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

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

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-80

SponsorXijing Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Sequential

Treatments tested in this trial

177Lu-CTR-FAPI nuclide-targeted therapy
Drug
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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: 177Lu-CTR-FAPI nuclide-targeted therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

ORR

Objective mitigation rate

Time frame

End of treatment (12 weeks)

DCR

Disease control rate

Time frame

End of treatment (12 weeks)

Sponsors and contacts

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Xijing Hospital

Lead sponsor

Source ClinicalTrials.gov

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