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NCT04821765CompletedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 30 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
35 (actual)
First submitted
15 Mar 2021
Start date
1 Oct 2020
Primary completion date
30 Jun 2023
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT04821765

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 35
  • From 1 Oct 2020 to the primary completion date, 30 Jun 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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)
  • Active infections, such as active tuberculosis, are present;

Other

  • Pregnancy, possible pregnancy, or breast-feeding;
  • Psychological, family, social and other factors lead to uninformed consent;
  • Any situation that is unstable or may compromise patient safety and compliance ;

Who the study is looking for

  • •≥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;

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Department 4th of Radiation Oncology, Anyang Cancer Hospital
Coordinator of this site? Confirm its status
AnyangChinaUnknown status
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)
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.