The efficacy and safety of nimotuzumab in the treatment of high-risk, locally advanced squamous cell carcinoma of the cervix.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
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.
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
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.
Time frame: 24 months
Overall Survival (OS) at Month 24
OS is the time from randomization to death due to any cause. OS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the OS rate at Month 24 using the entire OS data up to the cut-off date.
Time frame: 24 months
Complete Response Rate
Complete response refers to the situation where, after treatment, all target lesions (in the evaluation of cancer treatment, these are the tumor sites that are predetermined for observing and assessing the curative effect) completely disappear, no new lesions emerge, and the tumor markers (if there are relevant markers for evaluating the disease) return to normal levels. The complete response rate refers to the proportion of patients who have achieved a complete response state among all the patient groups receiving treatment.
Time frame: 3-6 months
Objective Response Rate
The Objective Response Rate (ORR) is an important indicator for measuring the effectiveness of cancer treatment. It refers to the proportion of patients whose tumors shrink to a predefined value and can maintain it for the minimum time requirement. Specifically, it includes patients with complete response (CR) and partial response (PR). As mentioned before, complete response means that all target lesions completely disappear, no new lesions appear, and the relevant tumor markers are normal. Partial response refers to the situation where the product of the maximum diameter and its maximum perpendicular diameter of a single tumor lesion (for a single lesion) or the sum of the maximum diameters of all target lesions (for multiple lesions) shrinks by a certain proportion (usually more than 30%), while no new lesions appear and there is no progression of non-target lesions.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3-6 months
Disease Control Rate
The Disease Control Rate (DCR) is a crucial indicator for evaluating the effectiveness of cancer treatment. It refers to the proportion of patients whose tumors achieve complete response (CR), partial response (PR), and stable disease (SD) among the total number of patients after treatment. Stable disease means that the product of the maximum diameter and its maximum perpendicular diameter of a single tumor lesion (for a single lesion) or the sum of the maximum diameters of all target lesions (for multiple lesions) neither shrinks to an extent sufficient to be judged as partial response nor enlarges to an extent sufficient to be judged as progressive disease (PD), and at the same time, no new lesions appear.
Time frame: 3-6 months
Duration of Response
The duration of response refers to the time interval starting from the time when the tumor was first recorded to meet the response criteria (complete response, CR or partial response, PR), and ending at the time when the tumor was first found to have progressive disease (PD) or when death occurred due to any reason.
Time frame: 24 months
Time to Progression
Time to Progression (TTP) refers to the time from when a patient starts receiving treatment to when the tumor shows progressive disease (PD).
Time frame: 24 months
Number of Participants Who Experience One or More Adverse Events
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Time frame: 24 months