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

2023-09-01

2024-06-30

2025-06-30

29

Study Overview

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

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.

  • Advanced Pancreatic Cancer and Cholangiocarcinoma
  • DRUG: PRRT with 177Lu-EB-FAPI
  • CISPD-5

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2023-06-12  

N/A  

2023-10-10  

2023-10-10  

N/A  

2023-10-13  

2023-10-13  

N/A  

2023-06  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Phase Ia: Dose escalation

To determine the therapeutic dose of 177Lu-EB-FAPI using a 3 + 3 dose-escalation mode

DRUG: PRRT with 177Lu-EB-FAPI

  • PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue
EXPERIMENTAL: Phase Ib: Dose expansion-pancreatic cancer cohort

In pancreatic cancer cohort, patients will receive the first phase determined dose of 177Lu-EB-FAPI every 4 weeks, and each patient will receive no more than 4 cycles.

DRUG: PRRT with 177Lu-EB-FAPI

  • PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue
EXPERIMENTAL: Phase Ib: Dose expansion-cholangiocarcinoma cohort

In cholangiocarcinoma cohort, patients will receive the first phase determined dose of 177Lu-EB-FAPI every 4 weeks, and each patient will receive no more than 4 cycles.

DRUG: PRRT with 177Lu-EB-FAPI

  • PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue
Primary Outcome MeasuresMeasure DescriptionTime Frame
Safety of treatment：hematotoxicitySafety evaluation，Complete Blood Count was done continuously during treatment by using CTCAE 5.0 during studyUp to 2 years.
Objective reponse rate (ORR)The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase IbUp to 2 years
Safety of treatment：HepatotoxicitySafety 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.Up to 2 years.
Safety of treatment：renal toxicitySafety 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.Up to 2 years.
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Disease control rate (DCR)The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during phase IbUp 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 IbUp to 2 years
Progression-free survival （PFS）The time from enrolled to disease pregression or death from any cause during phase IbUp to 2 years
Overall survival (OS)The time from enrolled to death from any cause during phase IbUp to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Tingbo Liang, PhD

Phone Number: +86 19941463683

Email: liangtingbo@zju.edu.cn

Study Contact Backup

Name: Yiwen Chen, MD

Phone Number: +86 15088682641

Email: cherry0705@zju.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts 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; 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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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