This study is a prospective, single-center, open, single-arm, exploratory study to evaluate the safety and efficacy of 177Lu-EB-FAPI PRRT, and to explore 177Lu-EB-FAPI in patients with advanced pancreatic cancer and cholangiocarcinoma. Eligible patients with advanced pancreatic cancer or cholangiocarcinoma were screened and enrolled after signing the informed consent forms. In the first stage of the enrolled patients, the 177Lu-EB-FAPI treatment dose was determined using a 3 + 3 dose escalation mode. Patients enrolled in the second phase, divided into pancreatic cancer cohort and cholangiocarcinoma based on pathology, will receive the first phase determined dose of 177Lu-EB-FAPI every 4 weeks, and each patient will receive no more than 4 cycles. The aim of the study is to evaluate the safety and efficacy of the 177Lu-EB-FAPI treatment.
This study is a prospective, single-center, open, single-arm, exploratory study to evaluate the safety and efficacy of 177Lu-EB-FAPI PRRT, and to explore 177Lu-EB-FAPI in patients with advanced pancreatic cancer and cholangiocarcinoma. Eligible patients with advanced pancreatic cancer or cholangiocarcinoma were screened and enrolled after signing the informed consent forms. In the first stage of the enrolled patients, the 177Lu-EB-FAPI treatment dose was determined using a 3 + 3 dose escalation mode. Patients enrolled in the second phase, divided into pancreatic cancer cohort and cholangiocarcinoma based on pathology, will receive the first phase determined dose of 177Lu-EB-FAPI every 4 weeks, and each patient will receive no more than 4 cycles. The aim of the study is to evaluate the safety and efficacy of the 177Lu-EB-FAPI treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGSafety of treatment:hematotoxicity
Safety evaluation,Complete Blood Count was done continuously during treatment by using CTCAE 5.0 during study
Time frame: Up to 2 years.
Objective reponse rate (ORR)
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase Ib
Time frame: Up to 2 years
Safety of treatment:Hepatotoxicity
Safety evaluation,liver function lab test was done continuously during treatment and the level of serum ALT, AST, and total bilirubin will be evaluated by using CTCAE 5.0 during study.
Time frame: Up to 2 years.
Safety of treatment:renal toxicity
Safety evaluation,renal function lab test was done continuously during treatment and the level of serum creatinine will be evaluated by using CTCAE 5.0 during study.
Time frame: Up to 2 years.
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during phase Ib
Time frame: Up to 2 years
Duration of remission (DoR)
The time from the first assessment of the tumor as CR or PR to the first assessment of PD or death from any cause during phase Ib
Time frame: Up to 2 years
Progression-free survival (PFS)
The time from enrolled to disease pregression or death from any cause during phase Ib
Time frame: Up to 2 years
Overall survival (OS)
The time from enrolled to death from any cause during phase Ib
Time frame: Up to 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.