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

NCT07014254 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-06-10

No results posted yet for this study

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 therapy dosimetry and initial treatment Determination of Effectiveness

Conditions

  • Pancreatic Ductal Adenocarcinoma (PDAC)
  • Adenocarcinoma of the Stomach
  • Colorectal Cancer Metastatic
  • Neuroendocrine Tumor (NET)

Interventions

DRUG

177Lu-CTR-FAPI nuclide-targeted therapy

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

Sponsors & Collaborators

  • Xijing Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-20
Primary Completion
2028-04-30
Completion
2028-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07014254 on ClinicalTrials.gov