Cohort Study of Definitive Chemoradiotherapy for Esophageal or Esophagogastric Junction Cancer

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug, Radiation
Study Type: Interventional
Study Phase: Phase 3
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.

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 4th of Radiation Oncology, Anyang Cancer Hospital
RECRUITING
Anyang
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
Hunan Cancer Hospital, the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
RECRUITING
Changsha
Department of Radiation oncology, Jiangsu Cancer Hospital/Jiangsu Institute of Cancer Research/The affiliated Cancer Hospital of Nanjing Medical University
RECRUITING
Nanjing
Department of Radiation oncology, Jiangsu Province Hospital/The First Affiliated Hospital with Nanjing Medical University
RECRUITING
Nanjing
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
Placebo_comparator: Definitive Chemoradiation
This arm received chemoradiation without immunotherapy/targeting agents as definitive treatment.
Experimental: Chemoradiation Combined With Immunotherapy/targeting agents
This arm received chemoradiation with immunotherapy/targeting agents as definitive treatment.
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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