Advanced CholangiocarcinomaPhase 3NCT05823311
Lenvatinib, Tislelizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
A Phase 3 study testing Lenvatinib, tislelizumab, gemcitabine and cisplatin and Gemcitabine and cisplatin in people with Advanced Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cholangiocarcinoma
- What is being tested?
- Lenvatinib, tislelizumab, gemcitabine and cisplatin and Gemcitabine and cisplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
weilin wang, doctor, +86 0571 87783820, wam@zju.edu.cn
About this study
Official title: A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
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.
- Conditions
- Advanced Cholangiocarcinoma
- Being tested
- Lenvatinib, tislelizumab, gemcitabine and cisplatin, Gemcitabine and cisplatin
- Keywords
- Lenvatinib, Tislelizumab, Gemcitabine and Cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenvatinib, tislelizumab, gemcitabine and cisplatinDrug
Intravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib.
Gemcitabine and cisplatinDrug
Intravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo.
| Study group | Role | What they receive |
|---|---|---|
| GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin) | Experimental | Intravenous injection: gemcitabine and cisplatin (CG)+ tislelizumab； Oral administration: lenvatinib. Receives: Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatin |
| CG (Gemcitabine and Cisplatin) | Placebo comparator | Intravenous injection: gemcitabine and cisplatin (CG)+placebo； Oral administration: placebo. Receives: Drug: Gemcitabine and cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective remission rate (ORR)
The proportion of patients with at least one complete response (CR) or partial response (PR) (%)
Measured: At the end of 4 treatment cycles(each cycle is 21 days)
Secondary outcomes (2)
Progression-free survival (PFS)
The time between the date of randomization and the date of radiographic progression
Measured: From date of randomization until the date of first documented progression, assessed up to 60 months
Overall survival time (OS)
The time between the date of randomization and death from any cause
Measured: From date of randomization until the date of death from any cause, assessed up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2023
- Study start1 Sep 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CholangiocarcinomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Third Affiliated Hospital of Xinjiang Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05823311
- Sponsor's protocol ID
- 2023-0175
- Status last verified
- Jan 2025
- First submitted
- 12 Mar 2023
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multicenter Study of Lenvatinib, Temalizumab Combined with Gemcitabine and Cisplatin (GPLET) in the Treatment of Advanced Cholangiocarcinoma
- ClinicalTrials.gov ID
- NCT05823311
- Acronym / sponsor ID
- 2023-0175
- Conditions
- Advanced Cholangiocarcinoma
- Keywords
- Lenvatinib, Tislelizumab, Gemcitabine and Cisplatin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Zhengzhou University, Third Affiliated Hospital of Xinjiang Medical University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin) | Experimental | Drug: Lenvatinib, tislelizumab, gemcitabine and cisplatinIntravenous injection: gemcitabine and cisplatin (CG)+ tislelizumab； Oral administration: lenvatinib. |
| CG (Gemcitabine and Cisplatin) | Placebo comparator | Drug: Gemcitabine and cisplatinIntravenous injection: gemcitabine and cisplatin (CG)+placebo； Oral administration: placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- Active or previously documented autoimmune disease or inflammatory disease.
- Uncontrolled complications.
- History of other primary malignancies.
- Active infection.
- Women who are pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lenvatinib, tislelizumab, gemcitabine and cisplatinIntravenous injection: gemcitabine and cisplatin (CG) + tislelizumab； Oral administration: lenvatinib. | Drug | GPLET (Lenvatinib, Tislelizumab Plus Gemcitabine and Cisplatin) |
| Gemcitabine and cisplatinIntravenous injection: gemcitabine and cisplatin (CG) + placebo； Oral administration: placebo. | Drug | CG (Gemcitabine and Cisplatin) |
Primary outcome
Objective remission rate (ORR)
Time frame: At the end of 4 treatment cycles(each cycle is 21 days)
The proportion of patients with at least one complete response (CR) or partial response (PR) (%)
2 secondary outcomes
Progression-free survival (PFS)
Time frame: From date of randomization until the date of first documented progression, assessed up to 60 months
Overall survival time (OS)
Time frame: From date of randomization until the date of death from any cause, assessed up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lenvatinib, tislelizumab, gemcitabine and cisplatin and Gemcitabine and cisplatin in people with Advanced Cholangiocarcinoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Weilin Wang, doctor (+86 0571 87783820, wam@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective remission rate (ORR) (time frame: At the end of 4 treatment cycles(each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.