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Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma by AJCC V8 Stage, Unresectable

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

tislelizumab+ Paclitaxel + Cisplatin

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma by AJCC V8 Stage

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Histologically confirmed esophageal squamous cell carcinoma;
Unresectable cT4a/N3(stage ⅣA) (AJCC 8 TNM classification);
Have a performance status of 0 or 1 on the ECOG Performance Scale;
Age 18-75 years old, both men and women;
Be willing and able to provide written informed consent/assent for the trial;
Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation;
Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the study medication's first dose. If the urine test is positive or cannot be confirmed as unfavorable, a serum pregnancy test will be required;
Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly acquired is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor.

Exclusion Criteria:

Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer;
Ineligibility or contraindication for esophagectomy;
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug;
Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs);
Has severe hypersensitivity and adverse events (≥Grade 3) to any PD-1/PD-L1 inhibitors.

Sites / Locations

Hongjing JiangRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

tislelizumab+ Paclitaxel+Cisplatin

Arm Description

Paclitaxel 135mg/m2 , D1; Cisplatin 80mg/m2, D1; tislelizumab 200mg D2 ; totally 2-4 cycles

Outcomes

Primary Outcome Measures

R0 Surgical Resection Rate .

R0 resection rate

Secondary Outcome Measures

Evaluate the rate of pathologic complete response (pCR) to the study regimen

The percentage of pathologic complete response at resection for patients who has completed the study regimen

Evaluate the rate of main pathologic response (MPR) to the study regimen.

Viable tumor comprised ≤ 10% of resected tumor specimens

Objective response rate (ORR)

Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions

Disease-free survival (DFS)

DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer

Overall survival (OS)

Time from the enrollment to death of any cause

Full Information

NCT ID

NCT05449483

First Posted

July 4, 2022

Last Updated

July 7, 2022

Sponsor

Tianjin Medical University Cancer Institute and Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05449483

Brief Title

Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma

Official Title

A Prospective, Single-center, Single-arm Phase II Clinical Study of the Safety and Efficacy of Tislelizumab Combined With Chemotherapy in the Treatment of Unresectable Esophageal Squamous Cell Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

May 11, 2022 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Tianjin Medical University Cancer Institute and Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Whether the introduction of immunotherapy can transform unresectable esophageal cancer into resectable, or even achieve R0 surgical resection, has not been reported yet. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of unresectable esophageal squamous cell carcinoma.

Detailed Description

For patients not eligible for R0 resection (defined as locally advanced unresectable esophageal cancer), preoperative treatment can theoretically transform the tumor into a resectable state. The current significance of transformation therapy is to reduce tumor volume and stage to achieve radical resection, eliminate micrometastases, and prevent a postoperative recurrence. There are few studies on the transformation therapy of esophageal squamous cell carcinoma. We plan to conduct a prospective, single-center, single-arm phase II clinical study of the safety and efficacy of tislelizumab combined with chemotherapy in the treatment of T4a/N3 esophageal squamous cell carcinoma.

6. Conditions and Keywords

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

Esophageal Squamous Cell Carcinoma by AJCC V8 Stage, Unresectable

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tislelizumab+ Paclitaxel+Cisplatin

Arm Type

Experimental

Arm Description

Paclitaxel 135mg/m2 , D1; Cisplatin 80mg/m2, D1; tislelizumab 200mg D2 ; totally 2-4 cycles

Intervention Type

Drug

Intervention Name(s)

tislelizumab+ Paclitaxel + Cisplatin

Other Intervention Name(s)

conversion therapy

Intervention Description

tislelizumab combined with chemotherapy

Primary Outcome Measure Information:

Title

R0 Surgical Resection Rate .

Description

R0 resection rate

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Evaluate the rate of pathologic complete response (pCR) to the study regimen

Description

The percentage of pathologic complete response at resection for patients who has completed the study regimen

Time Frame

1 year

Title

Evaluate the rate of main pathologic response (MPR) to the study regimen.

Description

Viable tumor comprised ≤ 10% of resected tumor specimens

Time Frame

1 year

Title

Objective response rate (ORR)

Description

Partial response is defined as a decrease by 30% or more in sums of longest diameter of measurable target lesions

Time Frame

1 year

Title

Disease-free survival (DFS)

Description

DFS is defined as the time interval between the date of enrollment and the date of the first documented evidence of relapse after radical resection at any site or death related to cancer

Time Frame

3 years

Title

Overall survival (OS)

Description

Time from the enrollment to death of any cause

Time Frame

3 years

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: Histologically confirmed esophageal squamous cell carcinoma; Unresectable cT4a/N3(stage ⅣA) (AJCC 8 TNM classification); Have a performance status of 0 or 1 on the ECOG Performance Scale; Age 18-75 years old, both men and women; Be willing and able to provide written informed consent/assent for the trial; Demonstrate adequate organ function, all screening labs should be performed within 10 days of treatment initiation; Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the study medication's first dose. If the urine test is positive or cannot be confirmed as unfavorable, a serum pregnancy test will be required; Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly acquired is defined as a specimen obtained up to 4 weeks (28 days) prior to initiation of treatment on Day 1. Subjects for whom newly-obtained samples cannot be provided (e.g. inaccessible or subject safety concern) may submit an archived specimen only upon agreement from the Sponsor. Exclusion Criteria: Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer; Ineligibility or contraindication for esophagectomy; Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug; Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs); Has severe hypersensitivity and adverse events (≥Grade 3) to any PD-1/PD-L1 inhibitors.

Central Contact Person:

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

Hongjing Jiang, MD，phD

Phone

18622221069

jianghongjing@tmu.edu.cn

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

Xiaobin Shang, MD，phD

Phone

18622221071

shangxiaobin@tmu.edu.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hongjing Jiang, MD，phD

Organizational Affiliation

Tianjin Medical University Cancer Institute and Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hongjing Jiang

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hongjing Jiang, MD,PhD

Phone

18622221069

jianghongjing@tmu.edu.cn

First Name & Middle Initial & Last Name & Degree

xiaobin shang, MD,PhD

Phone

18622221071

shangxiaobin@tmu.edu.cn

First Name & Middle Initial & Last Name & Degree

Hongjing Jiang, MD,PhD

First Name & Middle Initial & Last Name & Degree

Xiaobin Shang, MD,PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Conversion of Tislelizumab Combined With Chemotherapy in Unresectable Esophageal Squamous Cell Carcinoma

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