The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorRuijin Hospital

About this trial

This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

Inpatients and outpatients at Ruijin Hospital who meet the inclusion criteria.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 1 trial group
Group A: Diagnosis of advanced hepatobiliary malignancies

Trial outcomes

Primary outcomes

1

Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy

The value of 68Ga-grazytracer PET in monitoring responses to immunotherapy of advanced hepatobiliary malignancy

Time frame
up to 9 weeks
2

Standardized uptake value(SUV)

SUV of 68Ga-grazytracer uptake on PET/CT images for tumor lesions

Time frame
up to 9 weeks
3

Target-to-background ratio(TBR)

68Ga-grazytracer uptake ratio of tumor lesions to mediastinum and liver blood pool on PET/CT images.

Time frame
up to 9 weeks

Secondary outcomes

1

Progress free survival

Progress free survival

Time frame
1 years
2

Overall survival

Overall survival

Time frame
1 years

Other outcomes

Sponsors and contacts

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