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
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
Treatments tested in this trial
- 177Lu-CTR-FAPI nuclide-targeted therapy