search
Back to results

A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

Primary Purpose

Esophageal Squamous Cell Carcinoma

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Sintilimab
carboplatin/paclitaxel
Radiation
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma

Eligibility Criteria

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

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

Sites / Locations

  • Zhejiang Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

arm

Arm Description

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

Outcomes

Primary Outcome Measures

unacceptable toxicity
"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
major pahological response, MPR

Secondary Outcome Measures

Full Information

First Posted
May 4, 2019
Last Updated
September 5, 2019
Sponsor
Zhejiang Cancer Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03940001
Brief Title
A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
Official Title
A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Anticipated)
Study Completion Date
May 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
arm
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Sintilimab
Intervention Description
Other Name: (IBI308)
Intervention Type
Drug
Intervention Name(s)
carboplatin/paclitaxel
Intervention Description
carboplatin AUC 2/paclitaxel 50 mg/m2 weekly
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
IMRT or VMAT
Primary Outcome Measure Information:
Title
unacceptable toxicity
Description
"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
Time Frame
1 year
Title
pathologic complete response rate, pCR
Time Frame
1 year
Title
major pahological response, MPR
Time Frame
1 year

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ji yongling, MD
Phone
08613958085251
Email
jiyl@zjcc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chen ming, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
chen qixun, MD
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ming Chen, M.D.
Phone
0086-571-88122068
Email
chenming@zjcc.org.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

We'll reach out to this number within 24 hrs