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

Not Applicable

Not yet recruiting

• Conditions: Cervical Squamous Cell Carcinoma
• Interventions: Drug: Nimotuzumab; Radiation: External-beam radiation; Drug: Cisplatin; Radiation: Brachytherapy

• Registration Number: NCT04678791
• Lead Sponsor: Peking University Third Hospital

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.

Study Timeline

• Status Verified: 2020-12
• Study Start: 2020-12
• Study First Submitted: 2020-12-16
• Study First Submitted QC: 2020-12-16
• Last Update Submitted: 2020-12-16
• Study First Posted: 2020-12-22
• Last Update Posted: 2020-12-22
• Primary Completion: 2024-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 286

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy	External-beam radiation	Patients receive cisplatin and undergo external-beam radiation and brachytherapy
Nimotuzumab+ chemoradiotherapy	Nimotuzumab	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Nimotuzumab+ chemoradiotherapy	External-beam radiation	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Nimotuzumab+ chemoradiotherapy	Brachytherapy	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Chemoradiotherapy	Brachytherapy	Patients receive cisplatin and undergo external-beam radiation and brachytherapy
Nimotuzumab+ chemoradiotherapy	Cisplatin	Patients receive nimotuzumab combined with cisplatin and undergo external-beam radiation and brachytherapy.
Chemoradiotherapy	Cisplatin	Patients receive cisplatin and undergo external-beam radiation and brachytherapy

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
3-year overall survival (OS)	up to 3 years	The rate of patient alive in 3 years after treatment
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.
Objective response rate (ORR)	3 months later after treatment	The percentage of patients who experienced complete or partial cancer shrinkage or disappearance after treatment.
Incidence and severity of acute adverse events	up to 3 months complete treatment	Number and grade of participants with adverse events

Trial Locations

Locations (1)

Peking University 3rd Hospital; 🇨🇳 Beijing, Beijng, China