A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

Esophageal Squamous Cell Carcinoma Clinical Trial

Official title:

A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03940001
• Other study ID #: ZJCH1903
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 1, 2019
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2019
• Source: Zhejiang Cancer Hospital
• Contact: ji yongling, MD
• Phone: 08613958085251
• Email: jiyl[@]zjcc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Esophageal Squamous Cell Carcinoma

Intervention

Biological:
• Sintilimab
Other Name: (IBI308)

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

Radiation:
• Radiation
IMRT or VMAT

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	pathologic complete response rate, pCR		1 year
Primary	major pahological response, MPR		1 year