Clinical trial NCT05919030: A Study of Chemoradiation in Combination with Tislelizumab As First Line Treatment in Participants with Advanced Esophageal Squamous Cell Carcinoma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Esophageal Squamous Cell Carcinoma
Keywords: Chemoradiation
Immunotherapy
Advanced esophageal cancer
Low PD-L1 expression
Progression-free survival
Lead sponsor: Renmin Hospital of Wuhan University
Sponsor class: OTHER
First posted: 2023-06-26
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Approximately 40 months from date of the first participant randomization
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Approximately 40 months from date of the first participant randomization
measure: Objective Response Rate (ORR)
timeFrame: Approximately 40 months from date of the first participant randomization
measure: Duration of Response (DOR)
timeFrame: Approximately 40 months from date of the first participant randomization
measure: Number of participants experiencing Adverse Events (AEs)
timeFrame: Approximately 40 months from date of the first participant randomization
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Renmin hosptial of Wuhan University
state: Hubei
Study officials:
References: