Chemoradiotherapy in Unresectable Esophageal Cancer

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase I/II clinical study is designed to evaluate the 1 year local tumor control rate of chemoradiotherapy using albumin-bound paclitaxel and cisplatin in unresectable esophageal squamous cell carcinomas based on Nutritional Risk Screening NRS2002.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Treatments: Albumin-Bound Paclitaxel; Cisplatin; Paclitaxel

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