- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04065282
The Purpose of This Study is to Evaluate the Efficacy and Safety of Sintilimab in Combination With Xelox as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
February 7, 2020 updated by: jianghaiping, First Affiliated Hospital of Zhejiang University
A Prospective, Multicenter, Single-armed, Phase II Study Evaluating Efficacy and Safety of Neoadjuvant Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) in Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.
Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) as Neoadjuvant Therapy in patients With Resectable Locally Advanced Gastric Cancer
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
This prospective, multicenter, single-armed, phase II study will evaluate efficacy and safety of Sintilimab in combination with Xelox (Oxaliplatin 130mg/m2 iv d1 Q3w and Capecitabine 1000mg/m2 po Bid d1-14 Q3W) as neoadjuvant therapy in patients with resectable locally advanced gastric or gastroesophageal adenocarcinoma(G/GEJ AC).
Newly diagnosed, treatment naïve patients with resectable locally advanced gastric or G/GEJ AC will be eligible to receive up to 3 cycles of sintilimab plus Xelox regimen as neoadjuvant therapy.
Following radical gastrectomy will be performed within one to four weeks since last dosing for patients with resectable cancer after radiological evaluation.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haiping Jiang, PhD
- Phone Number: 0571-87235896
- Email: jianghaiping75@163.com
Study Locations
-
-
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Zhejiang, China
- Recruiting
- First affiliated Hospital of Zhejiang University
-
Contact:
- haiping jiang, PhD
- Phone Number: 0571-87235896
- Email: lsteng@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 73 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically proven adenocarcinoma of the stomach.
- The primary tumor locates at stomach or esophagogastroesophageal ic junction.
- Clinical T3-4NxM0 disease, confirmed by enhanced contrast abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
- At least one measurable lesion.
- Resectable gastric or gastroesophageal cancer, judged by surgeons in this studyEligible and reasonably suitable for potentially curative resection
- ECOG performance status 0-1.
- Adequate organ function for chemotherapy and surgical treatment, as evaluated by laboratory tests.
- Written (signed) informed consent.
- Good compliance with the study procedures, including lab and auxiliary examination and treatment.
- Agree to use an approved contraceptive method during the treatment period, until 120 days after last dose of Sintilimab or 180 days after last dose of chemotherapy.
Exclusion Criteria:
- Unsectable primary tumor or any distant metastatic disease.
- Received any anti-cancer therapy for this disease, including radiation therapies, chemotherapies, immunotherapies, and Chinese traditional herb therapies.
- Clinical T1-2N0M0 disease, confirmed by CT/MRI or endoscopic ultrasonography.
- Active autoimmune disease or history of refractory autoimmune disease.
- History of any other malignant tumor within 2 years, excluding cured local tumor, such as resected skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or ductal carcinoma in situ (DCIS).
- History of gastrointestinal hemorrhage within 2 weeks before enrollment or patients with a high risk of hemorrhage.
- History of gastrointestinal perforation within 6 months before enrollment.
- Gastrointestinal obstruction, gastrointestinal dysfunction, or malabsorption syndrome that may affect the absorption of Capecitabine.
- Weight loss is greater than 20% within 2 months before enrollment.
- History of severe pulmonary disease, including but not limited to interstitial pulmonary disease, noninfectious pneumonitis, pulmonary fibrosis, acute pulmonary disease
- Uncontrolled systematic disease, including diabetes mellitus, hypertension, etc.
- Severe chronic or active infectious disease that needs systematic antibiotics, antifungal, or antiviral therapies.
- Untreated chronic hepatitis B, serum HBV DNA load higher than the lower threshold of the test, or HCV RNA positive.
With any cardiovascular risk factors as follow:
- History of angina within 28 days before enrollment, defined as moderate pain affecting daily activities;
- History of symptomatic pulmonary embolism within 28 days before enrollment;
- History of acute myocardial infarction within 6 months before enrollment;
- History of NYHA class III/IV heart failure within 6 months before enrollment;
- History of grade 2 (Lown grading system) or menopause ventricular arrhythmias or history of supraventricular arrhythmias that needs treatment within 6 months before enrollment;
- History of cerebrovascular accident within 6 months before enrollment;
- grade 1 Peripheral neuropathy , excluding patients with only deep tendon reflex absence.]
- Known Dihydropyrimidine dehydrogenase (DPD) deficiency.
- Known allergic to any drug used in this study.
- History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Receiving corticosteroid (> 10mg/d prednisone or equivalent dose of steroids) or other systematic immunosuppression therapies within 14 days before enrollment, excluding following therapies:
- steroid hormone replacement therapy (≤10mg/d);
- local steroid therapy;
- short-term, prophylactic steroid therapy for preventing allergies or nausea and vomiting
- Receiving attenuated vaccine within 4 weeks before enrollment.
- Receiving immunotherapy or other study drugs within 28 days before enrollment,
- History of receiving anti-PD-1, anti-PD-L1, anti-PD-L2, or any other T cell co-simulation or checkpoint inhibitor therapy.
- Receiving major surgery within 28 days before enrollment.
- For patients with uncontrolled epilepsy, central nervous system disease, or mental disorder, researchers should evaluate if the inform consent and/or the compliance would be affected by their disease.
- Any drug or alcohol abuse that would affect drug management or toxicity analysis.
- Pregnant or nursing female.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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 |
---|---|
Experimental: neoadjuvant therapy with Sintilimab plus Xelox
3 cycles of neoadjuvant therapy: Sintilimab iv d1 Q3W, Oxaliplatin 130mg/m2 iv d1 Q3W, and Capecitabine 1000mg/m2 po Bid d1-14 Q3W
|
3 cycles before radical surgery
Other Names:
85mg/m2 Q3W, 3 cycles perioperation
1000mg/m2 bid po D1~14 Q3W, 3 cycles perioperation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pathological complete response rate (pCR)
Time Frame: after surgical resection (up to 12 weeks after first dosing)
|
evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.
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after surgical resection (up to 12 weeks after first dosing)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR)
Time Frame: 9 to 12 weeks
|
9 to 12 weeks
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Tumor regression grade (TRG)
Time Frame: after surgical resection (up to 12 weeks after first dosing)
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after surgical resection (up to 12 weeks after first dosing)
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Disease free survival (DFS)
Time Frame: every 90 days after resection, up to 2 years
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every 90 days after resection, up to 2 years
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1-year overall survival rate
Time Frame: 1 years
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1 years
|
2-year overall survival rate
Time Frame: 2 years
|
2 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival (OS)
Time Frame: up to 5 years
|
The relation between overall survival and pathological response after neoadjuvant therapy of Sintilimab plus Xelox for gastric cancer
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up to 5 years
|
PD-L1 expression, tumor infiltrating lymphocytes (TIL), etc.
Time Frame: after surgical resection (up to 12 weeks after first dosing)
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The relation between treatment efficacy and biomarker in tumor tissue
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after surgical resection (up to 12 weeks after first dosing)
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Cytokine (IL-6)
Time Frame: up to 12 weeks after first dosing
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The relation between treatment efficacy and biomarker in peripheral blood
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up to 12 weeks after first dosing
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immune cell subpopulation (CD3, CD4, CD8 lymphocytes )
Time Frame: up to 12 weeks after first dosing
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The relation between treatment efficacy and biomarker in peripheral blood
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up to 12 weeks after first dosing
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 6, 2019
Primary Completion (Anticipated)
March 1, 2020
Study Completion (Anticipated)
March 1, 2022
Study Registration Dates
First Submitted
August 15, 2019
First Submitted That Met QC Criteria
August 21, 2019
First Posted (Actual)
August 22, 2019
Study Record Updates
Last Update Posted (Actual)
February 10, 2020
Last Update Submitted That Met QC Criteria
February 7, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIBI308Y030
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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