Lenvatinib Combined With PD-1 Inhibitors as First-line Treatment for Unresectable/Advanced Biliary Tract Carcinoma

NCT ID: NCT05509478

Last Updated: 2022-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-20
• Study Completion Date: 2023-09-01

Brief Summary

This is a multi-center, single-arm,phase Ⅱ study to evaluate the efficacy and safety of Lenvatinib in combination with PD-1 inhibitors as first-line treatment in patients with unresectable advanced Biliary Tract Carcinoma (BTC)

Conditions

Biliary Tract Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lenvatinib+PD-1 inhibitors

Participants received lenvatinib capsules 8 mg , orally, once daily (QD) PD-1 inhibitors in this study include, but not limited to, Pembrolizumab, nivolumab, sintilimab, toripalimab, etc. The usage and dosage refer to label information or other clinical study

Group Type: EXPERIMENTAL

Lenvatinib

Intervention Type: DRUG

8 mg once daily (QD) oral dosing.

PD-1 inhibitors

Intervention Type: DRUG

Regular dose intravenously every 3 weeks

Interventions

Lenvatinib

8 mg once daily (QD) oral dosing.

Intervention Type: DRUG

PD-1 inhibitors

Regular dose intravenously every 3 weeks

Intervention Type: DRUG

Other Intervention Names

E7080, Lenvima

Eligibility Criteria

Inclusion Criteria

1. Patients had good compliance, understood the study procedure, and signed written informed consent

2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 2, Patients cannot tolerate chemotherapy or refuse to receive chemotherapy for any reason.

3. Pathologically or cytologically confirmed biliary tract cancer

4. Patients who are advanced and/or unresectable after imaging and multidisciplinary consultation

5. Patients must have at least one measurable lesion as defined by RECIST 1.1

6. Survival expectation of 12 weeks or longer after beginning of study treatment

7. The major organs meeting the following criteria:

Adequate bone marrow function,defined as: Hemoglobin (HGB) ≥80g/L;Neutrophil absolute count (ANC) ≥1.0×10^9/L;Platelet (PLT) ≥60×10^9/L

Adequate liver function, defined as: aspartate aminotransferase (AST), and alanine aminotransferase (ALT) ≤ 2.5× upper limit of normal (ULN) ( ≤ 5.0 × ULN for participants with the liver transplantion);Serum total bilirubin（STB） <1.5×ULN

Adequate renal function ，defined as：Serum creatinine was within 1.5 times the normal range

8. Patients requiring biliary stent implantation must complete the procedure at least 14 days before enrollment

Exclusion Criteria

1. Allergy to Lenvatinib or PD-1 inhibitors

2. Patients who have had other malignancies within the past 2 years (except cured carcinoma in situ and basal cell carcinoma of the skin)

3. Patients who have previously received systemic therapy, except for permitted neoadjuvant/adjuvant therapy, neoadjuvant/adjuvant therapy should be completed at least 4 months before diagnosis of advanced and/or unresectable disease

4. Patients with ampullary carcinoma are excluded (patients with mixed HCC/ BTC may be considered)

5. Active autoimmune disease requiring systemic treatment (i.e. corticosteroids or immunosuppressive drugs) within the past 2 years.Alternative therapies (e.g., thyroxine, insulin, or physical corticosteroid replacement for adrenal or pituitary insufficiency) are not considered systemic and permitted

6. Major surgery prior to initiation of the study intervention and insufficient recovery from surgery and/or surgical complications

7. Radiation therapy was received within 2 weeks prior to initiation of study therapy. Or the subject must have recovered from all radiation-related toxicity, not required corticosteroids, and have not experienced radiation pneumonia; Palliative radiotherapy for non-central nervous system (CNS) disease (≤2 weeks) allows a washout period of 1 week (if deemed safe by the investigator)

8. Patients after organ transplantation

9. Known to have active tuberculosis (TB: tubercle bacilli)

10. Complete or incomplete intestinal obstruction

11. Have serious comorbidities that may affect study administration or evaluation of study results, such as HIV positive, active chronic HBV/HCV, clinically severe (i.e., active) heart disease, uncontrolled epilepsy, central nervous system disease, or psychiatric disorders;

12. Patients considered unsuitable for study judged by the researcher

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Liu Bo

Changchun, Jilin, China

Site Status: RECRUITING

Countries

China

Central Contacts

liu bo, master

Role: CONTACT

liuboliubo1109@163.com

15844057274

Facility Contacts

liu bo, master

Role: primary

liuboliubo1109@163.com

15844057274

Other Identifiers

FirstJlinU

Identifier Type: -

Identifier Source: org_study_id