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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04821765
Other study ID # NCC2749
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date October 1, 2020
Est. completion date September 30, 2023

Study information

Verified date March 2021
Source Chinese Academy of Medical Sciences
Contact Xin Wang, MD
Phone +861013311583220
Email beryl_wx2000@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date September 30, 2023
Est. primary completion date September 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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;

Study Design


Intervention

Drug:
PD-1 antibody
200mg, d1, q3W
Radiation:
Chemoradiation
50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week
Drug:
Albumin-Bound Paclitaxel
150mg/m2, d1, q3W
Cisplatin
75mg/m2, d1, q3W

Locations

Country Name City State
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) Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Locoregional control rate 3 year
Secondary Number of participants with acute toxicities Acute toxicities are evaluated by NCI-CTC version 5.0 10 week, from the start of treatment to 1 month after chemoradiotherapy
Secondary Tumor response rate 2-3 months
Secondary Progression free survival 1 year, 2 year, 3 year
Secondary Overall survival 1 year, 2 year, 3 year
Secondary Objective response rate Objective Response Rate are evaluated by RECIST 1.1 5.5 week
Secondary Radiomics analysis 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. 1 year, 2 year, 3 year, 5 year
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