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AzTrials

Rectal CancerPhase 2NCT06608537

A Clinical Study Based on FAPI-PET/CT Technology to Predict Pathological Complete Response After Neoadjuvant Chemoradiotherapy for MSS Rectal Cancer

A Phase 2 study testing neoadjuvant SCRT followed by Sintilimab plus CAPOX in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The combination of short course radiotherapy and immunotherapy helps to increase the proportion of pathological complete response after neoadjuvant therapy, providing more patients with the opportunity for organ preservation. However, there is no accurate and unified cCR diagnostic standard in the world. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Rectal Cancer
What is being tested?
neoadjuvant SCRT followed by Sintilimab plus CAPOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
1 Dec 2024to 30 Dec 2025
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • With my consent and signed informed consent, willing and able to comply with the planned visit, research treatment, laboratory tests and other test procedures;
  • Age 18-75;
  • Patients with a pathologically or cytologically confirmed adenocarcinoma of the rectum, all other histological types excluded;
  • The distance between the lower margin of the rectal tumor lesion and the anal margin <12cm;
  • The physical status score (ECOG) of the Eastern United States Cancer Cooperative Group was 0-1 ;
  • T3-4/N+ was evaluated by pelvic enhanced MRI;
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  • Had not received systemic anti-tumor therapy for colon cancer, including cytotoxic drugs, immune checkpoint inhibitor therapy, molecular targeted therapy, endocrine therapy, etc.;
  • Appropriate organ function based on the following laboratory test values obtained during the screening period: White blood cell count ≥3×109/L, neutrophil count ≥1.5×109 /L, platelet count ≥75×109 /L, serum total bilirubin ≤ 1.5× upper limit of normal (UNL), AST (SGOT) or ALT (SGPT) ≤ 2.5×UNL, serum creatinine ≤ 1.5×UNL;
  • Female subjects of reproductive age must undergo a negative serum pregnancy test within 3 days prior to the start of the study drug and be willing to use a medically approved highly effective contraceptive method (such as an IUD, contraceptive pill, or condom) during the study period and within 3 months after the last study drug administration; Male subjects whose partners are women of reproductive age should be surgically sterilized or agree to use effective contraception during the study period and for 3 months after the last study dosing;
  • Willing and able to comply with research procedures and visit plans.

Who cannot join

  • Whole-body CT, MR, or PET-CT (including at least the chest, whole abdomen, and pelvis) confirms distant metastases (M1);
  • Patients with complete intestinal obstruction, active bleeding or perforation requiring emergency surgery;
  • The presence of other active malignancies in the past or at the same time (except malignancies that have received curative treatment and have been free of disease for more than 5 years or cancers in situ that can be cured by adequate treatment);
  • Thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, and deep vein thrombosis, occurred in the 12 months prior to study entry;
  • Myocardial infarction, severe/unstable angina pectoris, NYHA grade 2 or higher cardiac dysfunction, clinically significant supracentricular or ventricular arrhythmia, and symptomatic congestive heart failure in the 12 months prior to enrollment;
  • Systemic antibiotic use ≥ 7 days within 4 weeks prior to enrollment, or unexplained fever \&amp;gt during screening/prior to first dosing; 38.5°C (as determined by the investigators, fever due to tumor could be included); Had received major operations such as laparotomy, thoracotomy, laparoscopic resection of organs or severe trauma within 2 months before enrollment (the surgical incision should be completely healed before enrollment in this clinical trial);
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  • Known presence of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related disease;
  • The presence of interstitial lung disease, non-infectious pneumonia or uncontrolled systemic diseases (such as diabetes, hypertension, pulmonary fibrosis and acute pneumonia); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU/ml; Hepatitis C, defined as HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C;
  • A known or suspected history of allergy to any of the relevant drugs used in the study;
  • Pregnant or lactating women; Women of reproductive age who do not use or refuse to use effective non-hormonal contraception (after the last menstrual period \&amp;lt; 2 years) or men who are likely to have children;
  • The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the study or interfere with the study results, as well as patients deemed unsuitable for participation in this study by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: A Single-center, Single-arm Phase II Clinical Study Based on FAPI-PET/CT Technology to Predict Pathological Complete Response After Neoadjuvant Chemoradiotherapy for MSS Rectal Cancer

