Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab

Last updated: May 20, 2024
Sponsor: Anhui Provincial Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lung Cancer

Squamous Cell Carcinoma

Esophageal Cancer

Treatment

N/A

Clinical Study ID

NCT06408584
2024-ky117
  • Ages > 18
  • All Genders

Study Summary

The goal of this observational study was to explore the safety and efficacy of short course hypofractionated radiotherapy combined with Raltitrexed and Tislelizumab in the treatment of patients with relapsed or advanced esophageal squamous cell carcinoma.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signing informed consent; ECOG 0-2 points;

  • Age over 18 years old, gender is not limited;

  • Esophageal squamous cell carcinoma confirmed by pathology or clinically diagnosed byimaging;

  • Recurrence of the tumor area after radical surgery or radical chemoradiotherapy;Regional progression of advanced esophageal squamous cell carcinoma after first-lineor second-line treatment;

  • Clinical staging: regional recurrence (rT0-4N0-3M0-1a) or regional progression (cT0-4N0-3M0-1) (AJCC/UICC esophageal cancer staging (8th edition));

  • Tumor lesions can be evaluated;

  • Expected survival ≥3 months;

  • Major organ function is normal, meeting the following criteria: (i) blood routineexamination A.HB ≥90g/L; b.ANC≥1.5×109/L; C. PLT ≥80×109/L; (ii) Biochemicalexamination: a. ALT/AST≤2.5ULN; b. TBIL≤1.5ULN; c. Plasma Cr≤1.5ULN or creatinineclearance (CCr)≥60ml/min;

  • Women of childbearing age must have had a pregnancy within 7 days before startingtreatment and the result is negative;

  • All enrolled patients should take adequate contraceptive measures throughout thetreatment period and 4 weeks after completion;

  • no serious hematopoietic function, heart function, endocrine and immune functiondefects;

  • No patients with grade 3 or above other serious medical diseases.

Exclusion

Exclusion Criteria:

  • Under 18 years of age; ECOG is greater than 2;

  • The diagnosis of esophageal cancer is not supported by pathological biopsy or imageexamination;

  • Salvage surgery was performed after tumor recurrence;

  • The patient has any active autoimmune disease (such as the following, but notlimited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis,hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient hadvitiligo; Those with complete remission of asthma in childhood can be includedwithout any intervention in adulthood; Patients with asthma requiring medicalintervention with bronchodilators are not included);

  • Patients who were taking immunosuppressants or systemic hormone therapy forimmunosuppressive purposes (doses >10mg/ day of prednisone or other therapeutichormones) and continued to use within 2 weeks before enrollment;

  • Patients with severe and/or uncontrolled concomitant disease of grade 3 or higher,including: poor blood pressure control, myocardial ischemia or myocardialinfarction, arrhythmia, active or uncontrolled severe infection; Liver diseases suchas decompensated liver disease, active hepatitis B (HBV-DNA≥104 copy numbers /ml or 2000IU/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above thelower detection limit of analytical methods);

  • Pregnant or lactating women;

  • Patients who have a history of psychotropic drug abuse and cannot quit or havemental disorders;

  • Patients who have participated in clinical trials of other drugs within four weeks; .Patients or family members refused to participate in the study.

Study Design

Total Participants: 25
Study Start date:
March 01, 2024
Estimated Completion Date:
March 01, 2027

Connect with a study center

  • Yuan He

    Hefei, 230001
    China

    Active - Recruiting

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