A Study of Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer

• Sponsor: Zhejiang Cancer Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03940001
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 36
• Patients Per Site Per Month: 0.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Squamous Cell Carcinoma	Biological: Sintilimab; Drug: carboplatin/paclitaxel; Radiation: Radiation	Early Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study of Anti-PD-1 Antibody, Sintilimab Plus Chemoradiation Before Surgery for Esophageal Cancer
• Actual Study Start Date: May 1, 2019
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: arm 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	Biological: Sintilimab; Other Name: (IBI308); Drug: carboplatin/paclitaxel; carboplatin AUC 2/paclitaxel 50 mg/m2 weekly; Radiation: Radiation; IMRT or VMAT

Outcome Measures

Primary Outcome Measures

1. unacceptable toxicity [1 year]

   "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

2. pathologic complete response rate, pCR [1 year]

3. major pahological response, MPR [1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zhejiang Cancer Hospital	Hangzhou	Zhejiang	China	310022

Sponsors and Collaborators

• Zhejiang Cancer Hospital

Investigators

• Principal Investigator: chen ming, MD, Zhejiang Cancer Hospital
• Principal Investigator: chen qixun, MD, Zhejiang Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhejiang Cancer Hospital
• ClinicalTrials.gov Identifier: NCT03940001
• Other Study ID Numbers: ZJCH1903
• First Posted: May 7, 2019
• Last Update Posted: Sep 9, 2019
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Paclitaxel; Carboplatin

Study Results

No Results Posted as of Sep 9, 2019