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

NCT06963060 | Enrolling By Invitation Phase 2

• 1 other identifier: XHEC-C-2024-121-2
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Gallbladder Cancer; Cholangiocarcinoma

Keywords

advanced unresectable biliary tract malignancies

Outcome Measures

Primary Outcomes (1)

• ORR

  The objective response rate (ORR) of this quadruplet regimen as first-line therapy

  At the end of Cycle 8 (each cycle is 21 days)

Secondary Outcomes (4)

• Surgical Conversion Rate

  At the end of Cycle 8 (each cycle is 21 days)

• Disease control rate (DCR)

  At the end of Cycle 8 (each cycle is 21 days)

• Overall Survival (OS)

  The end of the 3-year follow-up period

• Progression-Free Survival (PFS)

  At the end of disease progression or death during the 3-year follow-up period

Study Arms (1)

Treatment

EXPERIMENTAL

Gemcitabine ,nab-Paclitaxel,Lenvatinib and Tislelizumab

Drug: Gemcitabine nab-PaclitaxelLenvatinibTislelizumab

Interventions

Gemcitabine nab-PaclitaxelLenvatinibTislelizumab DRUG

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.

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-75 years, regardless of gender.
• Histologically or cytologically confirmed, untreated primary advanced unresectable biliary tract malignancies (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic chololiocarcinoma (ECC), and gallbladder cancer (GBC); or untreated recurrent BTC (prior adjuvant/neoadjuvant chemotherapy allowed if completed ≥3 months before recurrence, excluding regimens containing PD-1/L1 inhibitors, gemcitabine, nab-paclitaxel, or lenvatinib).
• ECOG performance status score 0-1.
• Expected survival ≥3 months.
• At least one measurable target lesion per RECIST v1.1 criteria.
• Adequate organ function:
• Hematologic: Hemoglobin ≥90 g/L; WBC ≥lower limit of normal (LLN); ANC ≥1.5×10⁹/L; platelets ≥100×10⁹/L.
• Renal: Serum creatinine ≤1.5×ULN; endogenous creatinine clearance rate ≥55 mL/min.
• Hepatic: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤3×ULN for intrahepatic BTC or liver metastases; ALT/AST ≤5×ULN for liver metastases).
• Coagulation: INR ≤1.5×ULN; APTT within normal range.
• No prior systemic therapy for advanced BTC (chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hormonal therapy). Patients with post-R2 resection are eligible.
• Negative serum/urine pregnancy test (for women of childbearing potential) and agreement to use contraception during the study and for 6 months post-treatment.
• Willing and able to provide written informed consent.

You may not qualify if:

• Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disorders, psychiatric conditions).
• Known hypersensitivity or intolerance to study drugs or their excipients.
• Pregnancy, lactation, or refusal to use effective contraception.
• Participation in other clinical trials within 30 days prior to enrollment.
• Inability to understand or unwillingness to sign informed consent.
• Any condition that, in the investigator's judgment, may compromise patient safety or compliance (e.g., severe concurrent illness, abnormal lab results, psychosocial factors).
• Prior use of PD-1/L1 inhibitors, gemcitabine, nab-paclitaxel, or lenvatinib in adjuvant/neoadjuvant settings.

Sponsors & Collaborators

• Wei Gong: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

MeSH Terms

Conditions

Gallbladder Neoplasms; Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Xinhua Hospital A ffiliated to Shanghai Jiaotong University School of Medicine

Study Record Dates

• First Submitted: April 7, 2025
• First Posted: May 8, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)