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Pancreatic Ductal Adenocarcinoma (PDAC)NCT07014254

Therapeutic Study of 177Lu-CTR-FAPI in Advanced Metastatic Digestive Malignancies

A study testing 177Lu-CTR-FAPI nuclide-targeted therapy in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Adenocarcinoma of the Stomach, run by Xijing Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This was a single-centre, single-arm, non-blinded, prospective study using 20 patients with advanced metastatic GI malignancies recruited to treat patients with advanced metastatic GI malignancies with 177Lu-CTR-FAPI to assess the safety of 177Lu-CTR-FAPI in advanced metastatic GI malignancies; this included radiation… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
177Lu-CTR-FAPI nuclide-targeted therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
20 Jun 2025to 30 Apr 2028
Phase
Interventional
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. voluntary participation in this study and signing of informed consent;
  • 2. age 18-75 years (both 18 and 75 years);
  • 3. ECOG (Eastern Cooperative Oncology Group) physical status score: 0-1;
  • 4.Advanced metastatic gastrointestinal malignancies with high FAP expression: e.g. neuroendocrine tumours (NET G2, G3), neuroendocrine carcinomas (NEC), pancreatic ductal adenocarcinomas (PDAC), gastric adenocarcinomas, colorectal carcinomas, intrahepatic cholangiocarcinomas (ICC), and squamous carcinomas of the oesophagus. All of the above should be confirmed by 68Ga-FAPI PET/CT with high FAP expression (criterion: more than 50% of lesions with SUVmax ≥10). 5.
  • 5. Disease status: locally advanced unresectable or metastatic lesions confirmed by imaging (CT/MRI/PET-CT); at least 1 measurable lesion (RECIST 1.1 criteria).
  • 6. good major organ function, i.e. the following criteria are met (no blood components, cell growth factors are allowed within 14 days prior to the first dose)
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  • Creatinine clearance ≥ 50 ml/min (calculated according to the Cockcroft-Gault formula) or serum creatinine ≤ 150 μmol/L;
  • Urine protein <2+; if urine protein ≥2+, then 24-hour urine protein quantification must show <2 g of protein;
  • White blood cell count ≥ 2 × 109/L;
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L;
  • Platelets ≥ 75 × 109/L;
  • Haemoglobin ≥ 8.0 g/dL;
  • Serum albumin ≥ 30 g/L.
  • Total bilirubin ≤ 3 × ULN;
  • 7. Women of childbearing age who undergo a blood pregnancy test within 72 h prior to treatment need to be excluded from pregnancy and must be non-lactating and willing to use a highly effective method of contraception for the duration of the trial and for 6 months after completion of treatment. For men, agreement to use a highly effective method of contraception or to have been surgically sterilised during the study and for 4 months after the end of treatment.

Who cannot join

  • 1. Disease-related:
  • Combination of other malignancies (except non-melanoma skin cancer or radical tumours without recurrence within 5 years);
  • Presence of central nervous system metastases or carcinomatous meningitis;
  • Uncontrolled cancer pain (requiring long-term high-dose opioids) or cachexia (≥20% weight loss in 6 months);
  • Diabetes mellitus (fasting blood glucose > 2 x ULN) that is not well controlled with optimal medical supportive therapy;
  • Accompanied by poorly controlled plasmapheresis, including pleural fluid, ascites, and pericardial effusion; controlled with treatment and stable (asymptomatic, not requiring interventional therapy, and stable on imaging) for ≥2 weeks may be included;
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  • Severe urinary incontinence, hydronephrosis, severe voiding dysfunction or the need for an indwelling urinary catheter for any reason;
  • Subjects with uncontrolled cardiac clinical symptoms or disease, including but not limited to: i) NYHA class 2 or higher heart failure; ii) unstable angina; iii) myocardial infarction within 1 year prior to enrolment; iv) left ventricular ejection fraction (LVEF) <50%; v) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
  • Co-occurring active hepatitis B (HBV-DNA testing is required for HBsAg-positive individuals with HBV DNA ≥500 IU/mL or 2500 copies/mL), and hepatitis C (HCV-Ab-positive and above the lower limit of detection of the analytical method);
  • Persons known to have acquired immunodeficiency syndrome (AIDS) or human immunodeficiency virus (HIV) testing positive. Persons with active syphilis infection.
  • 2. Treatment related
  • Radiotherapy within 4 weeks or previous radiotherapy to >25% of the bone marrow area;
  • Received systemic anti-tumour therapy such as chemotherapy, immunotherapy, targeted therapy within 4 weeks;
  • Treatment with surgery (biopsy puncture, non-anti-tumour surgical operations such as ERCP may be excluded), radiofrequency ablation or cryoablation, interferon, transcatheter arterial embolisation (TAE) or transcatheter arterial chemoembolisation (TACE) within 12 weeks;
  • Prior FAP-targeted therapy (e.g., FAPI-PRRT, anti-FAP antibody drugs);
  • Presence of contraindications to radionuclide therapy (e.g., myelodysplastic syndrome, extensive bone metastases with bone marrow failure).
  • Comorbidities and Risks:
  • Previous antineoplastic therapy resulting in toxicity that has not recovered to grade ≤1 according to the NCI-CTCAE v5.0 classification (with the exception of lowered lymphocyte counts, alopecia, and the indicators mentioned in the inclusion criteria, and with the exception of partially tolerable chronic grade 2 toxicity, in the judgement of the investigator).
  • 3. Other exclusions
  • History of allergy to peptide radiopharmaceuticals;
  • Inability to co-operate with long-term follow-up (e.g., mental illness, geographical constraints, etc.);
  • Refusal of contraception by pregnant or lactating women or patients of childbearing age.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ying Guo Ying Guo contact

