Hepatobiliary MalignancyNCT06597539
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
An observational study of Hepatobiliary Malignancy, run by Ruijin Hospital at 1 site in China.
Trial summary
This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatobiliary Malignancy
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Nov 2024to 31 Jul 2027
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.
Who may be able to join
- Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
- Signed and dated informed consent form
- Commitment to comply with research procedures and co-operation in the implementation of the full research process
- aged 18-75 years old
- The patient is in good general condition with an expected survival of \> 6 months
Who cannot join
- Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- Intestinal perforation, complete intestinal obstruction
- Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Non-compliant person
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine
Shanghai, Shanghai Municipality, 200025
Feng Ye, 0086-13916720995, yf12110@rjh.com.cn
Biao Li
About this study
Official title: A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.
Read the detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.
- Conditions
- Hepatobiliary Malignancy
- Keywords
- 68Ga-grazytracer PET/CT, Immunotherapy, Advanced hepatobiliary malignancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Diagnosis of advanced hepatobiliary malignancies | Patients diagnosis of advanced hepatobiliary malignancies require immunotherapy or combination immunotherapy after evaluation according to clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy
The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of advanced hepatobiliary malignancy
Measured: up to 9 weeks
Standardized uptake value(SUV)
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Measured: up to 9 weeks
Target-to-background ratio(TBR)
68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.
Measured: up to 9 weeks
Secondary outcomes (2)
Progress free survival
Progress free survival
Measured: 1 years
Overall survival
Overall survival
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Nov 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatobiliary MalignancyStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hu Jiajia, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597539
- Sponsor's protocol ID
- RuijinH 2024-232
- Status last verified
- Sep 2024
- First submitted
- 10 Sep 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on Investigating the Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy
- ClinicalTrials.gov ID
- NCT06597539
- Acronym / sponsor ID
- RuijinH 2024-232
- Conditions
- Hepatobiliary Malignancy
- Keywords
- 68Ga-grazytracer PET/CT, Immunotherapy, Advanced hepatobiliary malignancy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 9 Nov 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Sep 2024 (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 study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.
Detailed description
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnosis of advanced hepatobiliary malignancies | – | –Patients diagnosis of advanced hepatobiliary malignancies require immunotherapy or combination immunotherapy after evaluation according to clinical guidelines |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.
Key inclusion criteria (5 listed)
- Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
- Signed and dated informed consent form
- Commitment to comply with research procedures and co-operation in the implementation of the full research process
- aged 18-75 years old
- The patient is in good general condition with an expected survival of \> 6 months
Key exclusion criteria (5 listed)
- Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- Intestinal perforation, complete intestinal obstruction
- Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
- Pregnant women and women who may be pregnant, women who are breastfeeding.
- Non-compliant person
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy
Time frame: up to 9 weeks
The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of advanced hepatobiliary malignancy
Standardized uptake value(SUV)
Time frame: up to 9 weeks
SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions
Target-to-background ratio(TBR)
Time frame: up to 9 weeks
68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.
2 secondary outcomes
Progress free survival
Time frame: 1 years
Overall survival
Time frame: 1 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- 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.
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 Hepatobiliary Malignancy, run by Ruijin 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajia Hu (0086-13524945287, jiajiahu@shsmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy (time frame: up to 9 weeks). The study lists 3 primary outcomes in all. 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 11 Dec 2024.