Neoadjuvant treatments for esophageal cancer
Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer
This study is testing different combinations of treatments for people with esophageal cancer to see if they can improve outcomes compared to just having surgery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Beijing) |
| Trial ID | NCT04821843 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates various neoadjuvant treatment modalities for patients with esophageal or esophagogastric junction cancer, including chemotherapy, chemoradiotherapy, and targeted therapies. The study aims to determine the most effective combination of treatments to improve patient outcomes compared to surgery alone. Participants will receive treatments such as platinum-based chemotherapy, paclitaxel-based chemotherapy, radiotherapy, and immunotherapy. The trial focuses on patients with histologically confirmed squamous cell carcinoma or adenocarcinoma staged I-IVa.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically proven esophageal or esophagogastric junction cancer.
Not a fit: Patients with advanced stages of cancer beyond IVa or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates and quality of life for patients with esophageal cancer.
How similar studies have performed: Previous studies have shown promising results with neoadjuvant therapies in esophageal cancer, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Beijing
- 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 (Recruiting)
Study contacts
- Study coordinator: Xin Wang, MD
- Email: beryl_wx2000@163.com
- Phone: +861013311583220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.