Skip to content

A single arm, multi-center, open lable, exploratory study of Tirelizumab combined with Nab-Paclitaxel and Gemcitabine in the treatment of patients with advanced biliary tract cancer

A single arm, multi-center, open lable, exploratory study of Tirelizumab combined with Nab-Paclitaxel and Gemcitabine in the treatment of patients with advanced biliary tract cancer

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063254
Enrollment
Unknown
Registered
2022-09-02
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-04-17

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

Conditions

biliary tract cancer

Interventions

case series:Tirelizumab + Nab-Paclitaxel + Gemcitabine

Sponsors

Shanghai Xuhui Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1. Pathological diagnosised as biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder carcinoma; 2. Potentially resectable, no distant metastasis, local progression; 3. At least one measurable lesion (RECIST 1.1); 4. ECOG performance status = 3 months; 7. Evaluated by the investigator as suitable for participating in the trial; 8. Potentially fertile male and female patients must consent to use an effective method of contraception throughout the study; 9. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. History of receiving systemic anti-tumor therapy; 2. History of allergic reactions to similar drugs; 3. Pregnant or lactating patients; 4. Pericardial effusion, uncontrolled pleural effusion, or clinically severe ascites(including ascites detected in physical examination or ascites required aspiration at the time of screening); 5. History of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases, including diabetes mellitus, hypertension, pulmonary fibrosis, and acute lung disease, et al.; 6. Severe cardiovascular disease, such as symptomatic coronary heart disease, grade II or higher congestive heart failure, uncontrolled arrhythmias, and myocardial infarction, occurred within 12 months before enrollment; 7. Other uncured malignancies; 8. Uncontrollable mental illness; 9. Any other factors that investigators considered inappropriate to participate in the study.

Design outcomes

Primary

MeasureTime frame
R0 Radical resection rate;

Secondary

MeasureTime frame
Event-free survival;Overall survival;

Countries

China

Contacts

Public ContactLiu Houbao

Shanghai Xuhui Central Hospital

liu.houbao@zs-hospital.sh.cn+86 18616881207

Outcome results

None listed

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