NCT05662488

Brief Summary

The purpose of this study is to explore the ability of positron emission tomography (PET) with \[68Ga\]FAPI to detect, evaluate treatment response, and predict prognosis in advanced liver and biliary cancer patients treated with anti-PD-1 antibodies-based combination therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2022

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 22, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2023

Completed
Last Updated

December 22, 2022

Status Verified

December 1, 2022

Enrollment Period

2 years

First QC Date

December 5, 2022

Last Update Submit

December 14, 2022

Conditions

Hepatocellular CarcinomaBile Duct Cancer

Outcome Measures

Primary Outcomes (6)

  • Baseline SUVmax on [68Ga]FAPI and [18F] FDG PET Scans

    Baseline FAPI and FDG SUVmax, fibro-activation tumor volume (metabolic tumor volume), total lesion fibro-activation (total lesion glycolysis) before treatment were determined.

    through study completion, an average of 2 years

  • Baseline active tumor volume on [68Ga]FAPI and [18F] FDG PET Scans

    Baseline fibro-activation tumor volume and metabolic tumor volume before treatment were determined.

    through study completion, an average of 2 years

  • Baseline total lesion activation on [68Ga]FAPI and [18F] FDG PET Scans

    Baseline total lesion fibro-activation and total lesion glycolysis before treatment were determined.

    through study completion, an average of 2 years

  • Response of SUVmax to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans

    Changes in FAPI and FDG SUVmax during treatment were determined.

    through study completion, an average of 1 years

  • Response of active tumor volume to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans

    Changes in fibro-activation tumor volume and metabolic tumor volume during treatment were determined.

    through study completion, an average of 1 years

  • Response of total lesion activation to anti-PD1-based combination therapy shown in [68Ga]FAPI and [18F] FDG PET Scans

    Changes in total lesion fibro-activation and total lesion glycolysis during treatment were determined.

    through study completion, an average of 1 years

Secondary Outcomes (3)

  • Tumor response evaluated by CT and MRI

    through study completion, an average of 1 years

  • Overall survival after treatment

    through study completion, an average of 2 years

  • Progression-free survival after treatment

    through study completion, an average of 2 years

Interventions

[68Ga]FAPI PET/CT and [18F]FDG PET/CTDIAGNOSTIC_TEST

To perform \[68Ga\]FAPI PET/CT and \[18F\]FDG PET/CT in patients with advanced liver and biliary cancer before and after treatment with PD-1 Based Combination Therapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Advanced HCC or BTC patients who accept PD1-based combination therapy

You may qualify if:

  • locally advanced or metastatic and/or unresectable HCC or BTC
  • Child Pugh A or B liver function status
  • an ECOG performance status score of 0-2

You may not qualify if:

  • intolerance to anti-PD-1-based combination therapy
  • active or prior autoimmune disease
  • concurrent use of immunosuppressive medicaments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine, Peking Union Medical College Hopital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularBile Duct Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBiliary Tract NeoplasmsBile Duct DiseasesBiliary Tract Diseases

Study Officials

  • Li Huo

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2022

First Posted

December 22, 2022

Study Start

September 1, 2020

Primary Completion

August 30, 2022

Study Completion

August 30, 2023

Last Updated

December 22, 2022

Record last verified: 2022-12

Locations

CN(1)