About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Radiotherapy
  • Albumin-Bound Paclitaxel
  • Cisplatin

Treatment groups

105 Participants
are divided into 1 treatment group

Locations

5
Department 4th of Radiation Oncology, Anyang Cancer Hospital455001, AnyangHenan, China
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University410031, ChangshaHunan, China
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University210009, NanjingJiangsu, China
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University210029, NanjingJiangsu, China

Sponsors and collaborators

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor