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

NCT ID: NCT05919030

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 155 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2027-07-01

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.

Conditions

Esophageal Squamous Cell Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Intensity-modulated radiotherapy (IMRT)

Intervention Type: RADIATION

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

Tislelizumab

Intervention Type: DRUG

200 mg IV Q3W

Cisplatin

Intervention Type: DRUG

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

Nab paclitaxel

Intervention Type: DRUG

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

Chemotherapy + Tislelizumab

Drug: Tislelizumab 200 mg IV Q3W Drug: Nab Paclitaxel 220 mg/m² IV Q3W Drug: Cisplatin 75 mg/m² IV Q3W

Group Type: ACTIVE_COMPARATOR

Tislelizumab

Intervention Type: DRUG

200 mg IV Q3W

Cisplatin

Intervention Type: DRUG

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

Nab paclitaxel

Intervention Type: DRUG

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

Interventions

Intensity-modulated radiotherapy (IMRT)

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

Intervention Type: RADIATION

Tislelizumab

200 mg IV Q3W

Intervention Type: DRUG

Cisplatin

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

Intervention Type: DRUG

Nab paclitaxel

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Renmin Hospital of Wuhan University

OTHER

Sponsor Role: lead

Responsible Party

Yongshun Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Renmin hosptial of Wuhan University

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongshun Chen, MD

Role: CONTACT

yongshun2007@163.com

+86 15327122084

Facility Contacts

Liwei Chen

Role: primary

wdrmiit@163.com

86+15671578311

Other Identifiers

WDRY2023-K088

Identifier Type: -

Identifier Source: org_study_id