A Phase I/II Study of Chemoradiotherapy Using Albumin-Bound Paclitaxel and Cisplatin in Unresectable Esophageal Squamous Cell Carcinomas Based on Nutritional Risk Screening Score (NRS2002)

This Phase I/II clinical study is meticulously designed to assess the one-year local tumor control rate of a chemoradiotherapy regimen that combines albumin-bound paclitaxel and cisplatin in patients with unresectable esophageal squamous cell carcinoma (ESCC). The selection of participants is guided by the Nutritional Risk Screening (NRS2002) tool, which ensures that nutritional risk factors are adequately considered and managed throughout the study.

The trial will enroll patients diagnosed with unresectable ESCC, a condition where surgical intervention is not feasible due to the tumor's location, size, or patient comorbidities. Participants will undergo a thorough nutritional assessment using the NRS2002 criteria, which evaluates factors such as weight loss, body mass index, dietary intake, and severity of disease to determine their nutritional risk score. This screening is crucial as it helps identify patients who may benefit from nutritional interventions, which could potentially improve their overall response to the treatment and quality of life.

Once enrolled, patients will receive a combination chemoradiotherapy of albumin-bound paclitaxel and cisplatin. Albumin-bound paclitaxel is chosen for its ability to improve the delivery and efficacy of paclitaxel, a chemotherapy drug, by enhancing its solubility and distribution within the body. Cisplatin, a platinum-based chemotherapy agent, is included due to its well-established efficacy in treating various cancers, including esophageal cancer. This combination aims to maximize tumor reduction while managing potential side effects.

The primary endpoint of the study is to determine the local tumor control rate at one year, which refers to the percentage of patients whose tumors have not progressed or recurred within the treated area during this period. Secondary endpoints include overall survival, progression-free survival, and assessment of treatment-related toxicity. Additionally, the study will monitor changes in patients' nutritional status and quality of life, aiming to provide comprehensive insights into the efficacy and safety of this chemoradiotherapy regimen.

Regular follow-ups and imaging studies, such as CT scans or PET scans, will be conducted to evaluate the tumor response and detect any signs of progression. Blood tests and other laboratory assessments will be performed periodically to monitor patients' overall health and manage any adverse effects promptly. The data collected from this study will contribute valuable information to the ongoing efforts to improve treatment outcomes for patients with unresectable esophageal squamous cell carcinoma.