Combining chemoradiation with Tislelizumab for advanced esophageal cancer treatment

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

This study is testing if combining chemoradiation with Tislelizumab can help people with advanced esophageal cancer live longer without their disease getting worse.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Renmin Hospital of Wuhan University (Academic / other)
• Drugs / interventions: Tislelizumab, chemotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT05919030 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, open-label Phase 3 clinical trial investigates the efficacy of chemoradiation combined with Tislelizumab as a first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC) who have low PD-L1 expression. Participants will be randomly assigned to receive either chemoradiation or chemotherapy with Tislelizumab, with the primary goal of improving progression-free survival (PFS). The study focuses on patients who are not candidates for curative treatments and aims to provide insights into the effectiveness of this combination therapy in a specific patient population.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals with unresectable, advanced, recurrent, or metastatic esophageal squamous cell carcinoma and low PD-L1 expression.

Not a fit: Patients with symptomatic brain or spinal cord metastases, active autoimmune diseases, or serious uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment approach could significantly improve progression-free survival for patients with advanced esophageal squamous cell carcinoma.

How similar studies have performed: Other studies have shown promise in combining immunotherapy with chemoradiation for various cancers, suggesting potential success for this approach in esophageal cancer as well.

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.

Where this trial is running

Wuhan, Hubei

• Renmin hosptial of Wuhan University — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Yongshun Chen, MD

Conditions Esophageal Squamous Cell Carcinoma; Chemoradiation; Immunotherapy; Advanced esophageal cancer; Low PD-L1 expression; Progression-free survival