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Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma

ConditionAdvanced Cholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

Cholangiocarcinoma (CCA) is a heterogeneous group of cancers arising from the epithelial cells of bile ducts. Because of highly aggressive malignancy, most of the patients are diagnosed at an advanced stage and lose the chance to undergo surgery.

As more effective and novel chemotherapy, targeted therapies, and immunotherapy become available, multiple treatments can be chosen for the patients with advanced CCA. Cytotoxic cell death during tumor chemotherapy triggers antigen release and induces strong anti-tumor effects of T cells. Tyrosine kinase inhibitors (TKI) can reduce the expression of PD-L1 and inhibit Treg cell infiltration, and together with immune checkpoint inhibitors, they can relieve tumor immunosuppressive microenvironment.

Therefore, the study aims to investigate the safety and efficacy of Lenvatinib, Tislelizumab combined with Gemcitabine plus Cisplatin (GPLET) in the treatment of advanced cholangiocarcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Active or previously documented autoimmune disease or inflammatory disease.

Uncontrolled complications.

History of other primary malignancies.

Active infection.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Lenvatinib, tislelizumab, gemcitabine and cisplatin

    Drug

    Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib.

  • Gemcitabine and cisplatin

    Drug

    Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)Experimental treatment 1 intervention
Group B: CG (Gemcitabine and Cisplatin)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective remission rate (ORR)

The proportion of patients with at least one complete response (CR) or partial response (PR) (%)

Time frame
At the end of 4 treatment cycles(each cycle is 21 days)

Secondary outcomes

1

Progression-free survival (PFS)

The time between the date of randomization and the date of radiographic progression

Time frame
From date of randomization until the date of first documented progression, assessed up to 60 months
2

Overall survival time (OS)

The time between the date of randomization and death from any cause

Time frame
From date of randomization until the date of death from any cause, assessed up to 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

The First Affiliated Hospital of Zhengzhou University

Collaborator

The Affiliated Tumor Hospital of Xinjiang Medical University

Collaborator

Source ClinicalTrials.gov
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