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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(Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
Platinum based chemotherapy
q1-3W according to physician's preference
Paclitaxel based chemotherapy
q1-3W according to physician's preference
Radiotherpay
40-50Gy/1.8-2.2Gy/20-25f
Surgery
Radical esophagectomy
Immunotherapy
Anti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherpay
W1-5 qW or d1-14, q3W according to physician's preference
Nimotuzumab
200-400mg, d1,qW
(Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
Platinum based chemotherapy
q1-3W according to physician's preference
Paclitaxel based chemotherapy
q1-3W according to physician's preference
Surgery
Radical esophagectomy
Immunotherapy
Anti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherpay
W1-5 qW or d1-14, q3W according to physician's preference
Nimotuzumab
200-400mg, d1,qW
Interventions
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Platinum based chemotherapy
q1-3W according to physician's preference
Paclitaxel based chemotherapy
q1-3W according to physician's preference
Radiotherpay
40-50Gy/1.8-2.2Gy/20-25f
Surgery
Radical esophagectomy
Immunotherapy
Anti-PD-1/PD-L1 Antibody
5-FU Analog based chemotherpay
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 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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Other Identifiers
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NCC2721
Identifier Type: -
Identifier Source: org_study_id