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RECRUITINGPhase 3INTERVENTIONAL

A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma

Chemoradiation Versus Chemotherapy in Combination with Tislelizumab As First Line Treatment for Advanced Esophageal Squamous Cell Carcinoma with Low PD-L1 Expression (RENMIN-236): Multicentre, Randomised, Phase 3 Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study is a multicentre, randomised, parallel-controlled, open-label, 3 phase clinical trial. The subjects were untreated, unresectable locally advanced, recurrent or metastatic esophageal squamous cell carcinoma with low PD-L1 expression. Patients were randomly assigned to receive chemoradiation or chemotherapy in combination with Tislelizumab at a ratio of 1: 1. The primary endpoint was progression-free survival (PFS) in the intention-to-treat population. We hypothesized that in advanced esophageal squamous cell carcinoma patients with low PD-L1 expression, chemoradiation versus chemotherapy in combination with Tislelizumab will significantly improve PFS.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Subjects must have diagnosed by tissue sample (biopsy-confirmed) squamous cell carcinoma of esophagus (per AJCC 8th edition). 2. Subjects must have unresectable advanced, recurrent or metastatic ESCC. 3. Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery. 4. PD-L1 expression (CPS) is less than 10. 5. No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease. 6. You should be able to carry out daily activities with 0 level of ability (ECOG 0) or 1. 7. Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment must be performed within 28 days prior to randomization. 8. Subjects must have adequate organ and bone marrow function. Who Should NOT Join This Trial: 1. Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment. 2. Active known or suspected autoimmune conditions (where your immune system attacks your own body). 3. Any serious or uncontrolled medical disorder or active infection. 4. Known history of positive test for human weakened immune system virus (HIV) or known acquired weakened immune system syndrome (AIDS). 5. Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus. 6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Subjects must have histologically confirmed squamous cell carcinoma of esophagus (per AJCC 8th edition). 2. Subjects must have unresectable advanced, recurrent or metastatic ESCC. 3. Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery. 4. PD-L1 expression (CPS) is less than 10. 5. No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease. 6. ECOG Performance Status of 0 or 1. 7. Subjects must have at least one measurable lesion by CT or MRI per RECIST 1.1 criteria; radiographic tumor assessment must be performed within 28 days prior to randomization. 8. Subjects must have adequate organ and bone marrow function. Exclusion Criteria: 1. Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment. 2. Active known or suspected autoimmune disease. 3. Any serious or uncontrolled medical disorder or active infection. 4. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 5. Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus. 6. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.

Treatments Being Tested

RADIATION

Intensity-modulated radiotherapy (IMRT)

Esophageal primary tumor: 39.6Gy/2.2Gy Bone metastasis: 30Gy/3Gy Lung, liver, brain metastases, metastatic lymph nodes: 45Gy/3Gy

DRUG

Tislelizumab

200 mg IV Q3W

DRUG

Cisplatin

During concurrent radiation therapy: 25 mg/m² IV QW During consolidation therapy: 75 mg/m² IV Q3W

DRUG

Nab paclitaxel

During concurrent radiation therapy: 75 mg/m² IV QW During consolidation therapy: 220 mg/m² IV Q3W

Locations (1)

Renmin hosptial of Wuhan University
Wuhan, Hubei, China