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Neoadjuvant Immunotherapy Combined With Chemotherapy in Patients With Locally Advanced ESCC

Primary Purpose

Esophagus Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Paclitaxel-albumin
Carboplatin
Sponsored by
Shanghai Zhongshan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophagus Cancer

Eligibility Criteria

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

Inclusion Criteria: Age 18-75 years ; Initially diagnosed patients with stage T2-4aN0-1M0 esophageal squamous cell carcinoma; No chemotherapy or any other antitumor therapy was used before inclusion ECOG score 0-1; Life expectancy is greater than 3 months; The patient has no indication for emergency surgery; No immediate childbearing requirement; The main organs function well, and the examination indicators meet the following requirements: i. Blood routine examination: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil count ≥1.5×109/L; Platelet count ≥75×109/L; ii. Biochemical examination: iii. Total bilirubin ≤1.5×ULN (upper limit of normal); iv. Serum alanine aminotransferase (ALT) or serum alanine oxalacetic aminotransferase (AST) ≤ 2.5×ULN; v. Endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Sign informed consent; The compliance was good, and the family members agreed to cooperate with the survival follow-up. Exclusion Criteria: Pregnant or nursing women; Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical carcinoma in situ; Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as determined by the investigator, may prevent the signing of informed consent or affect the patient's adherence to medication use; Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; Allergic to any investigational drug ingredient; Any bleeding event with a severe grade of 3 or above CTCAE4.0 occurring within 4 weeks prior to screening; Patients with hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg) who are not well controlled by single antihypertensive medication;History of unstable angina pectoris;Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening;Arrhythmias (including QTcF: male ≥450 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency; Long-term unhealed wounds or incomplete healing fractures; Previous history of organ transplantation; Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment; Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L) and bleeding tendency (14 days before randomization must meet the requirement that INR is within the normal range without the use of anticoagulants);Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogities;Low doses of warfarin (1 mg orally, once daily) or low doses of aspirin (up to 100 mg daily) are permitted for prophylactic purposes if INR ≤ 1.5; Occurrence of arteriovenous thrombosis within one year prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and determined to be cured by researchers), pulmonary embolism, etc.; Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study. Patients who did not meet the inclusion criteria, or who were considered unsuitable for the study by the investigator.

Sites / Locations

  • ShanghaiZhongshanRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tislelizumab combined with chemotherapy

Arm Description

Outcomes

Primary Outcome Measures

Pathological complete response
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell

Secondary Outcome Measures

Major pathological response
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Objective Response Rate (ORR)
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor

Full Information

First Posted
March 27, 2023
Last Updated
April 8, 2023
Sponsor
Shanghai Zhongshan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05807542
Brief Title
Neoadjuvant Immunotherapy Combined With Chemotherapy in Patients With Locally Advanced ESCC
Official Title
Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma (ESCC) : A Single-Arm Phase II Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Zhongshan Hospital

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Prediction for pCR After Neoadjuvant Immunotherapy Combined With Chemotherapy Using Single-Cell RNA Sequencing in Patients With Locally Advanced Esophageal Squamous Cell Carcinoma

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophagus 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
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tislelizumab combined with chemotherapy
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Tislelizumab will be administered on day 1 of each cycle at 200mg once every 21 days.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel-albumin
Intervention Description
Paclitaxel-albumin will be administered on day 1 of each cycle at 260mg/m2 once every 21 days.
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
carboplatin will be administered on day 1 of each cycle at AUC=5 once every 21 days.
Primary Outcome Measure Information:
Title
Pathological complete response
Description
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time Frame
4 weeks after surgery
Secondary Outcome Measure Information:
Title
Major pathological response
Description
Total/moderate tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Time Frame
4 weeks after surgery
Title
Objective Response Rate (ORR)
Description
Objective Response Rate Determine the tumor shrinkage rate, tumor boundary and the adhesion of tumor
Time Frame
At the end of Cycle 3 (each cycle is 21 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18-75 years ; Initially diagnosed patients with stage T2-4aN0-1M0 esophageal squamous cell carcinoma; No chemotherapy or any other antitumor therapy was used before inclusion ECOG score 0-1; Life expectancy is greater than 3 months; The patient has no indication for emergency surgery; No immediate childbearing requirement; The main organs function well, and the examination indicators meet the following requirements: i. Blood routine examination: Hemoglobin ≥90 g/L (no blood transfusion within 14 days); Neutrophil count ≥1.5×109/L; Platelet count ≥75×109/L; ii. Biochemical examination: iii. Total bilirubin ≤1.5×ULN (upper limit of normal); iv. Serum alanine aminotransferase (ALT) or serum alanine oxalacetic aminotransferase (AST) ≤ 2.5×ULN; v. Endogenous creatinine clearance ≥ 50 ml/min (Cockcroft-Gault formula); Sign informed consent; The compliance was good, and the family members agreed to cooperate with the survival follow-up. Exclusion Criteria: Pregnant or nursing women; Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical carcinoma in situ; Patients with a history of uncontrolled epilepsy, central nervous system disease or mental disorder whose clinical severity, as determined by the investigator, may prevent the signing of informed consent or affect the patient's adherence to medication use; Severe uncontrolled recurrent infections, or other severe uncontrolled concomitant diseases; Allergic to any investigational drug ingredient; Any bleeding event with a severe grade of 3 or above CTCAE4.0 occurring within 4 weeks prior to screening; Patients with hypertension (systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg) who are not well controlled by single antihypertensive medication;History of unstable angina pectoris;Patients with newly diagnosed angina pectoris or myocardial infarction within 3 months prior to screening;Arrhythmias (including QTcF: male ≥450 ms) requiring long-term use of antiarrhythmic drugs and New York Heart Association grade ≥II cardiac insufficiency; Long-term unhealed wounds or incomplete healing fractures; Previous history of organ transplantation; Imaging shows that the tumor has invaded important blood vessels, or the investigator determines that the patient's tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during treatment; Patients with abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg<2g/L) and bleeding tendency (14 days before randomization must meet the requirement that INR is within the normal range without the use of anticoagulants);Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin, or their analogities;Low doses of warfarin (1 mg orally, once daily) or low doses of aspirin (up to 100 mg daily) are permitted for prophylactic purposes if INR ≤ 1.5; Occurrence of arteriovenous thrombosis within one year prior to screening, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis (except venous thrombosis caused by intravenous catheterization during previous chemotherapy and determined to be cured by researchers), pulmonary embolism, etc.; Those who have a history of psychotropic substance abuse and cannot abstain or have mental disorders; A history of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; In the investigator's judgment, there is a serious concomitant disease that endangers the patient's safety or interferes with the patient's completion of the study. Patients who did not meet the inclusion criteria, or who were considered unsuitable for the study by the investigator.
Facility Information:
Facility Name
ShanghaiZhongshan
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fan hong, doctor
Phone
13916897139
Ext
86
Email
fan.hong@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Neoadjuvant Immunotherapy Combined With Chemotherapy in Patients With Locally Advanced ESCC

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