A Study of Camrelizumab As Consolidation Therapy After Radical Concurrent Chemoradiotherapy In Locally Advanced ESCC

Last updated: December 8, 2021
Sponsor: Hebei Medical University Fourth Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT04286958
HRHB-CE001
  • Ages 18-75
  • All Genders

Study Summary

The purpose of this study is to assess efficacy and safety of patients who receive camrelizumab as consolidation therapy after radical concurrent chemoradiotherapy in locally advanced ESCC.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age:18 to 75 years old;
  2. Histology confirmed as esophageal squamous cell carcinoma;
  3. T1bN+M0, T2-4N0-2M0 local progress period;
  4. Have previously received radical concurrent chemoradiotherapy;
  5. According to RECIST 1.1, at least one measurable lesion;
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
  7. Expected survival period ≥ 12 weeks;
  8. Major organ function has to meet the following certeria:

1)For results of blood routine test HB≥90g/L; ANC≥1.5×109/L; PLT≥80×109/L; 2)For results ofblood biochemical test ALB≥30g/L; ALT and AST<2.5×ULN; TBIL≤1.5ULN; Serum creatinine ≤1.5ULN; 9. Left ventricular ejection fraction (LVEF) ≥50%; 10. Women of childbearing agemust have contraceptive measures or have test pregnancy (serum or urine) enroll the studybefore 14 days, and the results must be negative, and take the methods of contraceptionduring the test and the last to have drugs after 8 weeks. Men must be contraception or hassterilization surgery during the test and the last to have drugs after 8 weeks; 11.Participants were willing to join in this study, and written informed consent, goodadherence, cooperate with the follow-up.

Exclusion

Exclusion Criteria:

  1. Subjects with immunosuppressive medications within 14 days of first administration ofstudy treatment, excluding nasal spray and inhaled corticosteroids or physiologicaldoses of systemic steroid hormones (no more than 10 mg / day of prednisolone or othercorticosteroids of equivalent pharmaceutical physiological dose);
  2. The patient has any active autoimmune disease or a history of autoimmune disease (suchas the following, but not limited to: autoimmune hepatitis, interstitial pneumonia,uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis,Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved inchildhood, and patients who do not need any intervention after adulthood can beincluded; asthma patients who require bronchodilators for medical intervention cannotbe included);
  3. Patients with other malignant tumors within 5 years (except for the treated skin basalcell carcinoma and cervical carcinoma in situ);
  4. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis Cantibody, and HCV-RNA is higher than the lower limit of detection of the analyticalmethod) or co-infection with hepatitis B and C, requiring antiviral treatment duringthe study ; 5.6 months before study drug administration, the following occurred:myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiacinsufficiency according to New York Heart Association(NYHA) criteria, uncontrolledarrhythmias (including QTcF interval male> 450 ms, female> 470 ms ,The QTcF intervalis calculated using Fridericia formula), symptomatic congestive heart failure,cerebrovascular accidents (including transient ischemic attack or symptomaticpulmonary embolism);

6.Severe infections within 4 weeks before study drug administration (eg. Need intravenousdrip antibiotics, antifungals or antivirals) or Unexplained fever>38.5℃ during screeningvisits or on the first scheduled day of dosing; 7.History of allogeneic organtransplantation or allogeneic hematopoietic stem cell transplantation; 8.Less than 4 weeksfrom the last clinical trial; 9.History of psychiatric drugs abuse and can't quit orpatients with mental disorders; 10.The researchers think inappropriate.

Study Design

Total Participants: 40
Study Start date:
April 22, 2020
Estimated Completion Date:
March 01, 2023

Study Description

In this study, 40 patients with locally advanced ESCC will be enrolled. All patients who had received radical concurrent chemoradiotherapy were treated with camrelizumab.

Connect with a study center

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei
    China

    Active - Recruiting

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