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Chemoradiotherapy in Unresectable Esophageal Cancer

RECRUITINGPhase 1/2Sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Actively Recruiting
PhasePhase 1/2
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
Started2019-10-01
Est. completion2025-12
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04278287

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.

Eligibility

Age: 18 Years – 75 YearsHealthy volunteers accepted
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

Conditions5

Albumin-bound PaxlitaxelCancerChemoradiotherapyEsophageal CancerUnresectable Malignant Neoplasm

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