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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

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.

Condition or disease Intervention/treatment Phase
Esophagus Cancer Chemoradiotherapy Oligometastatic Disease Immunotherapy Drug: PD-1 antibody Radiation: Chemoradiation Drug: Albumin-Bound Paclitaxel Drug: Cisplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of PD-1 Antibody Combined With Chemoradiotherapy in Oligometastatic Esophageal Squamous Cell Carcinoma
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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




Primary Outcome Measures :
  1. Locoregional control rate [ Time Frame: 3 year ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821765


Contacts
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Contact: Xin Wang, MD +861013311583220 beryl_wx2000@163.com

Locations
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China, Beijing
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) Recruiting
Beijing, Beijing, China, 100021
Contact: Xin Wang, MD       beryl_wx2000@163.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
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Responsible Party: Wang Xin, Principal Investigator, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT04821765    
Other Study ID Numbers: NCC2749
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antibodies
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs