- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05204173
Efficacy and Safety of Sintilimab Combined Intraperitoneal and Intravenous Paclitaxel Plus Oral S-1 in Gastric Cancer Patients With Peritoneal Metastasis
January 10, 2022 updated by: zhuzhenggang, Ruijin Hospital
In this phase 2 study, we combined sintilimab, paclitaxel and S-1 as regimen to treat gastric cancer patients with peritoneal metastasis.
We are aim to estimate the efficacy and safety of this regimen in the phase 2 study.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Gastric cancer patients enrolled in this a phase 2 study received sintilimab (200mg intravenously on day 1), paclitaxel (PTX) (20 mg/m2 intraperitoneally and 50 mg/m2 intravenously on days 1 and 8) plus oral S-1 (80 mg/m2 for 14 consecutive days) every 3 weeks.
The primary endpoint is 1-year survival rate.
Secondary endpoints are adverse events, R0 resection rate, 3-year overall survival (OS), and 3-year progressive free survival.
Adverse events are monitored and graded according to the Common Terminology Criteria for Adverse Events version 4.0.
Study Type
Interventional
Enrollment (Anticipated)
30
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: Zhongyin Yang, PhD
- Phone Number: 671304 8621-64370045
- Email: jeffreyyong@163.com
Study Contact Backup
- Name: Min Shi, PhD
- Phone Number: 8621-64370045
- Email: shimin0412005@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital Shanghai Jiao Tong University School of Medicine
-
Contact:
- Zhongyin Yang, PhD
- Phone Number: 671304 +862164370045
- Email: jeffreyyong@163.com
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed gastric adenocarcinoma;
- Peritoneal metastases from gastric cancer requiring definitive diagnosis by laparoscopy, and without gastric outflow tract obstruction and intestinal obstruction;
- Written (signed) informed consent;
- Age ≥ 18 years at registration;
- Eastern Cooperative Oncology Group (ECOG) score ≤ 2;
- Expected life expectancy > 3 months;
- Adequate bone marrow, liver, and renal functions. absolute neutrophil count of ≥1.5×109/L; absolute neutrophil count of ≥1.5×109/L; platelet count of ≥100×109/L; hemoglobin ≥90g/L; bilirubin of <1.5×upper limit of normal [ULN]; alanine aminotransferase and aspartate aminotransferase of <2.5×ULN; serum creatinine of ≤1.5×ULN; creatinine clearance of >50 mL/min; TSH ≤1×ULN (if abnormal, T3 and T4 levels should be inspected at the same time, if T3 and T4 levels are normal, they can be included in the group); APTT ≤1.5×ULN and INR ≤1.5×ULN; myocardial enzymogram ≤1×ULN.
Exclusion Criteria:
- Confirmed of evidence of distant metastasis other than peritoneal metastasis (e.g.liver metastasis, lung metastasis, para-aortic lymph node metastasis, etc.);
- During pregnancy, within 28 days of post parturition, or during lactation;
- Synchronous or metachronous (within 5 years) malignancies.
- Severe mental disease, uncontrolled epilepsy, or central nervous system disease;
- Clinically severe (i.e. active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure or arrhythmia requiring drug intervention, or a history of myocardial infarction in the last 12 months;
- Upper gastrointestinal obstruction or abnormal physiological function or malabsorption syndrome may affect S-1 absorbers;
- Known peripheral neuropathy (> NCI-CTC AE 1). However, patients with only disappearance of deep tendon reflex (DTR) need not be excluded;
- Patients on steroid or immunosuppressant treatment after organ transplant;
- Patients with severe uncontrolled recurrent infections or other severe uncontrolled concomitant disease;
- Moderate or severe renal damage [creatinine clearance ≤ 50 ml/min], or serum creatinine > upper limit of normal (ULN), 115 μmol/L;
- Known dihydropyrimidine dehydrogenase (DPD) deficiency;
- Anaphylaxis to paclitaxel or any research drug ingredient.
- Active autoimmune disease or history of refractory autoimmune disease; Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected;
- HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥10 copies/ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);
- Steroid or other systemic immunosuppressive therapy was used 14 days before admission, excluding local or physiological doses of systemic glucocorticoids (eg. no more than 10mg/day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents;
- Uncontrolled arrhythmia and myocardial infarction within 12 months before admission or active tuberculosis.
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: Intraperitoneal
Sintilimab 200mg intravenous (IV) infusion on day 1, PTX 50 mg/m2 IV and PTX 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days every 3 weeks.
|
Sintilimab 200mg intravenous (IV) infusion on day 1, PTX 50 mg/m2 IV and PTX 20 mg/m2 intraperitoneal infusion on Days 1 and 8 plus oral S-1 80 mg/m2 for 14 consecutive days with one week rest.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1-year survival rate
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame: 24 months
|
24 months
|
R0 resection rate
Time Frame: 24 months
|
24 months
|
3-year overall survival (OS)
Time Frame: 36 months
|
36 months
|
3-year progressive free survival (PFS)
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
May 20, 2021
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
December 25, 2021
First Submitted That Met QC Criteria
January 10, 2022
First Posted (Actual)
January 24, 2022
Study Record Updates
Last Update Posted (Actual)
January 24, 2022
Last Update Submitted That Met QC Criteria
January 10, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Neoplastic Processes
- Stomach Neoplasms
- Neoplasm Metastasis
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- DRAGON-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.
IPD Sharing Supporting Information Type
- Study Protocol
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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