Chemoradiotherapy in Unresectable Esophageal Cancer
Recruiting now · Phase 1/Phase 2
Conditions studied: Esophageal Cancer, Chemoradiotherapy, Albumin-bound Paxlitaxel, Unresectable Malignant Neoplasm
In brief
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.
Key facts
- Study ID
- NCT04278287
- Run by
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- People needed
- 105
- Starts
- 2019-10-01
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2024-12-13
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Department 4th of Radiation Oncology, Anyang Cancer Hospital — Anyang, Henan, China (enrolling)
- Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China (enrolling)
- Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (enrolling)
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC) — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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