Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Trial Title: Low Dose Decitabine in Combination With Tirelizumab Comparison of Tirelizumab in the First-line Treatment of Advanced Esophageal Squamous Cell Carcinoma

NCT ID: NCT05638984

Condition: PFS

Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Decitabine

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Decitabine Injection
Description: Injection site citabine, 10 mg/ bottle, 10 mg/d, Q3W, D1-D5 intravenous infusion; Tirelizumab injection 200mg D5 intravenous infusion
Arm group label: low-dose decitabine combined with tirelizumab

Other name: tirelizumab

Intervention type: Drug
Intervention name: tirelizumab
Description: 10ml: 100mg / 1 bottle, 200mg, Q3W, D1 i. v. infusion.
Arm group label: low-dose decitabine combined with tirelizumab
Arm group label: tirelizumab

Summary: To evaluate the efficacy and safety of low-dose decitabine combined with tirelizumab in the treatment of patients with advanced esophageal squamous cell carcinoma who did not progress in first-line immunotherapy combined with chemotherapy.

Criteria for eligibility:
Criteria:
Inclusion Criteria: Subjects voluntarily participate and sign written informed consent; Age ≥18 years; Confirmed by histopathology and/or cytology as esophageal squamous cell carcinoma; At least one measurable lesion according to AJCC 8th staging and RECIST 1.1 solid tumor evaluation criteria. Those who have received immunocheckpoint inhibitors combined with chemotherapy (e.g., paclitaxel + cisplatin) in the first line, and the disease has not progressed; Good functioning of major organs, no serious uncontrolled hypertension, diabetes and heart disease, that is, the relevant indicators within 14 days before treatment meet the following requirements: - ANC≥1.2×109/L and lymphocyte count ≥0.5×109/L without the support of granulocyte colony stimulating factor; - Without blood transfusion, patients with platelet count ≥100×109/L and hemoglobin ≥90g/L can meet the criteria through blood transfusion; - AST, ALT and ALP≤2.5× upper limit of normal (ULN), total bile red ≤1.5×ULN, except the following conditions: for known Gilbert patients: total bilirubin ≤3×ULN, creatinine ≤1.5×ULN, albumin ≥25g/L; - For patients not receiving anticoagulant therapy: INR and aPTT≤1.5×ULN. estimated survival ≥3 months; Score of ECOG physical strength: 0~1; The ability of patients to follow the study protocol according to the judgment of the investigator. Exclusion Criteria: Previous immunotherapy; no measurable lesions; There are small cell carcinoma, adenocarcinoma or mixed carcinoma components in the histology; Complete esophageal obstruction; Any NCI CTCAE≥ Grade 2 toxicity that has not recovered after previous chemotherapy; High risk of esophageal fistula was found through clinical evaluation or imaging examination, such as history of esophageal fistula or related symptoms, or primary tumor infiltration into large blood vessels or trachea; had positive detection for EB virus (EBV) capsid antigen IgM during screening (PCR method); If a patient requires analgesic treatment, the treatment regimen used at the time of enrollment must be stable; The men who have HIV positive results at the time of screening; people who test positive for hepatitis C virus (HCV) during sieving; HBV positive screening, and cccDNA≥500 IU/mL; Any of the following diseases in the 12 months prior to enrollment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, or cerebrovascular accident; Pregnant or lactating women or fertile but did not take contraceptive measures; suffer any other serious physical or mental problem of an acute or chronic nature; judging by the researchers, that doesn't fit to participate in the study. -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: January 1, 2023

Completion date: December 31, 2024

Lead sponsor:
Agency: Fudan University
Agency class: Other

Source: Fudan University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05638984