- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946969
Sintilimab in Combination With Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer
Safety and Efficacy of Combination of Sintilimab and Platinum-based Chemotherapy in Neoadjuvant Treatment of Potentially Resectable Esophageal Cancer: An Open-lable, Single-arm, Exploratory Clinical Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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-
Jiangsu
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Nanjing, Jiangsu, China, 210029
- The First Affiliated Hospital with Nanjing Medical University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Histologically or cytologically confirmed esophageal squamous cell carcinoma.
The tumor is located in the middle or lower third of the esophagus ( more than 18cm below incisor), potentially resectable and requiring neoadjuvant therapy (T1b-3, Nany, M0 or T4a, N0-1, M0).
No prior treatment for this disease.
Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
Adequate bone marrow, liver, cardiac and renal function as assessed by the laboratory required by protocol.
Understand and voluntarily sign the informed consent(s).
Patients who are able to complete the treatment and follow-up according to the study plan.
Patients who have sufficient tissue samples and agree to provide their tissue samples and blood samples for detailed analysis.
Female patients in child bearing period must have evidence of negative pregnancy test and agree to take effective contraceptive measures during the study.
Exclusion Criteria:
Patients who may develop tracheoesophageal fistula or aortoesophageal fistula.
Patients suffering from severe malnutrition or needing tube feeding.
Uncured patients with other malignancies within 2 years.
Patients who have active autoimmune diseases or patients who are undergoing treatment of autoimmune diseases.
Patients who need systemic glucocorticosteroid treatment (more than 10mg prednisone daily or other equivalent drugs) within 7 days before the neoadjuvant therapy or other immunosuppressive drugs.
Patients who have immune deficiency.
Patients with active viral or bacterial infection who need systemic treatment within 7 days before the neoadjuvant therapy.
Patients with uncontrolled diabetes mellitus.
Patients with interstitial pulmonary disease, noninfectious pneumonia, or pulmonary fibrosis.
Patients with preexisting symptoms of sensory or motor nerve damage (greater than Grade 1, WHO) .
Patients who have received allogeneic organ or stem cell transplants.
Patients who are allergic to drugs or related ingredients in this study.
Patients who take part in clinical trials of other drugs or biological therapy at present.
Patients with any serious or unstable medical condition or mental illness.
Patients who are dependent on or addicted to alcohol or drugs.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1
Sintilimab will be administered prior to the chemotherapy in an interval of half an hour.
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Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for two cycles.
Other Names:
Liposomal Paclitaxel (135mg/m2), ivd, d1 + Cisplatin (25mg/m2), ivd, d1-3 + S-1 capsule (40mg), po, d1-14, repeated every 3 weeks for two cycles.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and feasibility
Time Frame: 20 months
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Safety is defined as the incidence of Grade 3-4 Treatment-Related Adverse Events (TRAEs) from the day of neoadjuvant therapy to 30 days after surgery or within 90 days after last neoadjuvant treatment.
Feasibility of surgery is defined as the incidence of TRAEs causing surgery delay of ≥30 days and/or inoperable patients.
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20 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MPR rate
Time Frame: 20 months
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Major Pathological Response (MPR) is defined as the presence of 10% or fewer viable cancer cells in the hematoxylin and eosin (H&E)-stained slides from the resected tumor following neoadjuvant treatment.
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20 months
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R0 resection rate
Time Frame: 20 months
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R0 resection is defined as no cancer cells are seen microscopically at the resection margin following surgery.
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20 months
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Recurrence-Free Survival (RFS)
Time Frame: 5 years
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Recurrence-Free Survival (RFS) is calculated from surgery to the date of recurrence or death.
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5 years
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Overall Survival (OS)
Time Frame: 5 years
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Overall Survival (OS) is calculated from the beginning of neoadjuvant treatment to the date of death from any cause.
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5 years
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exploratory Outcomes
Time Frame: 20 months
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Correlation between biomarkers, including tumor mutational burden (TMB), clonal mutations, genetic alterations, and circulating tumor DNA (ctDNA), and therapeutic response to neoadjuvant therapy will be explored.
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20 months
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Yanhong Gu, The First Affiliated Hospital with Nanjing Medical University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Carcinoma, Squamous Cell
- Esophageal Neoplasms
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- KEEP-G 03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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