Clinical trial NCT06408584: Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: esophageal squamous cell carcinoma
tirelesizumab
Raltitrexed
Short course hypofractionated radiotherapy
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2024-05-10
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with region-relapsed or progressive esophageal squamous cell carcinoma

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.


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;
* no serious hematopoietic function, heart function, endocrine and immune function defects;
* No patients with grade 3 or above other serious medical diseases.

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 \&gt;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.

Primary outcomes:
measure: PFS
timeFrame: 1 month post treatment]
Secondary outcomes:
measure: ORR
timeFrame: 1 month post treatment]
measure: 1，3-year overall survival, Adverse effect
timeFrame: 1 month post treatment]
Other outcomes:
Locations:
city: Hefei
country: China
facility: Yuan He
Study officials:
References: