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Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.

Primary Purpose

Advanced Esophageal Squamous Cell Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy

About this trial

This is an interventional treatment trial for Advanced Esophageal Squamous Cell Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 18-75
Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0)
Eastern Cooperative Oncology Group (ECOG) status 0-1
Signed written informed consent prior to the implementation of any trial-related rocedures
Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/l Hemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) > 5 x ULN Bilirubin > 1.5 х ULN

Exclusion Criteria:

Patients diagnosed with any other malignant tumor
Patients at risk for tracheoesophageal fistula or aortoesophageal fistula
Have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor
Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding
Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment
Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
A history of interstitial lung disease or non-infectious pneumonia
Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years
Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections
Patients who have received allogeneic stem cell or solid organ transplantation
Women during pregnancy or lactation

Sites / Locations

Shandong Cancer Hospital and InstituteRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab arm

Arm Description

Radiotherapy: PTV 41.4Gy in 23 Fractions，5 days per week; Chemotherapy: Paclitaxel (Albumin bound) (100mg/m2) and Cisplatin (75 mg/m2) for 5 weeks, concurrent with radiotherapy; Immunotherapy: Tislelizumab (200mg per 3 weeks)

Outcomes

Primary Outcome Measures

Major Pathological Response Rate

No more than 10% of tumor cells were found in neoadjuvant surgical specimens.

Pathologic complete response rate

Secondary Outcome Measures

Disease free survival

Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.

Incidence of Treatment-related Adverse Events

Number and percentage of cases of all adverse events

Full Information

NCT ID

NCT05323890

First Posted

April 5, 2022

Last Updated

March 11, 2023

Sponsor

Shandong Cancer Hospital and Institute

1. Study Identification

Unique Protocol Identification Number

NCT05323890

Brief Title

Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.

Official Title

Neoadjuvant Tislelizumab Combined With Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma : Single Arm Phase II Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2022 (Actual)

Primary Completion Date

October 20, 2023 (Anticipated)

Study Completion Date

October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong Cancer Hospital and Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This study aimed to evaluate the safety and feasibility of neoadjuvant tislelizumab combined with chemoradiotherapy in patients with resectable esophageal squamous cell cancer. The tumor microenvironment and circulating immunological biomarkers in these patients were further evaluated to explore the factors affecting the efficacy of neoadjuvant therapy for esophageal cancer. This study will provide valuable information for further prospective clinical trials of neoadjuvant anti-PD-1 and other immunotherapy in esophageal cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Advanced Esophageal Squamous Cell Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Tislelizumab arm

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy

Other Intervention Name(s)

Anti-PD-1 Therapy

Intervention Description

Patients received tislelizumab at a fixed dose of 200 mg every three weeks (q3w, 21 days) for 2 cycles.

Primary Outcome Measure Information:

Title

Major Pathological Response Rate

Description

No more than 10% of tumor cells were found in neoadjuvant surgical specimens.

Time Frame

From date of surgery to 14 days later

Title

Pathologic complete response rate

Description

Pathologic complete response rate

Time Frame

From date of surgery to 14 days later

Secondary Outcome Measure Information:

Title

Disease free survival

Description

Disease free survival will be calculated from the start of the treatment to the disease progression or death of any reason.

Time Frame

24 months

Title

Incidence of Treatment-related Adverse Events

Description

Number and percentage of cases of all adverse events

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 18-75 Histologically or cytologically confirmed resectable squamous-cell esophageal cancer ( cT1-2N+/ cT3-4aN0-3M0) Eastern Cooperative Oncology Group (ECOG) status 0-1 Signed written informed consent prior to the implementation of any trial-related rocedures Adequate organ function, evidenced by laboratory results with no contraindications to chemotherapy Absolute neutrophil count ≥ 1,500 х109/l Thrombocytes ≥ 100 х 109/l Hemoglobin ≥ 90 mg/l Creatinine ≤ 1.5 x ULN or creatinine clearance (calculated using the Cockcroft-Gault formula) ≥40 mL/min Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN) Alkaline phosphatase (ALP) > 5 x ULN Bilirubin > 1.5 х ULN Exclusion Criteria: Patients diagnosed with any other malignant tumor Patients at risk for tracheoesophageal fistula or aortoesophageal fistula Have received prior therapy with: chemotherapy, radiation therapy,immune checkpoint inhibitor Insufficient caloric and/or fluid intake despite consultation with a dietitian and/or tube feeding Have an active infection requiring systemic therapy that has not resolved 3 days (simple infection, such as cystitis) to 7 days (severe infection, such as pyelonephritis) before the first dose of trial treatment Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction A history of interstitial lung disease or non-infectious pneumonia Active autoimmune disease with systemic therapy (ie, use of disease modifiers, corticosteroids, or immunosuppressive drugs) in the past 2 years Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1/2 antibody) and various viral hepatitis infections Patients who have received allogeneic stem cell or solid organ transplantation Women during pregnancy or lactation

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xue Meng, Ph.D, M.D

Phone

17653115602

mengxuesdzl@163.com

Facility Information:

Facility Name

Shandong Cancer Hospital and Institute

City

Jinan

State/Province

Shandong

ZIP/Postal Code

250117

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Meng Xue, Ph.D, M.D

Phone

17653115602

mengxuesdzl@163.com

12. IPD Sharing Statement

Learn more about this trial

Tislelizumab Combined With Neoadjuvant Radiotherapy and Chemotherapy for Resectable Esophageal Squamous Cell Carcinoma.

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