Camrelizumab Combined With Radiotherapy for Adjuvant Treatment of Esophageal Squamous Cell Carcinoma After Surgery

  • STATUS
    Recruiting
  • End date
    Aug 13, 2023
  • participants needed
    20
  • sponsor
    Fuzhou General Hospital
Updated on 13 February 2021

Summary

This is an investigator-initiated, single-arm, single-center, exploratory clinical study.The study population consisted of patients with R0 resection of esophageal squamous cell carcinoma who had not received radiation therapy.The purpose of this study was to evaluate the efficacy and safety of carrelizumab combined with radiotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.About 20 subjects are planned to be enrolled in this study.Drug regimen: Patients with esophageal squamous cell carcinoma received radiotherapy combined with carrilizumab adjuvant therapy for 6 cycles 1-3 months after R0 resection.

Details
Condition Esophageal Squamous Cell Carcinomas
Treatment Radiotherapy, Camrelizumab
Clinical Study IdentifierNCT04741490
SponsorFuzhou General Hospital
Last Modified on13 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have any of these conditions: Do you have Esophageal Squamous Cell Carcinomas??
Age 18 - 75 yearmale or female
The clinical stages of esophageal squamous cell carcinoma diagnosed by pathology (including histology or cytology) were T1-4AN0M0 and T1-4AN +M0
Patients who underwent surgical resection and were assessed as R0.However, patients who have received previous radiotherapy should be excluded
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Survival expectation 3 months
The laboratory test value of the patient before medication should meet the following
standards
Routine bloodWBC3.0 109/LANC1.5 109/LPLT90 109/LHGB9.0 g/dL
Liver functionTBIL1.5 ULNAST2.5 ULNALT2.5 ULNSubjects with liver metastasisAST5 ULNALT5 ULN
Renal functionCr1.5 ULN or CrCl 50 mL/min
Blood coagulation functionINR1.5APTT1.5 ULN
Women of childbearing age must have a serum pregnancy study within 2 weeks prior to the first dose and the results are negative. Female subjects of childbearing age and partners who are women of childbearing age must be contraceptive during the study period and within 180 days after the last administration of the study drug

Exclusion Criteria

Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation
Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction
There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia
Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above
Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., grade 1 or level required at baseline, excluding fatigue or hair loss)
Allergic reactions to test drugs for this application
Pregnant or lactating women
Those whom the investigator considered unsuitable for inclusion
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