Clinical trial NCT06771596: Nimotuzumab High-risk, Locally Advanced Squamous Cell Carcinoma of the Cervix
Official title: A Prospective, Single-arm Study on Nimotuzumab Combined With Concurrent Chemoradiotherapy for the Treatment of Locally Advanced High-risk Squamous Cell Carcinoma of the Cervix
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Uterine Cervical Neoplasms
Keywords: nimotuzumab
high-risk locally advanced cervical squamous cell carcinoma
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: The purpose of this study is to evaluate the efficacy and safety of nimotuzumab plus concurrent chemoradiotherapy in the treatment of high-risk locally advanced cervical squamous cell carcinoma.

This study adopts a single-arm design, and the primary efficacy endpoint is the 2-year progression-free survival (PFS) rate.

Eligibility criteria: Inclusion Criteria:

* 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):

  1. Absolute neutrophil count (ANC) ≥1.5×10\^9/L
  2. Platelet count ≥90×10\^9/L
  3. Hemoglobin level ≥90 g/L
  4. Serum albumin level ≥30 g/L
  5. Bilirubin level ≤1.5 times the upper limit of normal (ULN)
  6. Alanine transaminase (ALT) and aspartate transaminase (AST) levels ≤3×ULN
  7. Serum creatinine level ≤1.5×ULN
  8. Thyroid-stimulating hormone (TSH) level ≤1×ULN (with eligibility also extended to patients with free triiodothyronine \[FT3\] or free thyroxine \[FT4\] levels ≤1×ULN).
* For women of childbearing potential not undergoing surgical sterilization, a negative serum pregnancy test (hCG) within 72 hours prior to study randomization is required; breastfeeding must be absent. Additionally, the use of a medically approved contraceptive method is mandatory from the time of informed consent through the study treatment period and for 120 days following the final administration of the trial medication or 180 days after the last chemotherapy/ radiotherapy session. Participants must also agree not to donate eggs for reproductive purposes or to freeze/preserve eggs for this use during the aforementioned period.
* Informed consent must be obtained with documentation.
* Availability for follow-up assessments.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
timeFrame: 24 months
Secondary outcomes:
measure: Overall Survival (OS) at Month 24
timeFrame: 24 months
measure: Complete Response Rate
timeFrame: 3-6 months
measure: Objective Response Rate
timeFrame: 3-6 months
measure: Disease Control Rate
timeFrame: 3-6 months
measure: Duration of Response
timeFrame: 24 months
measure: Time to Progression
timeFrame: 24 months
measure: Number of Participants Who Experience One or More Adverse Events
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
name: Shuangzheng Jia, PhD
role: PRINCIPAL_INVESTIGATOR
References: