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
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aims to investigate the safety and efficacy of sintilimab combined with platinum-based chemotherapy in neoadjuvant treatment of potentially resectable esophageal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2019
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 9, 2019
CompletedStudy Start
First participant enrolled
May 9, 2019
CompletedFirst Posted
Study publicly available on registry
May 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2022
CompletedJuly 19, 2022
July 1, 2022
2.5 years
May 9, 2019
July 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and feasibility
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.
20 months
Secondary Outcomes (4)
MPR rate
20 months
R0 resection rate
20 months
Recurrence-Free Survival (RFS)
5 years
Overall Survival (OS)
5 years
Other Outcomes (1)
Exploratory Outcomes
20 months
Study Arms (1)
Sintilimab + Liposomal Paclitaxel + Cisplatin + S-1
EXPERIMENTALSintilimab will be administered prior to the chemotherapy in an interval of half an hour.
Interventions
Sintilimab (200mg) will be given intravenously on day 1 in 3-week cycles for two cycles.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029, China
Related Publications (1)
Chen X, Xu X, Wang D, Liu J, Sun J, Lu M, Wang R, Hui B, Li X, Zhou C, Wang M, Qiu T, Cui S, Sun N, Li Y, Wang F, Liu C, Shao Y, Luo J, Gu Y. Neoadjuvant sintilimab and chemotherapy in patients with potentially resectable esophageal squamous cell carcinoma (KEEP-G 03): an open-label, single-arm, phase 2 trial. J Immunother Cancer. 2023 Feb;11(2):e005830. doi: 10.1136/jitc-2022-005830.
PMID: 36759013DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanhong Gu
The First Affiliated Hospital with Nanjing Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 9, 2019
First Posted
May 13, 2019
Study Start
May 9, 2019
Primary Completion
November 9, 2021
Study Completion
October 31, 2022
Last Updated
July 19, 2022
Record last verified: 2022-07
Data Sharing
- IPD Sharing
- Will not share