Nimotuzumab Combined With Chemoradiotherapy Versus Chemoradiotherapy for Local Advanced Cervical Squamous Cell Carcinoma

NCT04678791 | Unknown

• 1 other identifier: M2020411
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 3-year progression-free survival (PFS)

  The rate of patient without progress disease in 3 years after treatment

  up to 3 years

Secondary Outcomes (4)

• 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

Study Arms (2)

Nimotuzumab+ chemoradiotherapy

EXPERIMENTAL

Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.

Drug: Nimotuzumab; Drug: Cisplatin; Radiation: External-beam radiation; Radiation: Brachytherapy

Chemoradiotherapy

ACTIVE COMPARATOR

Patients receive cisplatin and undergo external-beam radiation and brachytherapy

Drug: Cisplatin; Radiation: External-beam radiation; Radiation: Brachytherapy

Interventions

Nimotuzumab DRUG

Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.

Also known as: EGFR monoclonal antibody

Nimotuzumab+ chemoradiotherapy

Cisplatin DRUG

Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total

Also known as: Cisplatin injection

Chemoradiotherapy; Nimotuzumab+ chemoradiotherapy

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.

Chemoradiotherapy; Nimotuzumab+ chemoradiotherapy

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.

Chemoradiotherapy; Nimotuzumab+ chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Patients who are participating in other clinical trials or have stopped clinical trials for less than 4 weeks;
• Patients with known hypersensitivity to Nimotuzumab or its components;
• Patients with contraindications to cisplatin;
• Patients with neurological or psychiatric disorders affecting cognitive ability;
• Patients whose lesions cannot be treated with intracavitary radiotherapy as assessed by the investigator;

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University 3rd Hospital

Beijing, Beijng, 100191, China

Location

MeSH Terms

Interventions

nimotuzumab; Cisplatin; Brachytherapy

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Radiotherapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 22, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 22, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)