS)
timeFrame: up to 3 years
Secondary outcomes:
measure: 3-year overall survival (OS)
timeFrame: up to 3 years
measure: Complete response rate (CRR)
timeFrame: 3 months later after treatment
measure: Objective response rate (ORR)
timeFrame: 3 months later after treatment
measure: Incidence and severity of acute adverse events
timeFrame: up to 3 months complete treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University 3rd Hospital
state: Beijng
Study officials:
References: