Chemoradiotherapy in Unresectable Esophageal Cancer

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Feb 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with unresectable (non-removable) esophageal cancer, specifically targeting esophageal squamous cell carcinoma. Researchers want to see how well a combination of two chemotherapy drugs—albumin-bound paclitaxel and cisplatin—works when given along with radiation therapy. The goal is to find out how effectively this treatment can control the tumor over the course of one year.

To participate in this study, individuals should be between 18 and 75 years old and have a confirmed diagnosis of unresectable esophageal squamous cell carcinoma, meeting certain staging criteria. They should also be generally healthy, with no serious ongoing illnesses, and must not have distant metastasis (spread of cancer to other body parts). Participants will be monitored closely throughout the trial and will need to provide informed consent to join. If you or a loved one is considering this trial, it could be an opportunity to access a new treatment while contributing to important cancer research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18\~75 years
• • Pathologically or cytologically proven unresectable esophageal squamous cell carcinomas in patients staged as T3N1M0-1b and T4N0-1M0-1b(AJCC 6th TNM staging,M1b limited to clavicular or celiac lymph node metastasis)
• • Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences
• • ECOG PS score: 0\~1
• • NRS2002 score \<3
• • Estimated survival time ≥3 months
• * Normal organ and marrow function as defined below:
• • Hemoglobin: greater than or equal to 100g/L ;Leukocytes: greater than or equal to 4,000 G/L; Neutrophil: greater than or equal to 2,000 G/L; Platelets: greater than or equal to 100,000/mm3 ; Creatinine: less than or equal to 1.5 times the upper limit or CCR greater than or equal to 60 ml/min; AST/ALT: less than or equal to 2.5 times the upper limit; Total bilirubin: less than or equal to 1.5 times the upper limit; INR: less than or equal to 1.5 times the upper limit; APTT: less than or equal to 1.5 times the upper limit; PT: less than or equal to 1.5 times the upper limit
• • Informed consent
• Exclusion Criteria:
• • With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc
• • Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer
• • Existing active infection such as active tuberculosis and hepatitis
• • History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
• • Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
• • History of allergic reactions attributed to paclitaxel, albumin or cisplatin
• • Participation in other clinical trials currently or within 4 weeks of selection
• • Pregnant or lactating females