68Ga FAPI in Total Neoadjuvant Therapy of Rectal Cancer

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

The goal of the trial is to observe the changes of 68Ga FAPI signal before and after total neoadjuvant therapy for rectal cancers, and the correlation between the image parameters, immune checkpoints expression as well as the patient outcome. The trial will recruit patients with biopsy-confirmed rectal cancer aged 18 years old or older, with WHO/ECOG Performance Status 0-1, and eligible for total neoadjuvant therapy at the clinicians' discretion. After signing the informed consent, the participants will undergo a standard staging work-up if not already done, including colonoscopy and cross-sectional images such as CT, MR, and FDG-PET. Kidney function (by serum creatinine) and liver function (by serum alanine aminotransferase) will also be assessed. Only patients with stage II-III rectal cancer will be recruited. If patients meet the inclusion and exclusion criteria, they will undergo the first 68Ga-FAPI PET within 30 days before the beginning of total neoadjuvant therapy. At 22-24 weeks into the TNT, follow-ups for response evaluation will be conducted, including colonoscopy and cross-sectional images such as CT, MR, and FDG-PET. The second 68Ga-FAPI PET will be performed within one month of these exams. Afterward, participants will either undergo surgery or have image follow-ups every 3 months. The participants will be followed up for up to 2 years after the second 68Ga-FAPI PET, and immunochemical staining with CD47, CD73, PD-L1, and FAP on the biopsy or surgical specimens will be performed in one batch to avoid batch-to-batch variation.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Biopsy proven newly detected adenocarcinoma of the rectum

• Clinical stage II-III rectal cancer

• Aged at least 18 years. No upper age limit.

• WHO/ECOG Performance Status 0-1

• Eligible for total neoadjuvant therapy

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Shih-hsin Chen, MD PhD
yevgenyc@cgmh.org.tw
886-3-3281200
Time Frame
Start Date: 2024-03-08
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 99
Treatments
observation
Ga-68 FAPI study before and during TNT
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital
Collaborators: National Science and Technology Council

This content was sourced from clinicaltrials.gov