OncoMatch/Clinical Trials/NCT07159204
Polymeric Micellar Paclitaxel-Based Combination Therapy for Advanced Biliary Tract Cancer
Official title: Polymeric Micellar Paclitaxel-Based Chemoimmunotherapy Plus Lenvatinib After First-Line Chemoimmunotherapy in Advanced Biliary Tract Cancer
Is NCT07159204 recruiting? Yes, currently enrolling (Oct 2026). This Phase 2 trial studies Paclitaxel polymer micelle immunocombination for biliary tract cancer (btc).
Treatment: Paclitaxel polymer micelle immunocombination — After the standard first-line treatment, the treatment regimen was adjusted to a paclitaxel polymer micellar-based immunotherapy combination regimen
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage IIIA, IIIB, IIIC, IVA, IVB
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: systemic therapy — first-line for advanced biliary tract cancer
Patients had disease progression after, or intolerance to, first-line systemic therapy for at least 1 month and required subsequent palliative systemic treatment.
Cannot have received: polymeric micellar paclitaxel or its analogues
Prior treatment with polymeric micellar paclitaxel or its analogues, or known hypersensitivity or intolerance to polymeric micellar paclitaxel, paclitaxel or its components, lenvatinib, or the planned immune checkpoint inhibitor.
Lab requirements
Blood counts
Hematologic and organ function adequate based on laboratory results within 14 days prior to therapy. Acute toxicities from prior treatment should have recovered to NCI-CTCAE v5.0 grade 1 or lower.
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance >50 mL/min. Renal failure requiring dialysis excluded.
Liver function
Active hepatitis B or hepatitis C patients required to receive antiviral therapy. HBV DNA <2,000 IU/mL (<10⁴ copies/mL), anti-HBV therapy ≥14 days before entry and continued during treatment. HCV RNA-positive patients should receive antiviral therapy per guidelines, with liver function abnormality no higher than CTCAE grade 1. Severe hepatic dysfunction excluded: jaundice, ascites, or bilirubin >3×ULN.
Hematologic and organ function were adequate based on laboratory results obtained within 14 days prior to initiation of investigational therapy. Severe hepatic or renal dysfunction, including jaundice, ascites, or bilirubin >3×ULN; renal failure requiring dialysis; or clinically significant proteinuria [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07159204 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior polymeric micellar paclitaxel or its analogues disqualifies patients from enrollment.
What disease stage is eligible?
Stage IIIA or IIIB or IIIC or IVA or IVB is required.
Is there an age limit?
Yes. Patients must be 74 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages