Neoadjuvant Treatment Modalities in Esophageal Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: (Neoadjuvant chemotherapy) nCT This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. |
Drug: Platinum based chemotherapy
q1-3W according to physician's preference
Drug: Paclitaxel based chemotherapy
q1-3W according to physician's preference
Radiation: Radiotherpay
40-50Gy/1.8-2.2Gy/20-25f
Procedure: Surgery
Radical esophagectomy
Drug: Immunotherapy
Anti-PD-1/PD-L1 Antibody
Drug: 5-FU Analog based chemotherpay
W1-5 qW or d1-14, q3W according to physician's preference
Drug: Nimotuzumab
200-400mg, d1,qW
|
| Placebo Comparator: (Neoadjuvant Chemoradiation) nCRT This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment. |
Drug: Platinum based chemotherapy
q1-3W according to physician's preference
Drug: Paclitaxel based chemotherapy
q1-3W according to physician's preference
Procedure: Surgery
Radical esophagectomy
Drug: Immunotherapy
Anti-PD-1/PD-L1 Antibody
Drug: 5-FU Analog based chemotherpay
W1-5 qW or d1-14, q3W according to physician's preference
Drug: Nimotuzumab
200-400mg, d1,qW
|
Outcome Measures
Primary Outcome Measures
- Overall survival [5 year]
Secondary Outcome Measures
- Progression free survival [1 year, 2 year, 3 year, 5 year]
- Number of participants with Acute and late toxicities of radiotherapy,chemotherapy and immunotherapy [3 months]
Acute and late toxicities are evaluated by NCI-CTC version 5.0
- Pathological response rate [3 months]
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 [3 months]
- Locoregional recurrence free survival [1 year, 2 year, 3 year, 5 year]
- Distant metastasis free survival [1 year, 2 year, 3 year, 5 year]
Other Outcome Measures
- Analysis of the correlation between radiation dose and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0. [1 year, 2 year, 3 year, 5 year]
- Radiomics analysis [1 year, 2 year, 3 year, 5 year]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥18 years；
-
Esophageal or Esophagogastric cancer；
-
Histologically proven squamous cell carcinoma or adenocarcinoma in patients staged as I-IVa (AJCC 8th)；
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Primary treatment performed in Cancer Hospital, Chinese Academy of Medical Sciences；
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ECOG PS score: 0~1；
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Estimated survival time ≥3 months；
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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；
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Informed consent；
Exclusion Criteria:
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With any distant metastasis out of regional lymphatic drainage or in liver, lung, bone, CNS, etc；
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Patients with other cancer history in 5 years except cervical carcinoma in situ and non-malignant melanoma skin cancer；
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Existing active infection such as active tuberculosis and hepatitis；
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History of myocardial infarction within the past 6 months or history of ventricular arrhythmia；
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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；
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Participation in other clinical trials currently or within 4 weeks of selection；
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Pregnant or lactating females；
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Absence of medical records.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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 | 100021 |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCC2721