NCT06408584 Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab
| NCT ID | NCT06408584 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Anhui Provincial Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2024-03-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \>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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06408584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06408584 currently recruiting?
Yes, NCT06408584 is actively recruiting participants. Contact the research team at heyuan3766@126.com for enrollment information.
Where is the NCT06408584 trial being conducted?
This trial is being conducted at Hefei, China.
Who is sponsoring the NCT06408584 clinical trial?
NCT06408584 is sponsored by Anhui Provincial Hospital. The trial plans to enroll 25 participants.