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

NCT05509478 | Unknown Phase 2

• 1 other identifier: FirstJlinU
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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

Keywords

Biliary Tract Cancer; PD-1 inhibitors; lenvatinib

Outcome Measures

Primary Outcomes (1)

• ORR

  ORR was assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. ORR was defined as the percentage of participants with best overall response (BOR) of complete response (CR) or partial response (PR). Confirmation of CR or PR was performed at least 28 days following the initial achievement of the response

  12-months

Secondary Outcomes (5)

• Disease Control Rate (DCR)

  12-months

• Progression-free Survival (PFS)

  12-months

• Overall Survival (OS)

  24-months

• Overall Survival (OS) Rate at 9 months

  9-months

• Overall Survival (OS) Rate at 12 months

  12-months

Study Arms (1)

Lenvatinib+PD-1 inhibitors

EXPERIMENTAL

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

Drug: Lenvatinib; Drug: PD-1 inhibitors

Interventions

Lenvatinib DRUG

8 mg once daily (QD) oral dosing.

Also known as: E7080, Lenvima

Lenvatinib+PD-1 inhibitors

PD-1 inhibitors DRUG

Regular dose intravenously every 3 weeks

Lenvatinib+PD-1 inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients had good compliance, understood the study procedure, and signed written informed consent
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 2, Patients cannot tolerate chemotherapy or refuse to receive chemotherapy for any reason.
• Pathologically or cytologically confirmed biliary tract cancer
• Patients who are advanced and/or unresectable after imaging and multidisciplinary consultation
• Patients must have at least one measurable lesion as defined by RECIST 1.1
• Survival expectation of 12 weeks or longer after beginning of study treatment
• 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
• Patients requiring biliary stent implantation must complete the procedure at least 14 days before enrollment

You may not qualify if:

• Allergy to Lenvatinib or PD-1 inhibitors
• Patients who have had other malignancies within the past 2 years (except cured carcinoma in situ and basal cell carcinoma of the skin)
• 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
• Patients with ampullary carcinoma are excluded (patients with mixed HCC/ BTC may be considered)
• 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
• Major surgery prior to initiation of the study intervention and insufficient recovery from surgery and/or surgical complications
• 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)
• Patients after organ transplantation
• Known to have active tuberculosis (TB: tubercle bacilli)
• Complete or incomplete intestinal obstruction
• 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;
• Patients considered unsuitable for study judged by the researcher

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

Liu Bo

Changchun, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

lenvatinib; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

liu bo, master

CONTACT

15844057274; liuboliubo1109@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2022
• First Posted: August 22, 2022
• Study Start: August 20, 2022
• Primary Completion: February 1, 2023
• Study Completion: September 1, 2023
• Last Updated: September 10, 2022

Record last verified: 2022-09

Locations

CN (1)