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

November 12, 2024 updated by: Yongshun Chen, Renmin Hospital of Wuhan University

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

155

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430060
        • Recruiting
        • Renmin hosptial of Wuhan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chemoradiation + Tislelizumab

Intensity-modulated radiotherapy (IMRT):

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

During concurrent radiation therapy:

Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 75 mg/m² IV QW Drug: Cisplatin 25 mg/m² IV QW

During consolidation therapy:

Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 220 mg/m² IV Q3W Drug: Cisplatin 75 mg/m² IV Q3W
Drug: Tislelizumab
200 mg IV Q3W
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: 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
Active Comparator: Chemotherapy + Tislelizumab
Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 220 mg/m² IV Q3W Drug: Cisplatin 75 mg/m² IV Q3W
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 40 months from date of the first participant randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Approximately 40 months from date of the first participant randomization
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.
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
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.
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
AEs are documented according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v4
Approximately 40 months from date of the first participant randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Renmin Hospital of Wuhan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 16, 2023

First Posted (Actual)

June 26, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WDRY2023-K088

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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