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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Advanced Cholangiocarcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin)

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

Group Type EXPERIMENTAL

Lenvatinib, tislelizumab, gemcitabine and cisplatin

Intervention Type DRUG

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

CG (Gemcitabine and Cisplatin)

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

Group Type PLACEBO_COMPARATOR

Gemcitabine and cisplatin

Intervention Type DRUG

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

Interventions

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Lenvatinib, tislelizumab, gemcitabine and cisplatin

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

Intervention Type DRUG

Gemcitabine and cisplatin

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No