Cohort Study of Neoadjuvant Treatment Modalities for Esophageal Cancer

Who is this study for? Patients with Esophageal Cancer
What treatments are being studied? Radiotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug, Radiation, Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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;

Locations
Other Locations
China
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)
RECRUITING
Beijing
Contact Information
Primary
Xin Wang, MD
beryl_wx2000@163.com
+861013311583220
Time Frame
Start Date: 2002-01-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 2000
Treatments
Experimental: (Neoadjuvant chemotherapy) nCT
This arm received chemotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
Placebo_comparator: (Neoadjuvant Chemoradiation) nCRT
This arm received chemoradiotherapy with or without immunotherapy/targeting agents as neoadjuvant treatment.
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov