Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab (SCHRT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Squamous Cell Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Yuan He, doctor; Phone Number: +8618926243766 800-555-5555; Email: heyuan3766@126.com

Study Locations

• China
  • Hefei, China, 230001
    • Recruiting
    • Yuan He
    • Contact: Yuan He; Phone Number: +8618926243766; Email: heyuan3766@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with region-relapsed or progressive esophageal squamous cell carcinoma

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	progression free survival	1 month post treatment]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ORR	objective response rate	1 month post treatment]
1，3-year overall survival, Adverse effect	overall survival, Adverse effect	1 month post treatment]

Collaborators and Investigators

• Sponsor: Anhui Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 20, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: esophageal squamous cell carcinoma; Raltitrexed; tirelesizumab; Short course hypofractionated radiotherapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
• Other Study ID Numbers: 2024-ky117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No