About this trial
Definitive chemoradiotherapy is the standard of care in unresectable esophageal or esophagogastric cancer. A multidisciplinary approach, including chemotherapy and radiotherapy, is important for these patients. Morerover, molecular targeting agents does not show clear efficacy in EC up to now. Nowadays, the pace of development of cancer immunotherapies is accelerating. Clinical evidence of the efficacy of immune checkpoint inhibitors and adoptive immunotherapies herald the onset of a new era in cancer immunotherapy. There have also been recent developments to provide a promising frontier in extending the use of immunotherpay or targeting agents to radiotherapy. The purpose of this study was to explore the optimal treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with unresectable esophageal or esophagogastric junction cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years;
Esophageal or Esophagogastric cancer;
Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa(AJCC 8th);
Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences;
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
Parallel
Treatments tested in this trial
Radiotherapy
Radiation50-66Gy/1.8-2.2Gy/25-30f
Platinum based chemotherapy
Drugq1-3W according to physician's preference
Paclitaxel based chemotherapy
Drugq1-3W according to physician's preference
Immunotherapy
DrugAnti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherapy
DrugW1-5 qW or d1-14, q3W according to physician's preference
Nimotuzumab
Drug200-400mg, d1,qW
Treatment groups
Trial outcomes
Primary outcomes
Overall survival
Overall survival
Overall survival
Overall survival
Secondary outcomes
Progression free survival
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Pathological response rate
Pathological response were classified into three grades.Grade I signifies that there is little shrinkage in the tumor; only mild regression in the tumor cells is observed under themicroscope. Grade II shows gross reduction in size of the tumor and marked regression in the cancer cells microscopically, yet viable nests of cancer tissue are still visible. Grade III implies complete or almost total resolution of the tumor on exploration, and disappearance of the tumor tissue microscopically; only remnants of degenerated cancer cells can be seen (so-called ghost cancer cells).
R0 resection rate
Other outcomes
Analysis of correlation between radiomics signature extracted by LASSO and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Radiomics analysis
Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation.
Target dealineation of organs at risk and their impact on the prognosis and adverse effects of radiotherapy
Target dealineation of clinical target volumn and their impact on the prognosis
Sponsors and contacts
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