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Radioactive injection targets Hard-to-Treat pancreatic tumors

NCT ID NCT07229768

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial is testing a radioactive drug called 177Lu-CTR-FAPI in 4 people with advanced pancreatic cancer that has not responded to standard treatments. The drug is given intravenously every 6 weeks for up to 4 doses. Researchers are checking for safety, how much radiation reaches organs, and whether tumors shrink.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
177Lu-CTR-FAPI injection (a radioactive drug that targets tumors)
What this could lead to
If it works, this could point toward a new treatment option for advanced pancreatic cancer that has stopped responding to standard therapies.
What could go wrong
This is a very early, small trial with only 4 participants, so results may not apply broadly. The radioactive drug may cause side effects or not shrink tumors effectively.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 4 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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 85 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 1: Patients with unresectable, advanced, or metastatic solid tumors who have been histologically or cytologically confirmed, have failed standard treatment, lack standard treatment options, or refuse standard treatment. Preferred tumor types include pancreatic cancer, breast cancer, and soft tissue sarcoma, and must meet any of the following tumor-specific criteria: 1. Patients with advanced or metastatic TNBC who have progressed after or are intolerant to at least 2 lines of systemic therapy; 2. Patients with HER2-positive advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of HER2-targeted therapy; 3. Patients with HR/HER2-negative advanced or metastatic breast cancer who have progressed after or are intolerant to at least 2 lines of systemic therapy; 4. Patients with advanced or metastatic high-grade soft tissue sarcoma (excluding chordoma) who have progressed after or are intolerant to at least 1 line of systemic therapy; 5. Patients with advanced or metastatic pancreatic cancer who have progressed after or are intolerant to at least 1 line of systemic therapy. * 2: Age \>= 18 years, regardless of sex; * 3: Able to understand and sign informed consent and willing and able to comply with study and follow-up procedures; * 4: ECOG performance status score of 0 or 1; * 5: FAP expression in tumor lesions confirmed positive by FAPI PET/CT; * 6: Agree to provide archived or fresh tumor tissue for immunohistochemical evaluation (if available); * 7: At least 1 measurable lesion according to RECIST 1.1 criteria; * 8: Previous anti-tumor toxicities recovered to grade 0-1; * 9: Organ function meets requirements before first administration; 1. Hematology: Absolute neutrophil count (ANC) \>= 1.5×10\^9/L; Hemoglobin (Hb) \>= 80 g/L; Platelet count (PLT) \>= 75×10\^9/L; 2. Liver function: Total bilirubin (TB) \<= 1.5×ULN; AST and ALT \<= 3×ULN, and if there is hepatic tumor metastasis, ALT and AST \<= 5×ULN; 3. Renal function: Creatinine clearance \>= 50 mL/min (Cockcroft-Gault formula); ECG: QTcF \<= 470 ms; * 10: Fertile subjects voluntarily use effective contraception during treatment and for 4 months (male) or 7 months (female) after the last dose of study drug. Exclusion Criteria: * 1: Subjects with brain metastases, meningiomas, or other central nervous system lesions at screening * 2: Severe allergy to contrast agents or claustrophobia * 3: Expected survival period \< 6 months * 4: Receipt of blood transfusion within 2 weeks before the first dose to meet the eligibility criteria * 5: Administration of systemic antitumor therapies (including targeted therapy, immunotherapy, traditional Chinese medicine antitumor treatment, chemotherapy, etc.) within 4 weeks prior to the first dose * 6: Participation in other clinical trials involving investigational drugs or devices within 4 weeks before the first dose * 7: Major surgery within 4 weeks before the first dose or planned major surgery during the study period * 8: Active bacterial, fungal, viral, or other infections requiring intravenous medication within 4 weeks before the first dose * 9: Previous systemic radionuclide therapy (excluding I-131 treatment for thyroid cancer) or external beam radiotherapy (EBRT) within 4 weeks prior to the first dose * 10: History of other malignancies within 5 years before the first dose * 11: Severe cardiovascular or cerebrovascular diseases, or poorly controlled diabetes * 12: Presence of pleural effusion or ascites requiring treatment or judged by the investigator as uncontrolled at screening * 13: Females who are pregnant or breastfeeding * 14: Subjects considered by the investigator to have poor compliance and inability to cooperate with treatment and follow-up at screening.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General Hospital

    RECRUITING

    Shanghai, China

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