Rectal Neoplasms MalignantNCT06157463
FAPI in Rectal Cancer TNT
An observational study of Rectal Neoplasms Malignant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Neoplasms Malignant
- What is being tested?
- Ga-68 FAPI
- Type of treatment
- Surgery or procedure
- How many people
- 99 participants
- Where
- 1 siteTaiwan
- Study dates
- 8 Mar 2024to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Those patient referred to the tertiary medical center for rectal cancer will be invited to enroll in the study.
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Shih-hsin Chen, MD PhD, 03-3281200 ext. 3565, yevgenyc@cgmh.org.tw
About this study
Official title: 68Ga FAPI in Total Neoadjuvant Therapy of Rectal Cancer
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.
- Conditions
- Rectal Neoplasms Malignant
- Being tested
- Ga-68 FAPI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga-68 FAPIRadiation
FAPI PET scans will be performed in addition to other staging/restaging work-up
| Study group | Role | What they receive |
|---|---|---|
| observation | Ga-68 FAPI study before and during TNT Receives: Radiation: Ga-68 FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of FAPI SUV
To compare the FAPI uptake after TNT
Measured: before TNT & 22-24wk into TNT
Secondary outcomes (1)
Correlation of FAPI SUV
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
Measured: 2 years after recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start8 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Neoplasms MalignantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council
- Responsible party
- Sponsor
- Investigators
- Shih-hsin Chen, MD PhD, Principal investigator, Chang Gung Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157463
- Sponsor's protocol ID
- 202202030A0C601
- Status last verified
- Mar 2026
- First submitted
- 27 Nov 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will only be shared with co-investigators listed in the IRB application to protect the participants' privacy.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 68Ga FAPI in Total Neoadjuvant Therapy of Rectal Cancer
- ClinicalTrials.gov ID
- NCT06157463
- Acronym / sponsor ID
- 202202030A0C601
- Conditions
- Rectal Neoplasms Malignant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council
- Study start
- 8 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | Radiation: Ga-68 FAPIGa-68 FAPI study before and during TNT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Those patient referred to the tertiary medical center for rectal cancer will be invited to enroll in the study.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga-68 FAPIFAPI PET scans will be performed in addition to other staging/restaging work-up | Radiation | observation |
Primary outcome
Change of FAPI SUV
Time frame: before TNT & 22-24wk into TNT
To compare the FAPI uptake after TNT
1 secondary outcome
Correlation of FAPI SUV
Time frame: 2 years after recruitment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No. IPD will only be shared with co-investigators listed in the IRB application to protect the participants' privacy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shih-hsin Chen, MD PhD principal investigator
Chang Gung Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Neoplasms Malignant, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shih-hsin Chen, MD PhD (886-3-3281200 ext. 3565, yevgenyc@cgmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of FAPI SUV (time frame: before TNT & 22-24wk into TNT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.