A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

University of Chinese Academy Sciences

Status and phase: Unknown; Early Phase 1

Conditions: Esophageal Squamous Cell Carcinoma

Treatments: Drug: carboplatin/paclitaxel; Biological: Sintilimab; Radiation: Radiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03940001

ZJCH1903

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

arm

Experimental group

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

Treatment:

Radiation: Radiation

Drug: carboplatin/paclitaxel

Biological: Sintilimab