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Completed

NCT Number: NCT04821765

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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 Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

PD-1 antibody

Drug

200mg, d1, q3W

Chemoradiation

Radiation

50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week

Albumin-bound paclitaxel

Drug

150mg/m2, d1, q3W

Cisplatin

Drug

75mg/m2, d1, q3W

Primary outcomes

  1. Locoregional control rate

    Time frame: 3 year

Secondary outcomes

  1. Number of participants with acute toxicities

    Time frame: 10 week, from the start of treatment to 1 month after chemoradiotherapy

    Acute toxicities are evaluated by NCI-CTC version 5.0

  2. Tumor response rate

    Time frame: 2-3 months

  3. Progression free survival

    Time frame: 1 year, 2 year, 3 year

  4. Overall survival

    Time frame: 1 year, 2 year, 3 year

  5. Objective response rate

    Time frame: 5.5 week

    Objective Response Rate are evaluated by RECIST 1.1

  6. Radiomics analysis

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Mar 30, 2021
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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