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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04678791
• Collaborator: (none)
• Enrollment: 286
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Squamous Cell Carcinoma	Drug: Nimotuzumab; Drug: Cisplatin; Radiation: External-beam radiation; Radiation: Brachytherapy	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 286 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Dec 1, 2020
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 3-year progression-free survival (PFS) [up to 3 years]

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

Secondary Outcome Measures

1. 3-year overall survival (OS) [up to 3 years]

   The rate of patient alive in 3 years after treatment

2. Complete response rate (CRR) [3 months later after treatment]

   Percentage of subjects in this group who achieve complete response by imaging assessment from the end of treatment to disease progression.

3. Objective response rate (ORR) [3 months later after treatment]

   The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.

4. Incidence and severity of acute adverse events [up to 3 months complete treatment]

   Number and grade of participants with adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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;

1. ECOG score 0-2 points;

2. Expected survival ≥ 3 months;

3. 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);

4. No intrauterine device;

5. Women of childbearing potential who are willing to take medically recognized contraceptive measures during the trial;

6. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University 3rd Hospital	Beijing	Beijng	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Junjie Wang, Principal Investigator, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04678791
• Other Study ID Numbers: M2020411
• First Posted: Dec 22, 2020
• Last Update Posted: Dec 22, 2020
• Last Verified: Dec 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Cisplatin; Nimotuzumab

Study Results

No Results Posted as of Dec 22, 2020