ImmunotherapyNCT04500990
MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
An observational study of Immunotherapy and Digestive System Neoplasm, run by Peking University at 1 site in China.
Trial summary
This is a prospective two cohorts observational study aimed to investigate the predicting value of MRI none-Gaussian model in digestive malignancies patients who received single agent PD-1/PD-L1 inhibitor or combined immunotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Immunotherapy, Digestive System Neoplasm
- What is being tested?
- MRI test
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Sep 2020to Jul 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients receive treatment in Beijing Cancer Hospital.
Who may be able to join
- age ≥ 18 years, ECOG 0-1, expected survival ≥3 months;
- pathologically confirmed digestive system adenocarcinoma, including but not restricted to gastric adenocarcinoma, colorectal cancer, pancreatic adenocarcinoma et al;
- pathologically confirmed PD-L1 expression, or MMR-deficient (dMMR)/microsatellite instability (MSI-H) or high tumor mutation burden (TMB-H) or other indication for immunotherapy;
- at least one target lesion, if there is no target lesion the thickness of cavity viscera lesion should exceed 1cm;
- patients will receive single agent PD-1/PD-L1 inhibitor, or combined immunotherapy such as: lenvatinib, enrotinib or herceptin;
- screening laboratory values must meet the following criteria: hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10^3/ μL; total bilirubin ≤ 2.0 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5 x ULN, and serum creatinine rate >50μmol/L; activated partial thromboplastin time (APTT)、international normalized ratio (INR), prothrombin lime (PT)≤1.5×ULN;
- echocardiography: left ventricular ejection fraction≥50%
- volunteer participate, signed written informed consent form.
Who cannot join
- claustrophobia or other contraindication for MRI testing;
- received prior anti-PD-1/PD-L1 or other immune checkpoint inhibitors;
- combined immunotherapy contains chemotherapy agent;
- contain other histology component except adenocarcinoma；
- hypersensitivity after other monoclonal antibody infusion；
- coexist other malignancy in last five years;
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- active autoimmune disease, or who received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of first dose;
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage;
- obvious bleeding tendency or had CTCAE≥3 grade；
- subjects are eligible with clinically controlled and stable neurologic function ≥ 4 weeks, which is no evidence of CNS disease progression; subjects with spinal cord compression and cancerous meningitis are not eligible；
- vaccination within 28 days of the first administration of trial treatment.
Trial locations and contacts
1 site in 1 country.
Lin Shen, MD PhD contact
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Shen Lin, Professor, 010-88196561, Linshenpku@163.com
Shen Lin, professor
About this study
Official title: Magnetic Resonance Imaging (MRI) Diffusion-weighted Imaging (Dwi) None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
This is a prospective two cohorts observational study aimed to investigate the predicting value of MRI none-Gaussian model in digestive malignancies patients who received single agent PD-1/PD-L1 inhibitor or combined immunotherapy.
- Conditions
- Immunotherapy, Digestive System Neoplasm
- Being tested
- MRI test
- Keywords
- MRI, DWI, Digestive system malignancies, Early response
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI testRadiation
Patients will receive diagnostic MRI test on d0.
MRI testRadiation
Patients will receive diagnostic MRI test on d8±1.
MRI testRadiation
Patients will receive diagnostic MRI test on d30±2.
| Study group | Role | What they receive |
|---|---|---|
| Single agent PD-1/PD-L1 inhibitor | Patients will receive single agent PD-1/PD-L1 inhibitor in a predefined group. Receives: Radiation: MRI test | |
| Combined immunotherapy | Patients will receive combined immunotherapy in a predefined group. PD-1/PD-L1 inhibitor will be combined with target therapy, such as lenvatinib, enrotinib, herceptin et al. Receives: Radiation: MRI test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
The rate of patients reached complete response or partial response.
Measured: from enrollment of the first subject until the database cut-off approximately 12 months later.
Secondary outcomes (2)
Progress free survival
the time from enrollment to disease progression or death or loss of follow-up.
Measured: from enrollment of the first subject until the database cut-off approximately 12 months later.
Overall survival
the time from enrollment to death or loss of follow-up.
Measured: from enrollment of the first subject until the database cut-off approximately 12 months later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study startSep 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, professor, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04500990
- Sponsor's protocol ID
- MRI immunotherapy
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Imaging (MRI) Diffusion-weighted Imaging (Dwi) None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT04500990
- Acronym / sponsor ID
- MRI immunotherapy
- Conditions
- Immunotherapy, Digestive System Neoplasm
- Keywords
- MRI, DWI, Digestive system malignancies, Early response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Sep 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 6 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective two cohorts observational study aimed to investigate the predicting value of MRI none-Gaussian model in digestive malignancies patients who received single agent PD-1/PD-L1 inhibitor or combined immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single agent PD-1/PD-L1 inhibitor | – | Radiation: MRI testPatients will receive single agent PD-1/PD-L1 inhibitor in a predefined group. |
| Combined immunotherapy | – | Radiation: MRI testPatients will receive combined immunotherapy in a predefined group. PD-1/PD-L1 inhibitor will be combined with target therapy, such as lenvatinib, enrotinib, herceptin et al. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients receive treatment in Beijing Cancer Hospital.
Key inclusion criteria (8 listed)
- age ≥ 18 years, ECOG 0-1, expected survival ≥3 months;
- pathologically confirmed digestive system adenocarcinoma, including but not restricted to gastric adenocarcinoma, colorectal cancer, pancreatic adenocarcinoma et al;
- pathologically confirmed PD-L1 expression, or MMR-deficient (dMMR)/microsatellite instability (MSI-H) or high tumor mutation burden (TMB-H) or other indication for immunotherapy;
- at least one target lesion, if there is no target lesion the thickness of cavity viscera lesion should exceed 1cm;
- patients will receive single agent PD-1/PD-L1 inhibitor, or combined immunotherapy such as: lenvatinib, enrotinib or herceptin;
Key exclusion criteria (11 listed)
- claustrophobia or other contraindication for MRI testing;
- received prior anti-PD-1/PD-L1 or other immune checkpoint inhibitors;
- combined immunotherapy contains chemotherapy agent;
- contain other histology component except adenocarcinoma；
- hypersensitivity after other monoclonal antibody infusion；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI testPatients will receive diagnostic MRI test on d0. | Radiation | Combined immunotherapy, Single agent PD-1/PD-L1 inhibitor |
| MRI testPatients will receive diagnostic MRI test on d8±1. | Radiation | Combined immunotherapy, Single agent PD-1/PD-L1 inhibitor |
| MRI testPatients will receive diagnostic MRI test on d30±2. | Radiation | Combined immunotherapy, Single agent PD-1/PD-L1 inhibitor |
Primary outcome
Objective Response Rate
Time frame: from enrollment of the first subject until the database cut-off approximately 12 months later.
The rate of patients reached complete response or partial response.
2 secondary outcomes
Progress free survival
Time frame: from enrollment of the first subject until the database cut-off approximately 12 months later.
Overall survival
Time frame: from enrollment of the first subject until the database cut-off approximately 12 months later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lin Shen, MD PhD contact
Lin Shen, professor principal investigator
Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Immunotherapy and Digestive System Neoplasm, run by Peking University 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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 6 Aug 2020. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Shen, professor (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: from enrollment of the first subject until the database cut-off approximately 12 months later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2020.