Evaluating a new treatment for advanced pancreatic cancer and cholangiocarcinoma

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 testing a new treatment for advanced pancreatic cancer and cholangiocarcinoma to see if it is safe and effective for patients.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Zhejiang University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06081322 on ClinicalTrials.gov

What this trial studies

This study is an exploratory, single-center trial assessing the safety and efficacy of 177Lu-EB-FAPI peptide receptor radionuclide therapy (PRRT) in patients with advanced pancreatic cancer and cholangiocarcinoma. Patients will be enrolled after informed consent and will undergo a dose escalation phase to determine the appropriate treatment dose. Following this, participants will receive the determined dose every four weeks for up to four cycles. The primary goal is to evaluate the treatment's safety and effectiveness in these patient populations.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with advanced pancreatic cancer or cholangiocarcinoma who have previously failed at least two lines of systemic chemotherapy.

Not a fit: Patients with early-stage cancer or those who have not undergone prior systemic chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced pancreatic cancer and cholangiocarcinoma.

How similar studies have performed: While this approach is exploratory, similar studies using PRRT have shown promise in treating other types of cancers.

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.

Where this trial is running

Hangzhou, Zhejiang

• First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Tingbo Liang, PhD

Conditions: Advanced Pancreatic Cancer and Cholangiocarcinoma