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出境医 / 临床实验 / A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

Study Description
Brief Summary:
The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer.

Condition or disease Intervention/treatment Phase
Esophageal Squamous Cell Carcinoma Biological: Sintilimab Drug: carboplatin/paclitaxel Radiation: Radiation Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : May 1, 2021
Estimated Study Completion Date : May 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: arm

Biological: Sintilimab For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1

Drug: Paclitaxel 50 mg/m^2 IV Q3W day 1, day 8 and day 15

Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15

Radiotherapy:

1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy

 Biological: Sintilimab
Other Name: (IBI308)

Drug: carboplatin/paclitaxel
carboplatin AUC 2/paclitaxel 50 mg/m2 weekly

Radiation: Radiation
IMRT or VMAT
Outcome Measures
Primary Outcome Measures :
  1. unacceptable toxicity [ Time Frame: 1 year ]
    "Unacceptable toxicity" is defined as any of the following toxicities: >1 episode of grade 3/4 neutropenia or thrombocytopenia <75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in >2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of >8 weeks in surgery, i.e. surgery >16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which leads to death within 30 days of surgery

  2. pathologic complete response rate, pCR [ Time Frame: 1 year ]
  3. major pahological response, MPR [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed esophageal squamous carcinoma
  • 18≤age≤75
  • ECOG PS is 0-1
  • TanyN+M0 or T3-4NanyM0 tumors
  • Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
  • No prior chemotherapy,radiotherapy and immunotherapy
  • Disease must be clinically limited to the esophagus
  • No esophageal perforation and no active esophageal bleeding
  • No interstitial pneumonia or history of interstitial pneumonia
  • FEV1>1.2L
  • Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Frediricia's Correction
  • Able to provide written informed consent
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion Criteria:

  • Previous treatment with chemotherapy, radiotherapy or immunotherapy
  • Cervical esophageal cancer
  • Esophageal perforation or active esophageal bleeding
  • Interstitial pneumonia or history of interstitial pneumonia
  • Patients with evidence of metastatic disease
  • Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible
  • Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)
  • 14 days before the first dose, the patient had an active infection that required systemic treatment
  • Inability to understand or may not comply with test requirements
Contacts and Locations

Contacts
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Contact: ji yongling, MD 08613958085251 jiyl@zjcc.org.cn

Locations
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China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310022
Contact: Ming Chen, M.D.    0086-571-88122068    chenming@zjcc.org.cn   
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
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Principal Investigator: chen ming, MD Zhejiang Cancer Hospital
Principal Investigator: chen qixun, MD Zhejiang Cancer Hospital
Tracking Information
First Submitted Date  ICMJE May 4, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE May 1, 2019
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2019)
  • unacceptable toxicity [ Time Frame: 1 year ]
    "Unacceptable toxicity" is defined as any of the following toxicities: >1 episode of grade 3/4 neutropenia or thrombocytopenia <75,000/μL (despite prior dose reduction) during chemoradiation any toxicity that results in >2 week cumulative delay in chemoradiation any toxicity that is attributed to durvalumab which results in a delay of >8 weeks in surgery, i.e. surgery >16 weeks from the end of radiation, for a potentially operable patient any reason that is attributed to durvalumab which leads to death within 30 days of surgery
  • pathologic complete response rate, pCR [ Time Frame: 1 year ]
  • major pahological response, MPR [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
Official Title  ICMJE A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
Brief Summary The purpose of this study is to test the the efficacy and safety of sintilimab in combination with chemoradiation before surgery for esophageal cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Esophageal Squamous Cell Carcinoma
Intervention  ICMJE
  • Biological: Sintilimab
    Other Name: (IBI308)
  • Drug: carboplatin/paclitaxel
    carboplatin AUC 2/paclitaxel 50 mg/m2 weekly
  • Radiation: Radiation
    IMRT or VMAT
Study Arms  ICMJE Experimental: arm

Biological: Sintilimab For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1

Drug: Paclitaxel 50 mg/m^2 IV Q3W day 1, day 8 and day 15

Drug: carboplatin AUC: 2 IV Q3W day 1, day 8 and day 15

Radiotherapy:

1.8 Gy/fraction ×23 fractions Monday to Friday total dose of 41.4 Gy

Interventions:
  • Biological: Sintilimab
  • Drug: carboplatin/paclitaxel
  • Radiation: Radiation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2019) 		20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2022
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically confirmed esophageal squamous carcinoma
  • 18≤age≤75
  • ECOG PS is 0-1
  • TanyN+M0 or T3-4NanyM0 tumors
  • Patients must have surgically resectable disease treatable by esophagectomy, as assessed by a thoracic surgeon
  • No prior chemotherapy,radiotherapy and immunotherapy
  • Disease must be clinically limited to the esophagus
  • No esophageal perforation and no active esophageal bleeding
  • No interstitial pneumonia or history of interstitial pneumonia
  • FEV1>1.2L
  • Adequate organ function defined at baseline as: WBC ≥3,000/ L，ANC ≥1,500/ L，Platelets ≥100,000/ L，Hb ≥9 g/dl； Calculated creatinine clearance >40 ml/min using Cockcroft-Gault method: Males: Creatinine CL = Weight (kg) x (140 - Age) . (mL/min) 72 x serum creatinine (mg/dL)Female：Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)；Total serum bilirubin ≤1.5 mg/dL， AST/ALT ≤2.5× upper limit of normal，Mean QT interval corrected for heart rate (QTc) <470 ms calculated from 3 ECGs using Frediricia's Correction
  • Able to provide written informed consent
  • Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion Criteria:

  • Previous treatment with chemotherapy, radiotherapy or immunotherapy
  • Cervical esophageal cancer
  • Esophageal perforation or active esophageal bleeding
  • Interstitial pneumonia or history of interstitial pneumonia
  • Patients with evidence of metastatic disease
  • Chronic Hepatitis B or C infection (e.g. Hepatitis B surface Ag positive or detectable viral load for Hepatitis B or C). Patients with prior evidence of Hepatitis B or C without active infection are eligible
  • Autoimmune diseases (such as systemic lupus erythematosus, rheumatoid rthritis, inflammatory bowel disease, autoimmune thyroid disease), but allow the following diseases to enter the next stage of screening: type I diabetes, skin diseases without systemic treatment (such as vitiligo, psoriasis)
  • 14 days before the first dose, the patient had an active infection that required systemic treatment
  • Inability to understand or may not comply with test requirements
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ji yongling, MD 08613958085251 jiyl@zjcc.org.cn
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940001
Other Study ID Numbers  ICMJE ZJCH1903
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: chen ming, MD Zhejiang Cancer Hospital
Principal Investigator: chen qixun, MD Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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