Clinical trial NCT03940001: 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
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: unacceptable toxicity
timeFrame: 1 year
measure: pathologic complete response rate, pCR
timeFrame: 1 year
measure: major pahological response, MPR
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: chen ming, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang Cancer Hospital
name: chen qixun, MD
role: PRINCIPAL_INVESTIGATOR
References: