Status:
COMPLETED
Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer
Lead Sponsor:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Esophagus Cancer
Chemoradiotherapy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Chemoradiotherapy（CRT） is the main treatment for esophageal cancer patients with recurrent desease，and checkpoint blockade (PD-1) have been shown to be effective in advanced esophageal cancer. Therefo...
Eligibility Criteria
Inclusion
- •≥18 years；
- Esophageal squamous cell carcinomas；
- After radical treatment including surgery or definitive chemoradiotherapy
- Definition of oligometastases：≤3 metastases, including tumor beds and recurrent anastomotic sites；regional lymph node is defined as one metastatic site（AJCC8th, supraclavicular, mediastinal, abdominal）；metastases lesion in liver, lung, bone and brain is no more than 1.
- Karnofsky performance status(KPS)≥ 70；
- No immunotherapy were performed after recurrence；
- a white-cell count of at least 3500G/L, a hemoglobin concentration of at least 100 g/L, a platelet count of at least 100,000/lL, aspartate aminotransferase and alanine aminotransferase levels of within 1.5 times the upper limit of normal, a serum bilirubin level of 1.5 mg/dL or less, a creatinine level of 1.1 mg/dL or less;
- Hepatitis virus indicators: normal or hepatitis virus DNA titer less than 500 at the same time in an infectious disease hospital, and with the consent of the doctor can be treated；
Exclusion
- Pregnancy, possible pregnancy, or breast-feeding;
- Psychological, family, social and other factors lead to uninformed consent;
- An esophageal mediastinal fistula and/or an esophageal tracheal fistula prior to treatment;
- Serious complications such as ischemic heart disease, arrhythmias, or other types of heart disease requiring treatment; liver cirrhosis; interstitial pneumonia or pulmonary fibrosis; active gastrointestinal bleeding; mental disorders being treated with antipsychoticagents or requiring treatment;
- Controlled diabetes mellitus;
- A history of autoimmune disease, autoimmune disease (such as colitis, hepatitis, hyperthyroidism, including but not limited to these disease or syndrome) and a history of immune deficiency, including test positive for HIV, or has other acquired, congenital immunodeficiency disease, or have a history of organ transplantation and the history of allogeneic bone marrow transplantation;
- A history of interstitial lung disease and a history of non-infectious pneumonia;
- Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 Copies /mL), hepatitis C ;(positive HCV antibody and HCV-RNA above the detection threshold of the assay）
- Any situation that is unstable or may compromise patient safety and compliance ;
- Active infections, such as active tuberculosis, are present;
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04821765
Start Date
October 1 2020
End Date
December 31 2024
Last Update
May 30 2025
Active Locations (2)
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1
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, Beijing Municipality, China, 100021
2
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Anyang, Henan, China, 455001