The combination of short course radiotherapy and immunotherapy helps to increase the proportion of pathological complete response after neoadjuvant therapy, providing more patients with the opportunity for organ preservation. However, there is no accurate and unified cCR diagnostic standard in the world. As a new radiotracer, 18F-FAPI has been developed and used to target fibroblast activating protein and tumor matrix visualization, which has the advantages of low background uptake, high contrast, few preparation requirements, short post-injection interval, and no influence on blood glucose. Therefore, we will invite you to participate in a clinical study to explore whether the PET parameters of 18F-FDG and 18F-FAPI-42 PET/CT can be used to predict pathological responses after neoadjuvant therapy for locally advanced rectal cancer (LARC). The findings will help improve future treatment stratification of LARC, help patients preserve organs and improve quality of life.

Conditions
Rectal Cancer
Being tested
neoadjuvant SCRT followed by Sintilimab plus CAPOX
Keywords
FAPI, PET/CT, PD-1, neoadjuvant chemoradiotherapy
Medical subject headings
Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • neoadjuvant SCRT followed by Sintilimab plus CAPOXDrug

    Patientsreceived neoadjuvant treatment consisting of SCRT (a total of 25 Gy in 5 days) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later.

Study groups in NCT06608537
Study groupRoleWhat they receive
neoadjuvant SCRT followed by Sintilimab plus CAPOXExperimentalPatients received neoadjuvant treatment consisting of SCRT (a total of 25 Gy in 5 days) followed by sintilimab (3mg/kg intravenous drip on day 1; every 3-week cycle for two cycles) combined with CAPOX (oxaliplatin 130 mg/m2 intravenous infusion over 2 h on day 1, capecitabine 1000 mg/m2 orally twice daily from day 1-14, in every 3-week cycle for two cycles) 1 week later.
Receives: Drug: neoadjuvant SCRT followed by Sintilimab plus CAPOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pathological complete response (pCR) prediction accuracy

    PCR prediction accuracy was defined as the ratio at which 18F-FAPI-42 combined with 18F-FDG PET/CT predicted results in agreement with post-operative pathologic diagnoses.

    Measured: 3 months

Secondary outcomes (1)

  1. Prediction accuracy of non-pathological complete response (npCR)

    The prediction accuracy of nPCR was defined as the ratio at which 18F-FAPI-42 combined with 18F-FDG PET/CT and histopathological profiling predicted nPCR to be consistent with post-operative pathological diagnosis

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start1 Dec 2024
  3. Primary completion30 Jul 2025
  4. Study completion30 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06608537
Sponsor's protocol ID
GIHSYSU-FAPI01
Status last verified
Jul 2025
First submitted
19 Sep 2024
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • He M, Yang H, Shi Y, Zhang R, Wan T, Pang X, Zhang Z, Huang L. Integrated Multi-Time-Point 18F-FAPI PET/CT and Immune Histopathology for Predicting Pathological Complete Response in Microsatellite-Stable Locally Advanced Rectal Cancer Treated With Neoadjuvant Radiotherapy, Chemotherapy, and Immunotherapy. MedComm (2020). 2026 Oct 13;7(10):e71072. doi: 10.1002/mco2.71072. eCollection 2026 Oct.

    PubMed 42872124

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing neoadjuvant SCRT followed by Sintilimab plus CAPOX in people with Rectal Cancer, run by Sun Yat-sen University at 1 site in China.

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 10 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: finished, as of the sponsor's last update on 4 Mar 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 China. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological complete response (pCR) prediction accuracy (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06608537, which also lists 1 linked publication.

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 4 Mar 2026.

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