About this trial
Esophageal cancer is the most prevalent cancer globally with poor survival outcome. The prognosis with surgery alone is poor, accounting for 30-40% of overall survival at 5 year. Either neoadjuvant chemotherapy (nCT) or chemoradiotherapy (nCRT) has been shown as efficatious therapy to improve patients outcomes in esophageal or esophagogastric junction cancer as compared with surgery alone. The purpose of this study was to explore the optimal neoadjuvant treatment modalities including PD-1/PD-L1 antibody or targeted drug for patients with 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
Platinum based chemotherapy
Drugq1-3W according to physician's preference
Paclitaxel based chemotherapy
Drugq1-3W according to physician's preference
Radiotherpay
Radiation40-50Gy/1.8-2.2Gy/20-25f
Surgery
Procedure/SurgeryRadical esophagectomy
Immunotherapy
DrugAnti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherpay
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
Secondary outcomes
Progression free survival
Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy
Acute and late toxicities are evaluated by NCI-CTC version 5.0
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 the correlation between radiation dose and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Radiomics analysis
The value of Radiomics of MRI and CT in predicting pathological complete response (pCR) or no response (NR) and the correlation between radiomics of MRI and CT and overall survival (OS), which is defined as the time from the beginning of neoadjuvant chemotherapy to the death with any causes.
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
Click on the lead sponsor to view all of their trials.