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Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients with Initial Unresectable Biliary Tract Cancer: A Non-randomised, Open-Label, Phase II Study

Lenvatinib Plus PD-1 Inhibitors as First-Line Treatment in Patients with Initial Unresectable Biliary Tract Cancer: A Non-randomised, Open-Label, Phase II Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044476
Enrollment
Unknown
Registered
2021-03-19
Start date
2018-03-01
Completion date
Unknown
Last updated
2021-09-20

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

Conditions

Advanced Biliary Tract Carcinoma

Interventions

Case series:Lenvatinib combined with PD1 inhibitor

Sponsors

The Second Affiliated hospital of Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
37 Years to 84 Years

Inclusion criteria

Inclusion criteria: 1. Aged >=18 years; 2. BTC patients confirmed by pathological reports; 3. There is at least 1 measurable lesion defined according to RECIST v1.1 or a measurable lesion with a clear progression after local treatment (based on RECIST V1.1 standards); 4. Liver function is Child-Pugh Class A; 5. ECOG PS<=1; 5. No obvious blood system and immune system defects; 6. Sign the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Hepatocellular carcinoma or non-biliary tract tumor metastasis; 2. Tumor lesions cannot be assessed; 3. Have received any targeted, immunotherapy or radiotherapy; 4. Have a history of autoimmune diseases or immunodeficiency; 5. Have received other clinical trials within 4 weeks before the first dose; 6. Female patients who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
Objective response rate(ORR);Conversion surgery rate;Safety;

Secondary

MeasureTime frame
Disease control rate;Progression-free survival;Event-free survival;Overall survival;

Countries

China

Contacts

Public ContactSheng Yan

The Second Affiliated Hospital of Zhejiang University School of Medicine

shengyan@zju.edu.cn+86 13957161680

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026