Chemoradiotherapy in Esophageal or Esophagogastric Junction Cancer
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Definitive Chemoradiation This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment. |
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: 5-FU Analog based chemotherapy
W1-5 qW or d1-14, q3W according to physician's preference
|
| Experimental: Chemoradiation Combined With Immunotherapy/targeting agents This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment. |
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
|
Outcome Measures
Primary Outcome Measures
- Overall survival [1year]
- Overall survival [2 year]
- Overall survival [3 year]
- 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]
- 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 correlation between radiomics signature extracted by LASSO 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]
Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
≥18 years；
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Esophageal or Esophagogastric cancer；
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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 4th of Radiation Oncology, Anyang Cancer Hospital | Anyang | Henan | China | |
| 2 | Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University | Nanjing | Jiangsu | China | |
| 3 | 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 | |
| 4 | Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University | Changsha | China | ||
| 5 | Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University | Nanjing | China |
Sponsors and Collaborators
- Chinese Academy of Medical Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCC2722