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

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ClinicalTrials.gov Identifier: NCT04821765
Recruitment Status : Recruiting
First Posted : March 30, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Wang Xin, Chinese Academy of Medical Sciences

Tracking Information
First Submitted Date  ICMJE March 15, 2021
First Posted Date  ICMJE March 30, 2021
Last Update Posted Date March 30, 2021
Actual Study Start Date  ICMJE October 1, 2020
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
Locoregional control rate [ Time Frame: 3 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2021)
  • 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
  • Tumor response rate [ Time Frame: 2-3 months ]
  • Progression free survival [ Time Frame: 1 year, 2 year, 3 year ]
  • Overall survival [ Time Frame: 1 year, 2 year, 3 year ]
  • Objective response rate [ Time Frame: 5.5 week ]
    Objective Response Rate are evaluated by RECIST 1.1
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Cancer
Official Title  ICMJE A Phase II Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Squamous Cell Carcinoma
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Esophagus Cancer
  • Chemoradiotherapy
  • Oligometastatic Disease
  • Immunotherapy
Intervention  ICMJE
  • 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
  • Drug: Cisplatin
    75mg/m2, d1, q3W
Study Arms  ICMJE Experimental: Chemoradiotherapy Combined With PD-1 Antibody
The arm received chemoradiotherapy, 50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week) to recurrent sites combined with chemotherapy(Cisplatin 75 mg/m2/day 1, and albumin paclitaxel 150 mg/m2/day 1 , every 3 weeks, 2 cycles ).PD-1 antibody (Tislelizumab) was performed simultaneously with concurrent chemoradiotherapy (Triprizumab 200mg,d1,every 3 weeks,2 cycles). After completion of chemoradiotherapy, PD-1 antibody was given continuously with 2-4 cycles of chemotherapy (the same regimen with concurrent chemotherapy) until 1 year or desease progression.
Interventions:
  • Drug: PD-1 antibody
  • Radiation: Chemoradiation
  • Drug: Albumin-Bound Paclitaxel
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 26, 2021)
35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xin Wang, MD +861013311583220 beryl_wx2000@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04821765
Other Study ID Numbers  ICMJE NCC2749
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Wang Xin, Chinese Academy of Medical Sciences
Study Sponsor  ICMJE Chinese Academy of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Chinese Academy of Medical Sciences
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP