Neoadjuvant Treatment Modalities in Esophageal Cancer
Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
2,000 participants
Jan 1, 2002
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- ≥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 Criteria8
- 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.
Interventions
q1-3W according to physician's preference
q1-3W according to physician's preference
40-50Gy/1.8-2.2Gy/20-25f
Radical esophagectomy
Anti-PD-1/PD-L1 Antibody
W1-5 qW or d1-14, q3W according to physician's preference
200-400mg, d1,qW
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04821843