A Study to Evaluate the Safety and Efficacy of PRRT With 177Lu-EB-FAPI in Patients With Advanced Cholopancreatic Tumors

Inclusion Criteria:

1. Signed the informed consent form;
2. Age: 18-75 years old (when signing the informed consent form);
3. Received 68 Ga-FAPI 46 PET imaging positive before treatment;
4. Phase Ia requires patients who have previously failed at least 2 lines of systemic chemotherapy or who the investigator considers unsuitable to receive systemic chemotherapy; Phase Ib Cohort 1, enrollment of patients with hist-or cytologically confirmed metastatic pancreatic cancer; Phase Ib Cohort 2, enrollment of patients with hist-or cytologically confirmed metastatic cholangiocarcinoma;
5. Phase Ia requires at least one evaluable lesion confirmed per RECIST 1.1 criteria; Phase Ib requires at least one measurable lesion confirmed per RECIST 1.1 criteria;
6. ECOG score 0-1, expected survival greater than 3 months;
7. Major organs function well;
8. Patients must have reliable contraception during the study and within 6 months after the study period; negative serum pregnancy / urine pregnancy test within 7 days before study enrollment and must be non-lactating subjects; male subjects should agree to have contraception during the study and within 6 months after the end of the study period.

Exclusion Criteria:

1. Prior treatment before the first dose included chemotherapy and targeted therapy with any associated toxicity (CTCAE v5.0) of\> 1 N. A., excluding alopecia;
2. Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
3. Within 5 years, the patient had previous or both other malignant tumors (except for cured skin basal cell carcinoma and cervical carcinoma in situ); had other malignant tumors, but the following two conditions can be enrolled: other malignant tumors treated with single surgery with R0 resection and no recurrence and metastasis; cured cervical carcinoma in situ, skin basal cell carcinoma, nasopharyngeal carcinoma and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
4. Major surgical treatment with significant traumatic injury within 28 days prior to the first medication;
5. Long-term non-healed wound or fracture; Active bleeding or high risk of bleeding considered by the investigator, such as gastric fundus varices, hemoptysis, etc.;
6. Motor / venous thrombosis events, such as cerebrovascular accidents (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before the first medication;
7. Patients with a history of psychiatric substance abuse and unable to quit or with mental disorders;
8. Symptomatic interstitial lung disease, and conditions that may cause drug pulmonary toxicity or associated pneumonia;
9. Patients with any severe and / or uncontrolled disease.
10. Previous history of severe allergy to macromolecular drugs, or allergy to the known component of 177Lu-EB-FAPI injection;
11. Claustrophobic or radiologically phobic patients, or patients with mental disorders or primary affective disorders;
12. According to the discretion of the investigator, subjects with a serious hazard to subject safety or concomitant illness affecting the study or other reasons for enrollment.