Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Radiotherapy, Platinum based chemotherapy, Paclitaxel based chemotherapy, Immunotherapy.
- Who it may be relevant to
- Registry conditions: Esophagus Cancer, Esophagogastric Junction Cancer, Chemoradiation, Targeted Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
Overview
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.
Interventions
- Radiation Radiotherapy
50-66Gy/1.8-2.2Gy/25-30f - Drug Platinum based chemotherapy
q1-3W according to physician's preference - Drug Paclitaxel based chemotherapy
q1-3W according to physician's preference - Drug Immunotherapy
Anti-PD-1/PD-L1 Antibody - Drug 5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference - Drug Nimotuzumab
200-400mg, d1,qW
Primary outcome measures
- Overall survival [Time frame: 1year]
- Overall survival [Time frame: 2 year]
- Overall survival [Time frame: 3 year]
- Overall survival [Time frame: 5 year]
Secondary outcome measures (6)
- 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 [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]
Eligibility criteria
Inclusion criteria
- ≥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；
- ECOG PS score: 0\~1；
- 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；
Exclusion criteria
- 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；
- Absence of medical records.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 5 centers
- Department 4th of Radiation Oncology, Anyang Cancer Hospital — Anyang
- Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Centr — Changsha
- Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Rese — Nanjing
- Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital — Nanjing
- Department of Radiation Oncology, National Cancer Center/National Clinical Research Center — Beijing
Publications
- Yang X, Wang X, Xiao Q, Ge X, Yu N, Li J, Feng G, Zheng Z, Jiang Y, Lu L, Xia X, Deng L, Zhang T, Wang W, Liu W, Wang J, Xiao Z, Zhou Z, Bi N, Wang H, Chen C, Wang X. Definitive chemoradiotherapy combined with anti-PD-1 immunotherapy for inoperable esophageal squamous cell carcinoma: a multicenter real-world study. Cancer Biol Ther. 2025 Dec;26(1):2504726. doi: 10.1080/15384047.2025.2504726. Epub PMID 40367097
Identifiers
NCT: NCT04821778 · NCC2722