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

Launched by WEI GONG · Apr 29, 2025

Keywords

ClinConnect Summary

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 + Le...

Gender

ALL

Eligibility criteria

• 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.