Clinical trial NCT04821765: Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer
Official title: A Phase II Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Esophagus Cancer
Chemoradiotherapy
Oligometastatic Disease
Immunotherapy
Lead sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. Therefore, PD-1 combined with chemoradiotherapy （CRT）may further improve the efficacy and become a new method for the treatment of esophageal cancer.This study intends to conduct a single-arm, prospective clinical study, aiming to evaluate the safety and efficacy of PD-1 combined with chemoradiotherapy(CRT) in patients with oligometastatic esophageal squamous cell carcinoma.


Eligibility criteria: Inclusion Criteria:

•≥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 Criteria:

* 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;

Primary outcomes:
measure: Locoregional control rate
timeFrame: 3 year
Secondary outcomes:
measure: Number of participants with acute toxicities
timeFrame: 10 week, from the start of treatment to 1 month after chemoradiotherapy
measure: Tumor response rate
timeFrame: 2-3 months
measure: Progression free survival
timeFrame: 1 year, 2 year, 3 year
measure: Overall survival
timeFrame: 1 year, 2 year, 3 year
measure: Objective response rate
timeFrame: 5.5 week
measure: Radiomics analysis
timeFrame: 1 year, 2 year, 3 year, 5 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: 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)
state: Beijing
city: Anyang
country: China
facility: Department 4th of Radiation Oncology, Anyang Cancer Hospital
state: Henan
Study officials:
References: