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Trial Title:
A Study to Evaluate the Safety and Efficacy of PRRT With 177Lu-EB-FAPI in Patients With Advanced Cholopancreatic Tumors
NCT ID:
NCT06081322
Condition:
Advanced Pancreatic Cancer and Cholangiocarcinoma
Conditions: Official terms:
Cholangiocarcinoma
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PRRT with 177Lu-EB-FAPI
Description:
PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue
Arm group label:
Phase Ia: Dose escalation
Arm group label:
Phase Ib: Dose expansion-cholangiocarcinoma cohort
Arm group label:
Phase Ib: Dose expansion-pancreatic cancer cohort
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:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Zhejiang University
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Yiwen Chen, MD
Phone:
19941463683
Start date:
September 1, 2023
Completion date:
June 30, 2025
Lead sponsor:
Agency:
Zhejiang University
Agency class:
Other
Source:
Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06081322
