A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intensity-modulated radiotherapy (IMRT), Tislelizumab, Cisplatin, Nab paclitaxel.
- Who it may be relevant to
- Registry conditions: Esophageal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- 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
Primary outcome measures
- Progression-Free Survival (PFS) [Time frame: Approximately 40 months from date of the first participant randomization]
Secondary outcome measures (4)
- Overall Survival (OS) [Time frame: Approximately 40 months from date of the first participant randomization]
- Objective Response Rate (ORR) [Time frame: Approximately 40 months from date of the first participant randomization]
- Duration of Response (DOR) [Time frame: Approximately 40 months from date of the first participant randomization]
- Number of participants experiencing Adverse Events (AEs) [Time frame: Approximately 40 months from date of the first participant randomization]
Eligibility criteria
Inclusion criteria
- Subjects must have histologically confirmed squamous cell carcinoma of esophagus (per AJCC 8th edition).
- Subjects must have unresectable advanced, recurrent or metastatic ESCC.
- Subjects must not be amenable to curative approaches such as definitive chemoradiation and/or surgery.
- PD-L1 expression (CPS) is less than 10.
- No prior systemic anticancer therapy given as primary therapy for advanced or metastatic disease.
- ECOG Performance Status of 0 or 1.
- 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.
- Subjects must have adequate organ and bone marrow function.
Exclusion criteria
- Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.
- Active known or suspected autoimmune disease.
- Any serious or uncontrolled medical disorder or active infection.
- Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Renmin hosptial of Wuhan University — Wuhan
Identifiers
NCT: NCT05919030 · WDRY2023-K088