New scan may tell rectal cancer patients if they can skip surgery
NCT ID NCT06608537
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed phase 2 study tested whether a new type of PET scan (FAPI-PET/CT) can accurately predict if rectal cancer has completely disappeared after a combination of short-course radiation, immunotherapy, and chemotherapy. Fifty-two patients with locally advanced rectal cancer received the treatment and then underwent both standard FDG-PET and FAPI-PET scans before surgery. The goal was to see if the FAPI scan could reliably identify patients who achieved a pathological complete response, potentially allowing them to avoid surgery and preserve their rectum.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 18F-FAPI-42 radiotracer (for PET/CT imaging)
- What this could lead to
- If successful, this imaging method could help doctors accurately identify which rectal cancer patients have a complete response to treatment, allowing more patients to avoid surgery and preserve their rectum.
- What could go wrong
- This is a small, single-center phase 2 study with only 52 participants, so results may not apply to all patients. The imaging technique is still experimental and not yet standard practice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
52 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
-
Dec 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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; * 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. Exclusion Criteria: * 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 \&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); * 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 \&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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Rectal adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New injectable drug tested against Hard-to-Treat solid tumors
- Robotic surgery vs standard approaches: does the platform change cancer outcomes?
- Could a nasal tube replace a temporary ileostomy after rectal cancer surgery?
- Blood test aims to catch Cancer's return earlier
- Blood test guides immunotherapy for hidden cancer cells
- Can two immunotherapy drugs help rectal cancer patients skip pelvic radiation?