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

A Low Dose Decitabine Combined With Tirelizumab Prospective Phase II Clinical Study Comparing Tirelizumab in Patients With Advanced Esophageal Squamous Cell Carcinoma Who Did Not Progress With First-line Immunotherapy Combined With Chemotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: PFS
• Intervention / Treatment: Drug: Decitabine Injection; Drug: tirelizumab

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: low-dose decitabine combined with tirelizumab; Injection site citabine, 10 mg/ bottle, 10 mg/d, Q3W, D1-D5 intravenous infusion; Tirelizumab injection 200mg D5 intravenous infusion.	Drug: Decitabine Injection; Injection site citabine, 10 mg/ bottle, 10 mg/d, Q3W, D1-D5 intravenous infusion; Tirelizumab injection 200mg D5 intravenous infusion; Other Names: tirelizumab; Drug: tirelizumab; 10ml: 100mg / 1 bottle, 200mg, Q3W, D1 i. v. infusion.
Active Comparator: tirelizumab; Tirelizumab injection, 10ml: 100mg/1 bottle, 200mg, Q3W, D1 IV infusion.	Drug: tirelizumab; 10ml: 100mg / 1 bottle, 200mg, Q3W, D1 i. v. infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	Progression-Free Survival	At the end of last Cycle (each cycle is 21 days)

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: November 16, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: BGB-A317-IIT-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No