NCT06963060Enrolling by invitationPhase 2
Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)
Xinhua Hospital A Ffiliated to Shanghai Jiaotong University School of Medicine
Source: ClinicalTrials.gov · Last updated 8 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 7 Apr 2025
- Start date
- 1 Jun 2024
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Wei Gong
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06963060
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From 1 Jun 2024 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in other clinical trials within 30 days prior to enrollment.
- 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.
Other illness
- Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disorders, psychiatric conditions).
- Known hypersensitivity or intolerance to study drugs or their excipients.
Other
- Pregnancy, lactation, or refusal to use effective contraception.
- Inability to understand or unwillingness to sign informed consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.