Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05919030

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Esophageal Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Renmin hosptial of Wuhan University

Wuhan, Hubei, 430060, China

Location status: Recruiting

Location contact

Liwei Chen

CONTACT

[email protected]

86+15671578311

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensity-modulated radiotherapy (IMRT)

Radiation

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

Tislelizumab

Drug

200 mg IV Q3W

Cisplatin

Drug

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

Nab paclitaxel

Drug

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

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Approximately 40 months from date of the first participant randomization

    PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Approximately 40 months from date of the first participant randomization

    Overall Survival (OS) is defined as the time between the date of randomization and the date of death. For participants without documentation of death, OS will be censored on the last date the subject was known to be alive.

  2. Objective Response Rate (ORR)

    Time frame: Approximately 40 months from date of the first participant randomization

    Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Best overall response (BOR) is defined as the best response designation as determined by BICR, recorded between the date of randomization and the date of objectively documented progression (per RECIST 1.1) or the date of subsequent anti-cancer therapy (including tumor-directed radiotherapy and tumor-directed surgery), whichever occurs first. Partial response is defined as at least a 30% decrease in the sum of diameters of target lesions. Complete response is defined as the disappearance of all target lesions and the reduction of any pathological lymph nodes to <10 mm.

  3. Duration of Response (DOR)

    Time frame: Approximately 40 months from date of the first participant randomization

    DOR is defined as the time from the first determination of an objective response until the first documentation of progression assessed by the investigator per RECIST v1.1 or death, whichever comes first

  4. Number of participants experiencing Adverse Events (AEs)

    Time frame: Approximately 40 months from date of the first participant randomization

    AEs are documented according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4

Study contacts

Contact information is provided by the study sponsor or research team.

Yongshun Chen, MD

CONTACT

[email protected]

+86 15327122084

Sponsors and collaborators

Lead sponsor

Renmin Hospital of Wuhan University

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jun 26, 2023
Registry last updated
Nov 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.