Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:21 AM
Study NCT ID:
NCT06963060
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-08
First Post:
2025-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)
Sponsor:
Wei Gong
Organization:
Study Overview
Official Title:
Xinhua Hospital A Ffiliated to Shanghai Jiaotong University School of Medicine
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GALENT-BT
Brief 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.
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.
Detailed Description:
1. Study Background Biliary tract malignancies (BTCs), including gallbladder cancer (GBC), intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (ECC), are aggressive cancers with a 5-year survival rate \<5%. Current first-line systemic therapies (e.g., gemcitabine/cisplatin) yield limited efficacy (ORR \<30%, median OS \~11.7 months). Preclinical and clinical evidence suggests synergistic effects of combining chemotherapy, anti-angiogenic agents, and immune checkpoint inhibitors. The GALENT-BT trial evaluates a novel quadruplet regimen-Gemcitabine + nab-Paclitaxel + Lenvatinib + Tislelizumab-to improve outcomes in advanced unresectable BTCs.
2. Study Objectives
Primary Objective: Assess the safety and tolerability of the quadruplet regimen over 8 treatment cycles.
Secondary Objectives:
Evaluate objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and surgical conversion rate.
Monitor adverse events (AEs), serious adverse events (SAEs), and quality of life (QoL).
Exploratory Objectives: Investigate biomarkers (e.g., PD-L1 expression, genetic mutations) and radiomic/pathologic features associated with treatment response.
3. Study Design
Design: Prospective, single-arm, open-label, single-center, phase II trial.
Sample Size: Two-stage enrollment:
Stage 1 (Lead-in): 9 participants for initial safety evaluation. If ≤3/9 experience grade ≥3 AEs, proceed to Stage 2.
Stage 2 (Expansion): 20 additional participants (total 29 evaluable patients).
Duration: 36 months (June 2024-June 2027).
4. Study Population
Inclusion Criteria:
Adults aged 18-75 years with histologically confirmed, untreated, advanced unresectable BTC (GBC/ICC/ECC) or recurrent BTC (≥3 months post-adjuvant therapy).
ECOG PS 0-1, measurable disease per RECIST 1.1, adequate organ function.
Exclusion Criteria: Prior systemic therapy for advanced BTC, severe comorbidities, pregnancy, or intolerance to study drugs.
5. Intervention
Regimen:
Gemcitabine: 1000 mg/m² IV on Days 1 and 8 of each 21-day cycle.
nab-Paclitaxel: 125 mg/m² IV on Days 1 and 8.
Lenvatinib: 4-8 mg orally daily (weight-based dosing) on Days 1-21.
Tislelizumab: 200 mg IV on Day 1.
Treatment Duration: 6-8 cycles (adjustable for tolerability), followed by 3-year survival follow-up.
6. Assessments
Efficacy:
Tumor response evaluated by CT/MRI every 6 weeks using RECIST 1.1.
ORR, DCR, PFS, OS, and surgical conversion rate calculated.
Safety:
AEs/SAEs graded per CTCAE v5.0.
Laboratory monitoring (hematology, liver/renal function, thyroid panels).
QoL: Assessed via EORTC QLQ-HCC18 questionnaire at baseline, treatment cycles, and follow-up.
2. Study Objectives
Primary Objective: Assess the safety and tolerability of the quadruplet regimen over 8 treatment cycles.
Secondary Objectives:
Evaluate objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and surgical conversion rate.
Monitor adverse events (AEs), serious adverse events (SAEs), and quality of life (QoL).
Exploratory Objectives: Investigate biomarkers (e.g., PD-L1 expression, genetic mutations) and radiomic/pathologic features associated with treatment response.
3. Study Design
Design: Prospective, single-arm, open-label, single-center, phase II trial.
Sample Size: Two-stage enrollment:
Stage 1 (Lead-in): 9 participants for initial safety evaluation. If ≤3/9 experience grade ≥3 AEs, proceed to Stage 2.
Stage 2 (Expansion): 20 additional participants (total 29 evaluable patients).
Duration: 36 months (June 2024-June 2027).
4. Study Population
Inclusion Criteria:
Adults aged 18-75 years with histologically confirmed, untreated, advanced unresectable BTC (GBC/ICC/ECC) or recurrent BTC (≥3 months post-adjuvant therapy).
ECOG PS 0-1, measurable disease per RECIST 1.1, adequate organ function.
Exclusion Criteria: Prior systemic therapy for advanced BTC, severe comorbidities, pregnancy, or intolerance to study drugs.
5. Intervention
Regimen:
Gemcitabine: 1000 mg/m² IV on Days 1 and 8 of each 21-day cycle.
nab-Paclitaxel: 125 mg/m² IV on Days 1 and 8.
Lenvatinib: 4-8 mg orally daily (weight-based dosing) on Days 1-21.
Tislelizumab: 200 mg IV on Day 1.
Treatment Duration: 6-8 cycles (adjustable for tolerability), followed by 3-year survival follow-up.
6. Assessments
Efficacy:
Tumor response evaluated by CT/MRI every 6 weeks using RECIST 1.1.
ORR, DCR, PFS, OS, and surgical conversion rate calculated.
Safety:
AEs/SAEs graded per CTCAE v5.0.
Laboratory monitoring (hematology, liver/renal function, thyroid panels).
QoL: Assessed via EORTC QLQ-HCC18 questionnaire at baseline, treatment cycles, and follow-up.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: