AzTrials
AzTrials

Overall SurvivalPhase 2NCT03726021

Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer

A Phase 2 study testing Irinotecan,Oxaliplatin, and S1 in people with Overall Survival, run by Qingdao Central Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To identify the efficiency of Irinotecan, Oxaliplatin, and S1 in patients with previously untreated local regional or metastatic pancreatic cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Overall Survival
What is being tested?
Irinotecan,Oxaliplatin, and S1
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
26 Jan 2018to 28 Feb 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • • 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.
Show all 18Show fewer
  • 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

Who cannot join

  • • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Qingdao Central Hospital

    Qingdao, 266042

Other trials in China

About this study

Official title: Clinical Study of Irinotecan,Oxaliplatin, and S1 in Patients With Advanced Pancreatic Cancer

To identify the efficiency of Irinotecan, Oxaliplatin, and S1 in patients with previously untreated local regional or metastatic pancreatic cancer.

Read the 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.

Being tested
Irinotecan,Oxaliplatin, and S1
Keywords
overall survival; Irinotecan; Oxaliplatin; S1; Chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan,Oxaliplatin, and S1Drug

    Also called CPT-11/L-OHP/TS-1

    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

Study groups in NCT03726021
Study groupRoleWhat they receive
experimental armExperimentalTreatment 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.
Receives: Drug: Irinotecan,Oxaliplatin, and S1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The overall survival in this population of patients.

    The overall survival of the enrolled patients from start the combination treatment of Irinotecan, Oxaliplatin, and S1.

    Measured: Time Frame: 2 years

Secondary outcomes (3)

  1. The response rate in this population of patients.

    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.

    Measured: Time Frame: 2 years

  2. The progression free survival in this population of patients.

    The progression free survival of the enrolled patients from start the combination treatment with Irinotecan,Oxaliplatin, and S1.

    Measured: Time Frame: 2 years

  3. The toxicities in this population patients

    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.

    Measured: Time Frame: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2018
  2. Study start26 Jan 2018
  3. Primary completion31 Dec 2022
  4. Study completion28 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Experimental: Irinotecan,Oxaliplatin, and S1 * S1 will be administered orally days 1 and 14 of a 21 day cycle * Irrinotecan 165 mg/m2 and Oxaliplatin 85mg/m2 will be administered IV days 1 of a 21 day cycle.
Masking
None (open label)
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03726021
Sponsor's protocol ID
QDCH2018-10-28
Status last verified
Mar 2023
First submitted
27 Oct 2018
Last updated
29 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nie K, Zhang L, You Y, Li H, Guo X, Zhang Z, Zhang C, Ji Y. Irinotecan combined with oxaliplatin and S-1 in patients with metastatic pancreatic adenocarcinoma: a single-arm, three-centre, prospective study. Ther Adv Med Oncol. 2020 Nov 12;12:1758835920970843. doi: 10.1177/1758835920970843. eCollection 2020.

    PubMed 33240399

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan,Oxaliplatin, and S1 in people with Overall Survival, run by Qingdao Central Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The overall survival in this population of patients. (time frame: Time Frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03726021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in