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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,000
50-66Gy/1.8-2.2Gy/25-30f
q1-3W according to physician's preference
q1-3W according to physician's preference
Anti-PD-1/PD-L1 Antibody
W1-5 qW or d1-14, q3W according to physician's preference
200-400mg, d1,qW
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China
RECRUITINGHunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China
RECRUITINGDepartment of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGDepartment of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGDepartment 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
RECRUITINGOverall survival
Time frame: 1year
Overall survival
Time frame: 2 year
Overall survival
Time frame: 3 year
Overall survival
Time frame: 5 year
Progression free survival
Time frame: 1 year, 2 year, 3 year, 5 year
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Time frame: 3 months
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).
Time frame: 3 months
R0 resection rate
Time frame: 3 months
Locoregional recurrence free survival
Time frame: 1 year, 2 year, 3 year, 5 year
Distant metastasis free survival
Time frame: 1 year, 2 year, 3 year, 5 year
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