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ENROLLING BY INVITATION

NCT06963060

PHASE2

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

Sponsor: Wei Gong

View on ClinicalTrials.gov

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.

Official title: Xinhua Hospital A Ffiliated to Shanghai Jiaotong University School of Medicine

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-01

Completion Date

2027-06-30

Last Updated

2025-05-08

Healthy Volunteers

Conditions

Gallbladder Cancer Cholangiocarcinoma

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.

Inclusion Criteria: 1. Aged 18-75 years, regardless of gender. 2. 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). 3. ECOG performance status score 0-1. 4. Expected survival ≥3 months. 5. At least one measurable target lesion per RECIST v1.1 criteria. 6. 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. 7. No prior systemic therapy for advanced BTC (chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hormonal therapy). Patients with post-R2 resection are eligible. 8. Negative serum/urine pregnancy test (for women of childbearing potential) and agreement to use contraception during the study and for 6 months post-treatment. 9. Willing and able to provide written informed consent. Exclusion Criteria: 1. Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disorders, psychiatric conditions). 2. Known hypersensitivity or intolerance to study drugs or their excipients. 3. Pregnancy, lactation, or refusal to use effective contraception. 4. Participation in other clinical trials within 30 days prior to enrollment. 5. Inability to understand or unwillingness to sign informed consent. 6. Any condition that, in the investigator's judgment, may compromise patient safety or compliance (e.g., severe concurrent illness, abnormal lab results, psychosocial factors). 7. Prior use of PD-1/L1 inhibitors, gemcitabine, nab-paclitaxel, or lenvatinib in adjuvant/neoadjuvant settings.

Locations (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China