Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
Overview
- Phase
- Phase 3
- Intervention
- Radiotherapy
- Conditions
- Esophagus Cancer
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Enrollment
- 2000
- Locations
- 5
- Primary Endpoint
- Overall survival
- Status
- Recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
XIN WANG
Principal Investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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.
Arms & Interventions
Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Intervention: Radiotherapy
Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Intervention: Platinum based chemotherapy
Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Intervention: Paclitaxel based chemotherapy
Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Intervention: 5-FU Analog based chemotherapy
Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Intervention: Radiotherapy
Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Intervention: Platinum based chemotherapy
Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Intervention: Paclitaxel based chemotherapy
Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Intervention: Immunotherapy
Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Intervention: 5-FU Analog based chemotherapy
Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Intervention: Nimotuzumab
Outcomes
Primary Outcomes
Overall survival
Time Frame: 5 year
Secondary Outcomes
- Distant metastasis free survival(1 year, 2 year, 3 year, 5 year)
- R0 resection rate(3 months)
- Locoregional recurrence free survival(1 year, 2 year, 3 year, 5 year)
- 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)