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Safety and efficacy of albumin-bound paclitaxel in combination with immunotherapy as second-line treatment for malignant biliary tract tumors

Safety and efficacy of albumin-bound paclitaxel in combination with immunotherapy as second-line treatment for malignant biliary tract tumors

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600116737
Enrollment
Unknown
Registered
2026-01-14
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract cancer

Interventions

Immunotherapy + albumin-bound paclitaxel:No

Sponsors

the Second Affiliated Hospital of Nanchang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Histologically or cytologically confirmed locally advanced or metastatic biliary tract malignancies; (2) Age between 18 and 75 years old, with a life expectancy of >=3 months; (3) Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; (4) Disease progression or intolerance after prior systemic chemotherapy; (5) No prior treatment with taxane medications, including but not limited to paclitaxel, paclitaxel liposome, albumin-bound paclitaxel, and docetaxel; (6) Measurable disease according to RECIST version 1.1 criteria.

Exclusion criteria

Exclusion criteria: (1) Severe comorbidities such as severe hepatic dysfunction or renal insufficiency. (2) History of allergy or severe adverse reactions to other taxane drugs. (3) Pregnant or nursing women. (4) Uncontrolled serious complications such as brain metastases.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
overall Survival;Treatment-related adverse events;

Countries

China

Contacts

Public ContactYe Mao

the Second Affiliated Hospital of Nanchang University

rayooocat111@163.com+86 136 8403 5878

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026