OncoMatch/Clinical Trials/NCT07159204
Paclitaxel mIcelle Later-line cOmbined immunoTherapy for Biliary Tract Cancer
Is NCT07159204 recruiting? Yes, currently enrolling (May 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
Cancer type
Cholangiocarcinoma
Disease stage
Required: Stage IIIA, IIIB, IIIC, IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — first-line
Patients were intolerant or failed for ≥1 month after first-line systemic therapy
Cannot have received: immune checkpoint inhibitor
previously received treatment with immune checkpoint inhibitors
Cannot have received: VEGFR inhibitor (lenvatinib)
previously received treatment with ... lenvatinib
Cannot have received: taxane (paclitaxel)
previously received treatment with ... paclitaxel
Cannot have received: systemic anti-tumor treatment
Exception: treatment allowed if completed ≥4 weeks before randomization
Any systemic anti-tumor treatment received within the three months prior to participating in the study ... Treatment is allowed 4 weeks before randomization.
Lab requirements
Blood counts
adequate, based on laboratory results within 14 days prior to initiation of investigational therapy
Kidney function
creatinine ≤1.5×ULN, or creatinine clearance >50mL/min; renal insufficiency: creatinine ratio >3.5g/24 hours, urine protein ≥++, or 24-hour urine protein quantification >1.0g, or renal failure requiring dialysis excluded
Liver function
liver function within CTCAE grade 1 elevation; bilirubin >3×ULN excluded; jaundice, ascites excluded
Hematology and organ function are adequate ... Adequate renal function: creatinine ≤1.5×ULN, or creatinine clearance >50mL/min ... Liver insufficiency: Characterized by jaundice, ascites and/or bilirubin >3×ULN [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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