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NCT06408584Recruiting

Short-course Hypofractionated Radiotherapy in Combination With Raltitrexed and Tislelizumab

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

Source: ClinicalTrials.gov · Last updated 21 May 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
25 (estimated)
First submitted
7 Mar 2024
Start date
1 Mar 2024
Primary completion date
1 Mar 2027
Lead sponsor
Anhui Provincial Hospital
NCT number
NCT06408584

What you commit to

  • Study type: Observational
  • Planned participants: 25
  • From 1 Mar 2024 to the primary completion date, 1 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Salvage surgery was performed after tumor recurrence;
  • 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);
  • Patients who have participated in clinical trials of other drugs within four weeks; .Patients or family members refused to participate in the study.

Other illness

  • The diagnosis of esophageal cancer is not supported by pathological biopsy or image examination;
  • 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 have a history of psychotropic drug abuse and cannot quit or have mental disorders;

Age

  • Under 18 years of age; ECOG is greater than 2;

Other

  • Pregnant or lactating women;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Yuan He
Coordinator of this site? Confirm its status
HefeiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.