Nimotuzumab High-risk, Locally Advanced Squamous Cell Carcinoma of the Cervix

NCT06771596 | Active Not Recruiting Phase 2

• 2 other identifiers: BPL-IST-CC-20210304Y-QL202101-0108
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

The efficacy and safety of nimotuzumab in the treatment of high-risk, locally advanced squamous cell carcinoma of the cervix.

Conditions

Uterine Cervical Neoplasms

Keywords

nimotuzumab; high-risk locally advanced cervical squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. The appearance of one or more new lesions is also considered PD. Unequivocal progression of non-target lesions is also considered PD.

  24 months

Secondary Outcomes (7)

• Overall Survival (OS) at Month 24

  24 months

• Complete Response Rate

  3-6 months

• Objective Response Rate

  3-6 months

• Disease Control Rate

  3-6 months

• Duration of Response

  24 months

Study Arms (1)

chemoradiotherapy + nimotuzumab

EXPERIMENTAL

Participants receive nimotuzumab 400 mg intravenously (IV) on Day 1 of each week cycle (QW) for 4-6 cycles . During the period of nimotuzumab, participants receive concurrent chemoradiotherapy. The standard of care chemoradiotherapy regimen includes cisplatin 40 mg/m\^2 IV once per week (QW) for 4- 6 weeks plus external beam radiotherapy (EBRT) followed by brachytherapy .The cumulative dose at Point A/HRCTV D90 should be equal to or greater than 87 Gy EQD2Gy. The combination of brachytherapy and external beam radiotherapy should be completed within 8 weeks.

Drug: Nimotuzumab Injection

Interventions

Nimotuzumab Injection DRUG

Nimotuzumab is a highly humanized monoclonal antibody of IgG1 type, with a humanization rate of 95%. It is highly specific, has a long half - life, and shows high selectivity and a high degree of humanization. It can specifically block the epidermal growth factor receptor (EGFR) signaling pathway and mediate immune effects such as antibody - dependent cell - mediated cytotoxicity (ADCC) and complement - dependent cytotoxicity (CDC). It also promotes the endocytosis and degradation of EGFR, thereby inhibiting the proliferation of tumor cells and promoting the apoptosis of tumor cells, reversing the malignant biological behavior of tumor cells at the molecular level.

Also known as: Nimotuzumab

chemoradiotherapy + nimotuzumab

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 between 18 and 75 years old.
• Newly diagnosed cervical squamous cell carcinoma confirmed by histology, with a clinical stage of stage III - IVA (FIGO 2018 staging).
• No prior receipt of surgery, radiotherapy, or systemic anticancer therapy for the treatment of cervical cancer.
• No previous exposure to the study drug.
• Presence of at least one measurable or evaluable lesion as per RECIST version 1.1, with the measurable lesion exhibiting a longest diameter of ≥10 mm on spiral CT scan or a shortest diameter of ≥15 mm for enlarged lymph nodes, which has not been previously irradiated.
• Absence of central nervous system diseases, both primary and metastatic.
• WHO/ECOG performance status score of 0-1.
• Anticipated survival duration of at least 12 weeks.
• Adequate organ function within the following parameters (without the use of any blood components, cytokines, or growth factors within 14 days prior to randomization):
• Absolute neutrophil count (ANC) ≥1.5×10\^9/L
• Platelet count ≥90×10\^9/L
• Hemoglobin level ≥90 g/L
• Serum albumin level ≥30 g/L
• Bilirubin level ≤1.5 times the upper limit of normal (ULN)
• Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≤3×ULN

You may not qualify if:

• Cervical adenocarcinoma and other rare pathological types.
• Having previously received surgical treatment, pelvic radiotherapy, systemic chemotherapy, tumor targeted therapy, or immunotherapy for cervical cancer.
• Bilateral hydronephrosis, unless resolved by unilateral stent placement or percutaneous nephrostomy, or deemed mild and without clinical significance by the investigator.
• Pregnant women or those in the lactation period.
• With rectovaginal fistula/vaginal vesical fistula/uncontrolled massive vaginal bleeding or at risk of developing a fistula.
• Active infectious processes necessitating antimicrobial therapy, including the use of antibacterial, antiviral, or antifungal agents.
• History of immunodeficiency, including HIV seropositivity or other acquired and congenital immunodeficiency disorders.
• Uncontrolled cardiac symptoms or diseases, such as NYHA class II or higher heart failure, unstable angina, myocardial infarction within the past year, atrial fibrillation, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, PR interval greater than 250 ms, or QTc interval ≥470 ms.
• History of other malignant tumors (except for cured basal cell carcinoma of the skin).
• Crohn's disease or ulcerative colitis.
• Allergic to nimotuzumab or its components.
• contraindications for cisplatin use.
• Neurological or mental disorders affecting cognitive ability.
• Unable to receive intracavitary radiotherapy.
• Other reasons not suitable for participating in this study.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

nimotuzumab

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Shuangzheng Jia, PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Ph. D.

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 13, 2025
• Study Start: May 12, 2021
• Primary Completion: July 1, 2025
• Study Completion: September 1, 2025
• Last Updated: January 13, 2025

Record last verified: 2025-01

Locations

CN (1)