Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab

NCT06408584 | Recruiting DMC

• 1 other identifier: 2024-ky117
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Squamous Cell Carcinoma

Keywords

esophageal squamous cell carcinoma; tirelesizumab; Raltitrexed; Short course hypofractionated radiotherapy

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  1 month post treatment]

Secondary Outcomes (2)

• ORR

  1 month post treatment]

• 1，3-year overall survival, Adverse effect

  1 month post treatment]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with region-relapsed or progressive esophageal squamous cell carcinoma

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead

Study Sites (1)

Yuan He

Hefei, 230001, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Yuan He, doctor

CONTACT

800-555-5555; heyuan3766@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: May 10, 2024
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 21, 2024

Record last verified: 2024-05

Locations

CN (1)