Combining short-course radiotherapy with Raltitrexed and Tislelizumab for advanced esophageal cancer

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

This study is testing a new treatment that combines short radiation therapy with two medications to see if it helps people with advanced esophageal cancer that has come back or gotten worse.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Anhui Provincial Hospital (Government)
• Drugs / interventions: prednisone, Tislelizumab
• Locations: 1 site (Hefei)
• Trial ID: NCT06408584 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the safety and efficacy of a treatment regimen that includes short-course hypofractionated radiotherapy combined with Raltitrexed and Tislelizumab for patients suffering from relapsed or advanced esophageal squamous cell carcinoma. The study focuses on patients who have experienced tumor recurrence after previous treatments or have regional progression of the disease. Participants will be monitored for their response to this combination therapy, assessing both safety and effectiveness in managing their condition.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with confirmed esophageal squamous cell carcinoma who have experienced tumor recurrence or progression after prior treatments.

Not a fit: Patients with early-stage esophageal cancer or those who have not undergone prior treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that improves outcomes for patients with advanced esophageal squamous cell carcinoma.

How similar studies have performed: While this specific combination has not been extensively tested, similar approaches using radiotherapy and immunotherapy have shown promise in other studies.

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 \>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.

Where this trial is running

Hefei

• Yuan He — Hefei, China (Recruiting)

Study contacts

• Study coordinator: Yuan He, doctor

Conditions Esophageal Squamous Cell Carcinoma; esophageal squamous cell carcinoma; tirelesizumab; Raltitrexed; Short course hypofractionated radiotherapy