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Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)

NCT06963060 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-05-08

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of combining Gemcitabine, nab-Paclitaxel, Lenvatinib, and Tislelizumab in adults aged 18-75 years with advanced unresectable biliary tract malignancies (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma). The main questions it aims to answer are:

What is the objective response rate (ORR) of this quadruplet regimen as first-line therapy?

What are the secondary outcomes, including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile?

This is a single-arm, open-label, phase II study with no comparison group.

Participants will:

Receive Gemcitabine (1000 mg/m² IV on Days 1 and 8) and nab-Paclitaxel (125 mg/m² IV on Days 1 and 8) every 3 weeks.

Take Lenvatinib (4-8 mg orally daily on Days 1-21).

Receive Tislelizumab (200 mg IV on Day 1) every 3 weeks.

Undergo 6-8 treatment cycles (adjusted for tolerability) with regular imaging, laboratory tests, and safety assessments.

Be followed for 3 years to monitor survival and long-term outcomes.

The study plans to enroll 29 participants and will be conducted at a single center over 36 months.

Conditions

Interventions

DRUG

Gemcitabine nab-PaclitaxelLenvatinibTislelizumab

Receive Gemcitabine (1000 mg/m² IV on Days 1 and 8) and nab-Paclitaxel (125 mg/m² IV on Days 1 and 8) every 3 weeks. Take Lenvatinib (4-8 mg orally daily on Days 1-21). Receive Tislelizumab (200 mg IV on Day 1) every 3 weeks.

Sponsors & Collaborators

  • Wei Gong

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06963060 on ClinicalTrials.gov