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Gemcitabine, Cisplatin, plus nab-Paclitaxe as first-line treatment for advanced biliary tract cancer: a single-arm phase II study

Gemcitabine, Cisplatin, plus nab-Paclitaxe as first-line treatment for advanced biliary tract cancer: a single-arm phase II study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036850
Enrollment
Unknown
Registered
2020-08-25
Start date
2019-05-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Biliary tract cancer

Interventions

Gemcitabine, cisplatin plus nab-paclitaxel group:Gemcitabine, cisplatin plus nab-paclitaxel group

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma and gallbladder cancer diagnosed by imaging or pathology; (2) Locally advanced or distant-metastasizing biliary tract cancer; (3) PS score 0-1; (4) Aged 18 to 75 years; (5) Had not received anti-tumor treatment before; (6) Normally function of main organs; (7) Voluntary participation.

Exclusion criteria

Exclusion criteria: (1) Concomitant with other tumors; (2) The presence of autoimmune diseases, or the presence of comorbidities requiring long-term use of hormones; (3) The presence of peripheral neuropathy assessed as grade 2 or greater by the National Cancer Institute's Common terminology for adverse events version 4.0; (4) Central nervous system diseases excluding brain metastases; (5) Difficulty in long-term follow-up.

Design outcomes

Primary

MeasureTime frame
Median progression-free survival;Median overall survival;

Secondary

MeasureTime frame
Objective response rate;Disease control rate;Progression-free survival and overall survival rate of 6 and 12 months;Duration of response;Adverse event rate;

Countries

China

Contacts

Public ContactZhu Qing

West China Hospital, Sichuan University

newzhuqing1972@yahoo.com+86 18009252290

Outcome results

None listed

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