Chemoradiotherapy, Esophagus Cancer, Immunotherapy, Oligometastatic Disease
Conditions
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.
Interventions
DRUGPD-1 antibody
200mg, d1, q3W
RADIATIONChemoradiation
50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week
DRUGAlbumin-Bound Paclitaxel
150mg/m2, d1, q3W
DRUGCisplatin
75mg/m2, d1, q3W
Sponsors
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Locoregional control rate | 3 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor response rate | 2-3 months | — |
| Progression free survival | 1 year, 2 year, 3 year | — |
| Number of participants with acute toxicities | 10 week, from the start of treatment to 1 month after chemoradiotherapy | Acute toxicities are evaluated by NCI-CTC version 5.0 |
| Objective response rate | 5.5 week | Objective Response Rate are evaluated by RECIST 1.1 |
| Radiomics analysis | 1 year, 2 year, 3 year, 5 year | Analysis of correlation between radiomics signature extracted by LASSO and the rate of participants who achieve pathological complete response (pCR) and the overall survival based on MRI and CT simulation. |
| Overall survival | 1 year, 2 year, 3 year | — |
Countries
China
Outcome results
None listed