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

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

An Exploratory Study to Evaluate the Safety and Efficacy of Peptide Receptor Radionuclide Therapy With 177Lu-EB-FAPI in Patients With Advanced Cholopancreatic Tumors

NCT06081322•Zhejiang University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

Locations (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, China

Key Dates

Start Date

September 1, 2023

Primary Completion Date

June 30, 2024

Completion Date

June 30, 2025

Last Updated

October 13, 2023

Enrollment

ESTIMATED participants

Conditions

Advanced Pancreatic Cancer and Cholangiocarcinoma

Interventions

PRRT with 177Lu-EB-FAPI

DRUG

Contacts

Tingbo Liang, PhD

CONTACT

+86 19941463683 liangtingbo@zju.edu.cn

Yiwen Chen, MD

CONTACT

+86 15088682641 cherry0705@zju.edu.cn