Back to resultsTislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC
Primary Purpose
Esophageal Squamous Cell Carcinoma, Locally Advanced Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
5-FU
cis Platinum
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Drug: Tislelizumab, Chemotherapy
Eligibility Criteria
Inclusion Criteria:
- Aged between 18 and 75 years;
- Understand the research procedure and content, and voluntarily sign written informed consent;
- Patients with clinical stage IIA-IIIB esophageal cancer were assessed by endoscopic ultrasonography, CT/MRI and other imaging.
- Esophageal surgery experts believe that patients with potentially resectable esophageal cancer
- No blood transfusion was received 3 months before enrollment;
- ECOG PS score: 0-1.
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible for inclusion:
- Women who are pregnant or breastfeeding;
- previous or concurrent malignancy;
- Participated in clinical trials of other drugs within four weeks;
- Have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc.
- Patients with hypersensitivity to human or mouse monoclonal antibodies;
- Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
- According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.
Sites / Locations
- Jiangsu Provincial People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tislelizumab plus Chemotherapy
Arm Description
In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .
Outcomes
Primary Outcome Measures
Incidence of translational treatment AE
Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned
MPR
The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy
pCR
Pathological complete response refers to that no tumor component or a small amount of carcinoma in situ component can be found on the horizontal line of pathological section after systemic treatment and surgical resection of the lesion.
Secondary Outcome Measures
R0 resection rate
The proportion of patients who completed R0 resection through 3 cycles of immunotherapy combined with chemotherapy in the total enrolled population.R0 finger resection margin under microscope was negative.
Disease-free Survival，DFS
The time from randomization to disease recurrence or death due to disease progression
Full Information
NCT ID
NCT05469061
First Posted
June 8, 2022
Last Updated
July 19, 2022
Sponsor
The First Affiliated Hospital with Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05469061
Brief Title
Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC
Official Title
The Safety and Efficacy of Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC，A Single-arm Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a single-arm，open-label study to evaluate the efficacy and safety of tislelizumab plus chemotherapy for conversion therapy of patients with locally nonresectable ESCC.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Locally Advanced Carcinoma
Keywords
Drug: Tislelizumab, Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tislelizumab plus Chemotherapy
Arm Type
Experimental
Arm Description
In the single experimental arm, patients with locally nonresectable disease were subjected to receive neoadjuvant tislelizumab (200mg) plus chemotherapy (FP regimen) for conversion therapy. If conversion therapy succeeds, patients would proceed to surgery and adjuvant therapy. Otherwise, if patients were still not resectable after the conversion therapy, they will be treated by tislelizumab plus chemotherapy with or without palliative radiotherapy .
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
The 1st to 3rd doses were administered concurrently with FP regimen chemotherapy, 200 mg Tislelizumab each, on D1, D22 and D43 by intravenous infusion. In patients with successful conversion, one dose of 200 mg was administered 21 days after surgery in concurrent with the 4th to 6th cycles of 5-Fu, then 6 cycles of 200 mg Tislelizumab as adjuvant therapy; in patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
Intervention Type
Drug
Intervention Name(s)
5-FU
Intervention Description
A FP regimen with 5-Fu 850mg/m^2 d1-4 + cis-platinum 850mg/m^2 d1-4 was used, on D1, D22 and D43 infused intravenously. 3 cycles of 5-Fu 850mg/m^2 d1-4 adjuvant chemotherapy were started at 21 days after surgery in patients with a successful conversion. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
Intervention Type
Drug
Intervention Name(s)
cis Platinum
Intervention Description
A FP regimen with 5-Fu 850mg/m^2 d1-4 + cis-platinum 850mg/m^2 d1-4 was used, on D1, D22 and D43 infused intravenously. In patients with failed conversion, chemotherapy combined with tislelizumab were administered, with or without radiation therapy.
Primary Outcome Measure Information:
Title
Incidence of translational treatment AE
Description
Translational treatment-related AEs resulted in rates of surgery that were more than 30 days late or inoperable than originally planned
Time Frame
up to 2 years
Title
MPR
Description
The proportion of patients whose primary tumor cell residual was less than 10% in the total number of patients enrolled after transformation therapy
Time Frame
up to 2 years
Title
pCR
Description
Pathological complete response refers to that no tumor component or a small amount of carcinoma in situ component can be found on the horizontal line of pathological section after systemic treatment and surgical resection of the lesion.
Time Frame
up to 2 years
Secondary Outcome Measure Information:
Title
R0 resection rate
Description
The proportion of patients who completed R0 resection through 3 cycles of immunotherapy combined with chemotherapy in the total enrolled population.R0 finger resection margin under microscope was negative.
Time Frame
up to 2 years
Title
Disease-free Survival，DFS
Description
The time from randomization to disease recurrence or death due to disease progression
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Aged between 18 and 75 years;
Understand the research procedure and content, and voluntarily sign written informed consent;
Patients with clinical stage IIA-IIIB esophageal cancer were assessed by endoscopic ultrasonography, CT/MRI and other imaging.
Esophageal surgery experts believe that patients with potentially resectable esophageal cancer
No blood transfusion was received 3 months before enrollment;
ECOG PS score: 0-1.
Exclusion Criteria:
Patients meeting any of the following criteria are not eligible for inclusion:
Women who are pregnant or breastfeeding;
previous or concurrent malignancy;
Participated in clinical trials of other drugs within four weeks;
Have a history of immune deficiency, or other acquired or congenital immune deficiency diseases, or have a history of organ transplantation, or have a history of serious chronic autoimmune diseases, such as systemic lupus erythematosus, etc.
Patients with hypersensitivity to human or mouse monoclonal antibodies;
Those who have a history of psychotropic drug abuse and cannot get rid of it or have mental disorders;
According to the judgment of the researcher, there are serious concomitant diseases that endanger the patient's safety or affect the patient's ability to complete the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tongpeng Xu, PhD
Phone
18915594572
Email
tongpeng_xu_njmu@163.com
Facility Information:
Facility Name
Jiangsu Provincial People's Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongpeng Xu, PhD
Phone
18915594572
Email
tongpeng_xu_njmu@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Tislelizumab in Combination With Chemotherapy for Conversion Therapy of Locally Nonresectable ESCC
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