Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
NCT ID: NCT04821778
Last Updated: 2024-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
2000 participants
INTERVENTIONAL
2002-01-01
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Radiotherapy
50-66Gy/1.8-2.2Gy/25-30f
Platinum based chemotherapy
q1-3W according to physician's preference
Paclitaxel based chemotherapy
q1-3W according to physician's preference
5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference
Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Radiotherapy
50-66Gy/1.8-2.2Gy/25-30f
Platinum based chemotherapy
q1-3W according to physician's preference
Paclitaxel based chemotherapy
q1-3W according to physician's preference
Immunotherapy
Anti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference
Nimotuzumab
200-400mg, d1,qW
Interventions
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Radiotherapy
50-66Gy/1.8-2.2Gy/25-30f
Platinum based chemotherapy
q1-3W according to physician's preference
Paclitaxel based chemotherapy
q1-3W according to physician's preference
Immunotherapy
Anti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference
Nimotuzumab
200-400mg, d1,qW
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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XIN WANG
Principal Investigator
Locations
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Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
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
Countries
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Central Contacts
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Facility Contacts
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Yidian Zhao
Role: primary
Xiaomin Wang, MD
Role: backup
Qin Xiao, MD
Role: primary
Cheng Chen, MD
Role: primary
Xiaolin Ge, MD
Role: primary
Xinchen Sun
Role: backup
Xin Wang, MD
Role: primary
References
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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 2025 May 14.
Other Identifiers
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NCC2722
Identifier Type: -
Identifier Source: org_study_id