Combination treatment for advanced cholangiocarcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the safety and efficacy of a combination therapy using Lenvatinib, Tislelizumab, Gemcitabine, and Cisplatin for patients with advanced cholangiocarcinoma. The approach aims to leverage the synergistic effects of targeted therapy and immunotherapy to combat this aggressive cancer. By targeting the tumor microenvironment and enhancing anti-tumor immune responses, the study seeks to improve treatment outcomes for patients who are typically diagnosed at an advanced stage. Participants will receive the treatment regimen and be monitored for safety and efficacy outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histologically proven, unresectable advanced or metastatic cholangiocarcinoma patients.
* Expected survival period \> 12 weeks.
* The World Health Organization (WHO) / ECOG physical status (PS) was 0 or 1.
* There was at least one target lesion that matched the RECIST 1.1 criteria at baseline.
* Not previously received immunotherapy, including but not limited to CTLA 4, PD-L1 or/and PD-1 inhibitors.
* Adequate organ and bone marrow function, defined as follows: Hemoglobin (Hb)≥9.0g/dL; Neutrophils (ANC) ≥ 1.5\* 10\^9/L; Platelet (Pt) ≥ 50\*10\^9/L; ALT≤2.5×ULN（Normal upper limit); AST≤2.5×ULN.
* Voluntary participation and signing of informed consent.

Exclusion Criteria:

* Active or previously documented autoimmune disease or inflammatory disease.
* Uncontrolled complications.
* History of other primary malignancies.
* Active infection.
* Women who are pregnant or breastfeeding.
* Patients with severe allergic history or specific constitution.
* Researchers consider it inappropriate to participate in the test.

Where it's running

• The Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Weilin Wang, doctor
• Email: wam@zju.edu.cn
• Phone: +86 0571 87783820

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.