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Published on: April 22, 2019
Nimotuzumab Plus Image-Guided Radiation Therapy for Elderly Patients with Locally Advanced Cervical Squamous Cell
Ang Qu1, Yanhong Zhuo2, Hong Zhu3
1Peking University Third Hospital, Beijing, China.
Purpose:
Elderly patients with locally advanced cervical squamous cell carcinoma (LACSCC) generally have fewer therapeutic choices. Nimotuzumab, as an epidermal growth factor receptor-targeted humanized monoclonal antibody, has low toxicity, and shown antitumor efficacy in cervical cancer in preliminary study. Therefore, we wanted to explore efficacy and safety of nimotuzumab and image-guided radiation therapy for elderly patients with LACSCC.
Methods And Materials:
This is a prospective, multicenter, open-label, single-arm, and phase II trial. LACSCC patients aged ≥ 65 years not receiving chemotherapy were enrolled. All of the patients received intensity-modulated radiation therapy and image-guided brachytherapy. Nimotuzumab was administration of 200 mg once a week for 6 weeks. Disease-free survival (DFS) is the primary endpoint. Secondary endpoints included overall survival (OS), complete response rate, objective response rate, and safety.
Results:
From November 2021 to January 2023, a total of 118 elder patients with stage IB3-IVA were enrolled. The median follow-up was 24 months (95% CI: 21.78, 25.53). The complete response rate was 61.86% (95% CI, 0.53-0.71), objective response rate was 91.53% (95% CI, 0.85-0.96). The 1 year-DFS and 2 year-DFS were 92.42% (95% CI, 85.40-96.14) and 84.61% (95% CI, 75.07-90.72), respectively, the median DFS was 36.99 months (95% CI, NA, NA). The 1 year-OS was 96.19% (95% CI, 90.15-98.55), 2 year-OS was 88.22% (95% CI, 78.87-93.60), the median OS was not reached. The most common grade 3 adverse events included leukopenia (4/30.77%), neutropenia (3/23.08%), lymphopenia (2/15.38%), diarrhea (1/7.69%), and anemia (3/23.08%). No drug-related severe adverse events or deaths were recorded.
Conclusions:
Among elderly LACSCC patients, nimotuzumab plus image-guided radiation therapy and brachytherapy was well tolerated and indicated promising clinical survival benefits. The robustness of efficacy and toxicity results might provide a novel treatment option for this population.
Insights
Nimotuzumab combined with image-guided radiotherapy offers promising survival benefits for elderly patients with locally advanced cervical squamous cell carcinoma (LACSCC). This treatment approach demonstrated good tolerability and efficacy in a phase II trial.
Area of Science:
- Oncology
- Radiotherapy
- Immunotherapy
Background:
- Elderly patients with locally advanced cervical squamous cell carcinoma (LACSCC) have limited treatment options.
- Nimotuzumab, an EGFR-targeted antibody, shows potential antitumor activity with low toxicity.
- Preliminary studies suggest efficacy in cervical cancer, warranting further investigation.
Purpose of the Study:
- To evaluate the efficacy and safety of nimotuzumab combined with image-guided radiotherapy in elderly LACSCC patients.
- To explore nimotuzumab as a therapeutic option for a population with restricted choices.
Main Methods:
- Prospective, multicenter, open-label, single-arm, phase II clinical trial.
- Enrolled LACSCC patients aged ≥65 years not receiving chemotherapy.
- Treatment included intensity-modulated radiotherapy, image-guided brachytherapy, and weekly nimotuzumab (200 mg for 6 weeks).
- Primary endpoint: disease-free survival (DFS); Secondary endpoints: overall survival (OS), response rates, and safety.
Main Results:
- 118 elderly patients with LACSCC (Stage IB3-IVA) were enrolled.
- Median follow-up was 24 months.
- Complete response rate (CRR) was 61.86%, objective response rate (ORR) was 91.53%.
- 1-year DFS was 92.42%, 2-year DFS was 84.61%.
- 1-year OS was 96.19%, 2-year OS was 88.22%.
- Common Grade 3 adverse events included leukopenia and neutropenia; no severe drug-related AEs or deaths were reported.
Conclusions:
- Nimotuzumab plus image-guided radiotherapy and brachytherapy is well-tolerated in elderly LACSCC patients.
- The combination therapy shows promising clinical survival benefits.
- This regimen may represent a novel treatment option for this patient group.
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