A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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