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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Cervical Squamous Cell Carcinoma
• Intervention / Treatment: Drug: Nimotuzumab; Drug: Cisplatin; Radiation: External-beam radiation; Radiation: Brachytherapy

Detailed Description

This study adopts a multi-center, randomized controlled, open-label clinical trial design.

• Study Type: Interventional
• Enrollment (Anticipated): 286
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijng
    • Beijing, Beijng, China, 100191
      • Peking University 3rd Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nimotuzumab+ chemoradiotherapy; Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.	Drug: Nimotuzumab; Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.; Other Names: EGFR monoclonal antibody; Drug: Cisplatin; Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total; Other Names: Cisplatin injection; Radiation: External-beam 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.; Radiation: Brachytherapy; 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.
Active Comparator: Chemoradiotherapy; Patients receive cisplatin and undergo external-beam radiation and brachytherapy	Drug: Cisplatin; Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total; Other Names: Cisplatin injection; Radiation: External-beam 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.; Radiation: Brachytherapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2020
• Primary Completion (Anticipated): December 1, 2024
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (Actual): December 22, 2020

Study Record Updates

• Last Update Posted (Actual): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell; Antineoplastic Agents; Antineoplastic Agents, Immunological; Cisplatin; Nimotuzumab
• Other Study ID Numbers: M2020411

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No