Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer

Immunotherapy Clinical Trial

Official title:

A Phase II Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821765
• Other study ID #: NCC2749
• Status: Recruiting
• Phase: Phase 2
• 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
• 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;

Related Conditions & MeSH terms

• Chemoradiotherapy
• Esophageal Neoplasms
• Esophagus Cancer
• Immunotherapy
• Oligometastatic Disease

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