FAPI in Rectal Cancer TNT

Sponsor

Chang Gung Memorial Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06157463

Collaborator

National Science and Technology Council (U.S. Fed)

Enrollment

Location

Anticipated Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Neoplasms Malignant	Radiation: Ga-68 FAPI

Study Design

Study Type:

Observational

Anticipated Enrollment :

99 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

68Ga FAPI in Total Neoadjuvant Therapy of Rectal Cancer

Anticipated Study Start Date :

Dec 1, 2023

Anticipated Primary Completion Date :

Jul 31, 2026

Anticipated Study Completion Date :

Jul 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
observation Ga-68 FAPI study before and during TNT	Radiation: Ga-68 FAPI FAPI PET scans will be performed in addition to other staging/restaging work-up

Arm

Intervention/Treatment

observation

Ga-68 FAPI study before and during TNT

Radiation: Ga-68 FAPI

FAPI PET scans will be performed in addition to other staging/restaging work-up

Outcome Measures

Primary Outcome Measures

Change of FAPI SUV [before TNT & 22-24wk into TNT]
To compare the FAPI uptake after TNT

Secondary Outcome Measures

Correlation of FAPI SUV [2 years after recruitment]
FAPI SUV will be correlated with (1) 2-year disease-free survival (DFS), (2) 2-year local regional recurrence (LRR), (3) 2-year total mesorectal excision (TME)-free survival, (4) 2-year overall survival (OS), (5) overall complete response (CR) rate, and (6) immune checkpoint protein expression including CD47, CD73, PD-L1, and FAP

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Distant metastases found on either CT, MR or FDG-PET
Prior anticancer therapy for colorectal cancer
Prior radiotherapy of the pelvic region
Other concurrent antineoplastic therapy
Major surgery within the last 4 weeks prior to inclusion
Subjects pregnant or breast feeding
Serious concurrent diseases not compatible with study entry, including active, uncontrolled infections, active, disseminated coagulation disorder, clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia within 6 months before enrolment)
Neurologic or psychiatric disorders including dementia, uncontrolled seizures, substance abuses, severe depression
Prior or concurrent malignancy within 3 years prior to enrolment (except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1)
Allergic to contrast agents or to the main ingredients or excipients of the experimental radiopharmaceutical 68Ga FAPI, including acetate, ascorbic acid and normal saline
Those deemed unsuitable for participation in the trial by the investigators.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Taoyuan		Taiwan	333

Sponsors and Collaborators

Chang Gung Memorial Hospital
National Science and Technology Council

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Chang Gung Memorial Hospital

ClinicalTrials.gov Identifier:

NCT06157463

Other Study ID Numbers:

202202030A0C601

First Posted:

Dec 5, 2023

Last Update Posted:

Dec 5, 2023

Last Verified:

Nov 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Rectal Neoplasms

Neoplasms

Study Results

No Results Posted as of Dec 5, 2023