Chemoradiotherapy for esophageal and esophagogastric junction cancer
Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer
PHASE3 · Cancer Institute and Hospital, Chinese Academy of Medical Sciences · NCT04821778
This study is testing a new combination of chemotherapy, radiation, and immune therapies to see if it helps people with advanced esophageal or esophagogastric junction cancer live longer and feel better.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 5 sites (Anyang, Henan and 4 other locations) |
| Trial ID | NCT04821778 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of definitive chemoradiotherapy combined with immunotherapy and targeted therapies for patients with unresectable esophageal or esophagogastric junction cancer. The study employs a multidisciplinary approach, utilizing chemotherapy, radiotherapy, and novel immunotherapeutic agents to enhance treatment outcomes. It aims to identify optimal treatment modalities that may improve survival rates and quality of life for affected patients. The trial includes patients with histologically confirmed squamous cell carcinoma or adenocarcinoma staged I-IVa.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with unresectable esophageal or esophagogastric junction cancer who meet specific health criteria.
Not a fit: Patients with resectable tumors or those with significant comorbidities that affect treatment tolerance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for patients with advanced esophageal or esophagogastric junction cancer.
How similar studies have performed: Other studies have shown promise in using immunotherapy in conjunction with traditional cancer treatments, suggesting potential success for 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
Anyang, Henan and 4 other locations
- Department 4th of Radiation Oncology, Anyang Cancer Hospital — Anyang, Henan, China (RECRUITING)
- Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University — Changsha, Hunan, China (RECRUITING)
- Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
- Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University — Nanjing, Jiangsu, China (RECRUITING)
- 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.
Conditions: Esophagus Cancer, Esophagogastric Junction Cancer, Chemoradiation, Targeted Therapy, Immunotherapy, Chemotherapy Effect