- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03726021
Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
Clinical Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This research study is a Phase 2 clinical trial. It will test the efficiency and safety of an investigational drug f Irinotecan,Oxaliplatin, and S1, with the goal of determining the OS of advanced pancreatic adenocarcinoma..
Subjects must have a newly diagnosed stage 4 untreated metastatic pancreatic ductal cancer and meet all inclusion/exclusion criteria.
Treatment consists of treatment with Irinotecan 165mg/m2, Oxaliplatin 85mg/m2 on day 1, and S1 40mg orally on day 1-14, every 21 days each cycle. Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: ketao lan, MD
- Phone Number: 84861966
- Email: kevinji78@163.com
Study Contact Backup
- Name: xiaoyan wang
- Phone Number: 84861966
Study Locations
-
-
-
Qingdao, China, 266042
- Qingdao Central Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
• Cytologically- or histologically-confirmed pancreatic adenocarcinoma or poorly differentiated pancreatic carcinoma that is metastatic to distant sites.
- Other histologies such as neuroendocrine and acinar cell carcinoma are excluded.
- No prior chemotherapy for locally advanced or metastatic pancreatic cancer.
- Patients are eligible if they received adjuvant treatment after surgical resection
- Participants are required to have measurable disease (RECIST v1.1), defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as > 20 mm with conventional techniques or as > 10 mm with spiral CT scan. See section 11 for the evaluation of measurable disease.
- Participants enrolled must have disease that is accessible for tumor biopsies and must agree to a pre-treatment tumor biopsy.
- Age ≥ 18 years. Because no dosing or adverse event data are currently available in participants <18 years of age, children are excluded from this study but will be eligible for future pediatric trials.
- ECOG performance status ≤2 (see Appendix A)
- Patients must have completed any major surgery or open biopsy ≥4 weeks from start of treatment.
Participants must have adequate organ and marrow function as defined below:
- Absolute neutrophil count ≥1,500/mcL
- Platelets ≥100,000/mcL
- Total bilirubin ≤1.5 × institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) ≤2.5 × institutional upper limit of normal
- Creatinine ≤1.5 × institutional upper limit of normal OR
- Creatinine clearance ≥60 mL/min/1.73 m2 for participants with creatinine levels above 1.5 × upper limit of normal.
- Negative serum pregnancy test for women of childbearing potential.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
• Prior chemotherapy or any other investigational agents for the treatment of locally advanced or metastatic pancreatic cancer
- Concurrent use of any other anti-cancer therapy, including chemotherapy, targeted therapy, immunotherapy, or biological agents.
- Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events. Screening for brain metastases with head imaging is not required.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to above drugs or other agents used in study.
History of prior or current synchronous malignancy, except:
o Malignancy that was treated with curative intent and for which there has been no known active disease for >3 years prior to enrollment
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, NYHA class III/IV congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
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 |
---|---|
Experimental: experimental arm
Treatment consists of treatment with Irinotecan 165mg/m2, Oxaliplatin 85mg/m2 on day 1, and S1 40mg orally on day 1-14, every 21 days each cycle.
Treatment will be administered until untolerable toxicities or progression or subject death, or either the subject or sponsor discontinues the study.
|
Drug: Irinotecan is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells. Drug: Oxalipatin Oxaliplatin is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells Drug: S1 is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The overall survival in this population of patients.
Time Frame: Time Frame: 2 years
|
The overall survival of the enrolled patients from start the combination treatment of Irinotecan, Oxaliplatin, and S1.
|
Time Frame: 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The response rate in this population of patients.
Time Frame: Time Frame: 2 years
|
Number of participants with clinical response assessed by RECIST 1.1 criteria on imaging every 4 weeks with the combination of Irinotecan,Oxaliplatin, and S1.
|
Time Frame: 2 years
|
The progression free survival in this population of patients.
Time Frame: Time Frame: 2 years
|
The progression free survival of the enrolled patients from start the combination treatment with Irinotecan,Oxaliplatin, and S1.
|
Time Frame: 2 years
|
The toxicities in this population patients
Time Frame: Time Frame: 2 years
|
Adverse events were recorded and classified from start the treatment by grade according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0.
|
Time Frame: 2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- QDCH2018-10-28
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.
Clinical Trials on Overall Survival
-
Peking University First HospitalCompletedOverall SurvivalChina
-
Guangdong Association of Clinical TrialsUnknown
-
Peking University First HospitalPeking University Third Hospital; Beijing HospitalRecruitingSurgery | Elderly | Dexmedetomidine | Intensive Care Unit | Overall SurvivalChina
-
Shanghai Minimally Invasive Surgery CenterUnknownPostoperative Complications | Overall SurvivalChina
-
Hospital Universitario Virgen de la ArrixacaCompletedRecurrence | Overall Survival | Disease-free SurvivalSpain
-
Peking Union Medical College HospitalOrigiMedRecruitingQuality of Life | Objective Response Rate | Overall Survival | Progression-free Survival | Disease Control Rate | Duration of Response | Five-year Survival RateChina
-
Shanghai CP Guojian Pharmaceutical Co., Ltd.CompletedAdverse Events | Progress-free Survival | Overall Response Rate
-
Qingdao Central HospitalRecruiting
-
Peking University People's HospitalXijing Hospital; Peking Union Medical College Hospital; Chinese PLA General Hospital and other collaboratorsWithdrawnToxicity | Overall Survival | Progression-free SurvivalChina
-
Shanghai Minimally Invasive Surgery CenterUnknownPostoperative Complications | Overall SurvivalChina
Clinical Trials on Irinotecan,Oxaliplatin, and S1
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
Fudan UniversityRecruitingCarcinoma, Pancreatic DuctalChina
-
Yu jirenRecruitingAdenocarcinoma of the Stomach | Mismatch Repair Deficiency | Adenocarcinoma of Esophagogastric JunctionChina
-
Yu jirenNot yet recruitingAdenocarcinoma of the Stomach | Adenocarcinoma of Esophagogastric Junction | Epstein-Barr Virus-Associated Gastric CarcinomaChina
-
Yu jirenRecruitingAdenocarcinoma of the Stomach | Adenocarcinoma of Esophagogastric Junction | Proficient Mismatch RepairChina
-
Fudan UniversityUnknown
-
Liangjun Zhu M.M.Zhangjiagang First People's HospitalRecruitingMetastatic or Recurrent Gastric AdenocarcinomaChina
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
Cancer Institute and Hospital, Chinese Academy...Completed
-
Chinese PLA General HospitalNot yet recruiting