+862984771048

guoying01192022@163.com

China1 site

  • Department of Nuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China, Xi'an, Shaanxi Province Recruiting

    Xi'an, Shaanxi

    Ying Guo Ying Guo, +862984771048, guoying01192022@163.com

Other trials in China

About this study

Official title: Therapeutic Study of 177Lu-CTR-FAPI-targeted Nuclear Drugs in Advanced Metastatic Digestive Malignancies

This was a single-centre, single-arm, non-blinded, prospective study using 20 patients with advanced metastatic GI malignancies recruited to treat patients with advanced metastatic GI malignancies with 177Lu-CTR-FAPI to assess the safety of 177Lu-CTR-FAPI in advanced metastatic GI malignancies; this included radiation therapy dosimetry and initial treatment Determination of Effectiveness

Being tested
177Lu-CTR-FAPI nuclide-targeted therapy
Keywords
177Lu-CTR-FAPI
Medical subject headings
Neuroendocrine Tumors

What participants receive

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

  • 177Lu-CTR-FAPI nuclide-targeted therapyDrug

    Fasting, special diets, or other specific preparations are not required on the day of 177Lu-CTR-FAPI administration. Patients were given 4 mg ondansetron 30 minutes before treatment to prevent nausea and vomiting. The radiopharmaceutical 177Lu-CTR-FAPI (200 ± 10% mCi) was diluted with 100 mL of 0.9% saline and given slowly by intravenous infusion over 20-30 minutes (flow rate 200 ml/h). Symptoms and vital signs were monitored before and after treatment. The treatment regimen was planned for a maximum of 3 courses of treatment, with 4-8 weeks between each cycle

Study groups in NCT07014254
Study groupRoleWhat they receive
177Lu-CTR-FAPI nuclide-targeted therapyExperimental177Lu-CTR-FAPI nuclide-targeted therapy in patients with advanced tumours lacking effective treatments
Receives: Drug: 177Lu-CTR-FAPI nuclide-targeted therapy

What is being measured

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

  1. ORR

    Objective mitigation rate

    Measured: End of treatment (12 weeks)

  2. DCR

    Disease control rate

    Measured: End of treatment (12 weeks)

Timeline

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

  1. First posted10 Jun 2025
  2. Study start20 Jun 2025 (estimated)
  3. Primary completion30 Apr 2028 (estimated)
  4. Study completion30 Apr 2028 (estimated)

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07014254
Sponsor's protocol ID
KY20252131-C-1
Status last verified
May 2025
First submitted
22 May 2025
Last updated
10 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 177Lu-CTR-FAPI nuclide-targeted therapy in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Adenocarcinoma of the Stomach, run by Xijing Hospital 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 15 inclusion and 22 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: opening soon, as of the sponsor's last update on 10 Jun 2025. 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.

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 Ying Guo Ying Guo (+862984771048, guoying01192022@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: End of treatment (12 weeks)). The study lists 2 primary outcomes in all. 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 NCT07014254.

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 10 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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