NCT05919030RecruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 14 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 155 (estimated)
- First submitted
- 16 Jun 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Renmin Hospital of Wuhan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05919030
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 155
- From 1 Jul 2023 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Other
- Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Renmin hosptial of Wuhan University Coordinator of this site? Confirm its status | Wuhan | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.