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Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
Affiliated Cancer Hospital of Shantou University Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring esophageal squamous cell carcinoma, immunotherapy, chemotherapy, surgery, adjuvant therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Aged between 18 and 70 years Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes (T1-3N1-3M0) undergoing radical esophagectomy ECOG (Eastern Cooperative Oncology Group) : 0-1 No recurrent disease before adjuvant therapy Normal hemodynamic indices before the recruitment Able to understand this study and have signed informed consent Exclusion Criteria: previous or concurrent malignancy Interstitial lung disease Requiring systemic treatment with either corticosteroids or other immunosuppressive medications Known or suspected allergy to chemotherapeutic drugs or Tislelizumab Active autoimmune disease Active hepatitis Those whom the investigator considered unsuitable for inclusion

Sites / Locations

  • Cancer Hospital of Shantou University Medical CollegeRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adjuvant Chemotherapy in Combination With Immunotherapy

Arm Description

Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery

Outcomes

Primary Outcome Measures

disease-free survival rate
disease free survival after surgery

Secondary Outcome Measures

Rate of adverse events
Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)

Full Information

First Posted
August 2, 2023
Last Updated
August 2, 2023
Sponsor
Affiliated Cancer Hospital of Shantou University Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05984342
Brief Title
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Official Title
Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2023 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Cancer Hospital of Shantou University Medical College

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
Esophageal cancer is one of the most common malignancies in China, and esophageal squamous cell carcinoma (ESCC) is the predominant histological type. Surgical resection is still a standard therapeutic approach for patients with resectable ESCC, but the prognosis is still disappointing. Although neoadjuvant chemoradiotherapy plus surgery is currently recommended for patients with locally advanced ESCC, it is still an infrequently used procedure in China. The efficacy of adjuvant therapy on ESCC is still controversial. Recently, the CheckMate 577 trial showed that adjuvant nivolumab therapy could improve DFS for patients with residual disease after neoadjuvant chemoradiotherapy plus surgery. However, no optimal postoperative adjuvant therapy was recommended for patients with ESCC received upfront surgery. We designed a prospective randomized controlled tial to study whether immunotherapy could be used with chemotherapy after surgery to improve overall survival in these patients. The primary endpoint of the study is disease free survival, with secondary endpoints of overall survival, safety and toxicity, and quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma
Keywords
esophageal squamous cell carcinoma, immunotherapy, chemotherapy, surgery, adjuvant therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adjuvant Chemotherapy in Combination With Immunotherapy
Arm Type
Experimental
Arm Description
Adjuvant Chemotherapy in Combination With Tislelizumab was used in patients with Lymph Node-Positive Esophageal Squamous Cell Carcinoma after surgery
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
nab-paclitaxel, Cisplatin
Intervention Description
Adjuvant Chemotherapy (nab-paclitaxel 260mg/m2 d1 plus Cisplatin 75mg/m2 d1 or 25mg/m2 d1-3) in combination with Tislelizumab (200 mg Q3W)
Primary Outcome Measure Information:
Title
disease-free survival rate
Description
disease free survival after surgery
Time Frame
1 years after surgery
Secondary Outcome Measure Information:
Title
Rate of adverse events
Description
Rate of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI- CTCAE v5.0)
Time Frame
within 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged between 18 and 70 years Untreated before surgery (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy) Histologically documented squamous cell carcinoma of the thoracic esophagus with positive lymph nodes (T1-3N1-3M0) undergoing radical esophagectomy ECOG (Eastern Cooperative Oncology Group) : 0-1 No recurrent disease before adjuvant therapy Normal hemodynamic indices before the recruitment Able to understand this study and have signed informed consent Exclusion Criteria: previous or concurrent malignancy Interstitial lung disease Requiring systemic treatment with either corticosteroids or other immunosuppressive medications Known or suspected allergy to chemotherapeutic drugs or Tislelizumab Active autoimmune disease Active hepatitis Those whom the investigator considered unsuitable for inclusion
Facility Information:
Facility Name
Cancer Hospital of Shantou University Medical College
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shao-bin Chen
Phone
+8613417000759
Email
chensb535176@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Adjuvant Chemotherapy in Combination With Tislelizumab in Lymph Node-Positive Esophageal Squamous Cell Carcinoma

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