Advanced Pancreatic Cancer and CholangiocarcinomaPhase 1CISPD-5NCT06081322
A Study to Evaluate the Safety and Efficacy of PRRT With 177Lu-EB-FAPI in Patients With Advanced Cholopancreatic Tumors
A Phase 1 study testing PRRT with 177Lu-EB-FAPI in people with Advanced Pancreatic Cancer and Cholangiocarcinoma, run by Zhejiang University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Pancreatic Cancer and Cholangiocarcinoma
- What is being tested?
- PRRT with 177Lu-EB-FAPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed the informed consent form;
- Age: 18-75 years old (when signing the informed consent form);
- Received 68 Ga-FAPI 46 PET imaging positive before treatment;
- 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;
- 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;
- ECOG score 0-1, expected survival greater than 3 months;
- Major organs function well;
- 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.
Who cannot join
- Prior treatment before the first dose included chemotherapy and targeted therapy with any associated toxicity (CTCAE v5.0) of> 1 N. A., excluding alopecia;
- Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
- 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)];
- Major surgical treatment with significant traumatic injury within 28 days prior to the first medication;
- 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.;
- 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;
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- Patients with a history of psychiatric substance abuse and unable to quit or with mental disorders;
- Symptomatic interstitial lung disease, and conditions that may cause drug pulmonary toxicity or associated pneumonia;
- Patients with any severe and / or uncontrolled disease.
- Previous history of severe allergy to macromolecular drugs, or allergy to the known component of 177Lu-EB-FAPI injection;
- Claustrophobic or radiologically phobic patients, or patients with mental disorders or primary affective disorders;
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
Yiwen Chen, MD, 19941463683
About this study
Official title: An Exploratory Study to Evaluate the Safety and Efficacy of Peptide Receptor Radionuclide Therapy 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.
Read the 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.
- Being tested
- PRRT with 177Lu-EB-FAPI
- Medical subject headings
- Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRRT with 177Lu-EB-FAPIDrug
PRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue
| Study group | Role | What they receive |
|---|---|---|
| Phase Ia: Dose escalation | Experimental | To determine the therapeutic dose of 177Lu-EB-FAPI using a 3 + 3 dose-escalation mode Receives: Drug: PRRT with 177Lu-EB-FAPI |
| Phase Ib: Dose expansion-pancreatic cancer cohort | Experimental | 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. Receives: Drug: PRRT with 177Lu-EB-FAPI |
| Phase Ib: Dose expansion-cholangiocarcinoma cohort | Experimental | 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. Receives: Drug: PRRT with 177Lu-EB-FAPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of treatment：hematotoxicity
Safety evaluation，Complete Blood Count was done continuously during treatment by using CTCAE 5.0 during study
Measured: 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
Measured: 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.
Measured: 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.
Measured: Up to 2 years.
Secondary outcomes (4)
Disease control rate (DCR)
The proportion of patients who had tumor evaluated as PR or SD according to RECIST1.1 criteria during phase Ib
Measured: 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
Measured: Up to 2 years
Progression-free survival （PFS）
The time from enrolled to disease pregression or death from any cause during phase Ib
Measured: Up to 2 years
Overall survival (OS)
The time from enrolled to death from any cause during phase Ib
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start1 Sep 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Pancreatic Cancer and CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TingBo Liang, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081322
- Sponsor's protocol ID
- CISPD-5
- Acronym
- CISPD-5
- Status last verified
- Jun 2023
- First submitted
- 12 Jun 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study to Evaluate the Safety and Efficacy of Peptide Receptor Radionuclide Therapy With 177Lu-EB-FAPI in Patients With Advanced Cholopancreatic Tumors
- ClinicalTrials.gov ID
- NCT06081322
- Acronym / sponsor ID
- CISPD-5 / CISPD-5
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase Ia: Dose escalation | Experimental | Drug: PRRT with 177Lu-EB-FAPITo determine the therapeutic dose of 177Lu-EB-FAPI using a 3 + 3 dose-escalation mode |
| Phase Ib: Dose expansion-pancreatic cancer cohort | Experimental | Drug: PRRT with 177Lu-EB-FAPIIn 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. |
| Phase Ib: Dose expansion-cholangiocarcinoma cohort | Experimental | Drug: PRRT with 177Lu-EB-FAPIIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed the informed consent form;
- Age: 18-75 years old (when signing the informed consent form);
- Received 68 Ga-FAPI 46 PET imaging positive before treatment;
- 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;
- 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;
Key exclusion criteria (12 listed)
- Prior treatment before the first dose included chemotherapy and targeted therapy with any associated toxicity (CTCAE v5.0) of> 1 N. A., excluding alopecia;
- Severe organ failure, such as respiratory failure, uncontrolled thyroid dysfunction including hyperthyroidism and hypothyroidism, or uncorrection of K +, Na +, Ca 2 + electrolyte disorders;
- 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)];
- Major surgical treatment with significant traumatic injury within 28 days prior to the first medication;
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRRT with 177Lu-EB-FAPIPRRT with 177Lu-Fibroblast activation protein inhibitor and modified by Evans blue | Drug | Phase Ia: Dose escalation, Phase Ib: Dose expansion-cholangiocarcinoma cohort, Phase Ib: Dose expansion-pancreatic cancer cohort |
Primary outcome
Safety of treatment：hematotoxicity
Time frame: Up to 2 years.
Safety evaluation，Complete Blood Count was done continuously during treatment by using CTCAE 5.0 during study
Objective reponse rate (ORR)
Time frame: Up to 2 years
The proportion of patients who had tumor evaluated as PR according to RECIST1.1 criteria during phase Ib
Safety of treatment：Hepatotoxicity
Time frame: Up to 2 years.
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.
Safety of treatment：renal toxicity
Time frame: Up to 2 years.
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.
4 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of remission （DoR）
Time frame: Up to 2 years
Progression-free survival （PFS）
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRRT with 177Lu-EB-FAPI in people with Advanced Pancreatic Cancer and Cholangiocarcinoma, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingbo Liang, PhD (+86 19941463683, liangtingbo@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of treatment：hematotoxicity (time frame: Up to 2 years.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.