Back to resultsSalvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy (SINCERE)
Primary Purpose
Esophageal Squamous Cell Carcinomas
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinomas
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Stage II/III carcinoma of the esophagus squamous cell carcinoma.
- Completed pre-operative chemoradiotherapy followed by surgery
- Diagnosed with residual pathologic disease after being surgically rendered free of
- Disease with negative margins following complete resection
- Nonresponding to initial neoadjuvant Chemoradiotherapy(TRG3 and TRG4)
Exclusion Criteria:
- Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
- Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；
- Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction；
- There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia；
- Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above；
- Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss);
- Allergic reactions to test drugs for this application；
- Pregnant or lactating women； Those whom the investigator considered unsuitable for inclusion。
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
experimental arm
Arm Description
PF regimen (cis-platinum of 75mg/m2/d, d1; 5-fluorouracil of 600mg/m2d1-4) combined with PD-1 inhibitors（pembrolizumab，200mg d1） every 3 weeks for 4 cycles followed by PD-1 inhibitors（pembrolizumab，200mg d1）every 3 weeks up to 2 years in a standard manner.
Outcomes
Primary Outcome Measures
Disease-free Survival (DFS)
Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events.
Secondary Outcome Measures
Overall survival (OS)
Overall survival is defined as the time from date of surgery to date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date").
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following surgery
Full Information
NCT ID
NCT05103501
First Posted
October 11, 2021
Last Updated
November 1, 2021
Sponsor
Shanghai Chest Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05103501
Brief Title
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy
Acronym
SINCERE
Official Title
Salvage Immunotherapy Combined With Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy (SINCERE Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2021 (Anticipated)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
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 an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinomas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
PF regimen (cis-platinum of 75mg/m2/d, d1; 5-fluorouracil of 600mg/m2d1-4) combined with PD-1 inhibitors（pembrolizumab，200mg d1） every 3 weeks for 4 cycles followed by PD-1 inhibitors（pembrolizumab，200mg d1）every 3 weeks up to 2 years in a standard manner.
Intervention Type
Drug
Intervention Name(s)
PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）
Intervention Description
immunotherapy:PD-1 inhibitor chemotherapy:5-Fu and DDP
Primary Outcome Measure Information:
Title
Disease-free Survival (DFS)
Description
Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events.
Time Frame
up to approximately 46 months
Secondary Outcome Measure Information:
Title
Overall survival (OS)
Description
Overall survival is defined as the time from date of surgery to date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date").
Time Frame
up to approximately 46 months
Title
Overall Survival Rate
Description
Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following surgery
Time Frame
From date of surgery to 1, 2 and 3 years later
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:
Diagnosed with Stage II/III carcinoma of the esophagus squamous cell carcinoma.
Completed pre-operative chemoradiotherapy followed by surgery
Diagnosed with residual pathologic disease after being surgically rendered free of
Disease with negative margins following complete resection
Nonresponding to initial neoadjuvant Chemoradiotherapy(TRG3 and TRG4)
Exclusion Criteria:
Known or suspected history of active autoimmune diseases, autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, pituitaritis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases or syndromes)
Have a history of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency disease, or history of organ transplantation and bone marrow transplantation；
Interstitial lung disease, drug-induced pneumonia, radiation pneumonitis requiring steroid therapy or active pneumonia with clinical symptoms or severe pulmonary dysfunction；
There are clinical symptoms or diseases of the heart that are not well controlled, such as: (1) heart failure of NYHA class 2 or higher (2) unstable angina (3) myocardial infarction within 24 weeks (4) clinical need for treatment or Interventional supraventricular or ventricular arrhythmia；
Have a tendency to hereditary bleeding or coagulopathy. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood++ and above；
Has not fully recovered from toxicity and/or complications from any intervention prior to initiation of treatment (i.e., ≤ grade 1 or level required at baseline, excluding fatigue or hair loss);
Allergic reactions to test drugs for this application；
Pregnant or lactating women； Those whom the investigator considered unsuitable for inclusion。
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Salvage Immunotherapy and Chemotherapy in Esophageal Squamous Cell Carcinoma Patients Nonresponding to Initial Neoadjuvant Chemoradiotherapy
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