Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab in Patients With Region-relapsed or Progressive Esophageal Squamous Cell Carcinoma: a Single Arm, Observational Study

Anhui Provincial Hospital1 site in 1 country25 target enrollmentMarch 1, 2024

ConditionsEsophageal Squamous Cell Carcinoma

Overview

Phase: N/A
Intervention: Not specified
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Anhui Provincial Hospital
Enrollment: 25
Locations: 1
Primary Endpoint: PFS
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

March 1, 2027

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Anhui Provincial Hospital

Responsible Party

Sponsor

Eligibility Criteria

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 by imaging;
•Recurrence of the tumor area after radical surgery or radical chemoradiotherapy; Regional progression of advanced esophageal squamous cell carcinoma after first-line or 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 routine examination A.HB ≥90g/L; b.ANC≥1.5×109/L; C. PLT ≥80×109/L; (ii) Biochemical examination: a. ALT/AST≤2.5ULN; b. TBIL≤1.5ULN; c. Plasma Cr≤1.5ULN or creatinine clearance (CCr)≥60ml/min;
•Women of childbearing age must have had a pregnancy within 7 days before starting treatment and the result is negative;
•All enrolled patients should take adequate contraceptive measures throughout the treatment period and 4 weeks after completion;

Exclusion Criteria

•Under 18 years of age; ECOG is greater than 2;
•The diagnosis of esophageal cancer is not supported by pathological biopsy or image examination;
•Salvage surgery was performed after tumor recurrence;
•The patient has any active autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; The patient had vitiligo; Those with complete remission of asthma in childhood can be included without any intervention in adulthood; Patients with asthma requiring medical intervention with bronchodilators are not included);
•Patients who were taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes (doses \>10mg/ day of prednisone or other therapeutic hormones) 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 myocardial infarction, arrhythmia, active or uncontrolled severe infection; Liver diseases such as 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 the lower detection limit of analytical methods);
•Pregnant or lactating women;
•Patients who have a history of psychotropic drug abuse and cannot quit or have mental disorders;
•Patients who have participated in clinical trials of other drugs within four weeks; .Patients or family members refused to participate in the study.