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

NCT06597539 | Recruiting DMC

• 1 other identifier: RuijinH 2024-232
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatobiliary Malignancy

Keywords

68Ga-grazytracer PET/CT; Immunotherapy; Advanced hepatobiliary malignancy

Outcome Measures

Primary Outcomes (3)

• Evaluation the responses to immunotherapy of advanced hepatobiliary malignancy

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

  up to 9 weeks

• Standardized uptake value(SUV)

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

  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.

  up to 9 weeks

Secondary Outcomes (2)

• Progress free survival

  1 years

• Overall survival

  1 years

Study Arms (1)

Diagnosis of advanced hepatobiliary malignancies

Patients diagnosis of advanced hepatobiliary malignancies require immunotherapy or combination immunotherapy after evaluation according to clinical guidelines

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital affiliated to Shanghai Jiao Tong University of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Central Study Contacts

Jiajia Hu

CONTACT

0086-13524945287; jiajiahu@shsmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: November 9, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: December 11, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)