Potentially Resectable Locally Advanced Malignant Tumors of Biliary SystemPhase 2NCT05036798
Tislelizumab+Lenvatinib+Gemox Regiment for Potentially Resectable Locally Advanced Malignant Tumors of Biliary System.
A Phase 2 study testing Tislelizumab in people with Potentially Resectable Locally Advanced Malignant Tumors of Biliary System, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.
Trial summary
This is a single-arm, open, Phase II clinical study of Tislelizumab combined with lenvatinib and Gemox regimen for transformational treatment of potentially resectable locally advanced malignant tumors of biliary system. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Potentially Resectable Locally Advanced Malignant Tumors of Biliary System
- What is being tested?
- Tislelizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 17 Sep 2021to 30 Dec 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 20 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histological diagnosis of potentially resectable local advanced biliary malignancies (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma, ampullary carcinoma);
- Potential resectable criteria: The first-stage R0 resection cannot be guaranteed for patients with cholangiocarcinoma admitted to our hospital, and there are the following imaging characteristics (satisfy one or more) :
- The hilar and retroperitoneal lymph nodes were considered for metastasis but could be resected completely.
- Intrahepatic cholangiocarcinoma has multiple foci, but foci are less than three and limited to half of the liver.
- Local progression of gallbladder carcinoma with colon or duodenal involvement.
- Hilar cholangiocarcinoma or lower segment of cholangiocarcinoma involving portal vein or hepatic artery requires combined vascular resection or reconstruction; 2. Patient age 20-79 years; 3. At least one measurable lesion as defined in RECIST version 1.1; 4. ECOG score was 0-1; 5. No prior medical treatment; 6. Adequate organ and bone marrow function and laboratory tests meet the following requirements:
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- HGB≥90g/L；
- NEUT≥1.5×109/L；
- PLT ≥100×109/L；
- TBIL≤1.5 times normal upper limit (ULN);
- ALT and AST ≤2.5 x ULN;ALT and AST≤5×ULN for liver metastasis;
- Endogenous creatinine clearance ≥50ml/min (Cockcroft-Gault formula);
- Urinary protein < (++), or 24 hours urinary protein <1.0 g; 7. Coagulation was normal without active bleeding
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- International standardized ratio INR≤1.5;
- Partial thrombin time APTT≤1.5 ULN; 8. Women of childbearing age must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and voluntarily use an appropriate method of contraception during the observation period and within 8 weeks after the last administration of the study drug;For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 8 weeks after the last administration of the study drug; 9. Estimated survival ≥3 months; 10. The patients voluntarily participated in the study and signed the informed consent (ICF); 11. It is expected that patients with good compliance will be able to follow up the efficacy and adverse reactions according to protocol requirements.
- 12. Tumor tissue samples for PD-L1 expression analysis and microsatellite instability analysis.
Who cannot join
- The patient must be excluded from the study if any of the following conditions occur at the time of inclusion:
- 1. Allergic to known anti-PD-1 and anti-PD-L1 antibodies; 2. Patients with hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), grade I or above coronary heart disease, grade I arrhythmia (including prolonged QTc interval > 450 ms in males and > 470 ms in females) and grade I cardiac insufficiency; 3. Risk of biliary obstruction; 5. Allergic to the drugs of the program (gemcitabine, oxaliplatin); 6. Patients with a clear tendency of gastrointestinal bleeding, including the following conditions: local active ulcer lesions, and fecal occult blood (++) cannot be included in the group; Patients with a history of melena and hematemesis within 1 month; 7. Patients with immune system diseases need to take more than 10mg of dexamethasone daily; 8. Patients with concomitant diseases that, according to the judgment of the investigator, seriously endanger the patient's safety or affect the patient's ability to complete the study; 9. The researcher considered it unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
About this study
Official title: A Single-arm, Open, Phase II Clinical Study of Tislelizumab Combined With Lenvatinib and Gemox Regimen for Transformational Treatment of Potentially Resectable Locally Advanced Malignant Tumors of Biliary System.
This is a single-arm, open, Phase II clinical study of Tislelizumab combined with lenvatinib and Gemox regimen for transformational treatment of potentially resectable locally advanced malignant tumors of biliary system.
- Being tested
- Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Also called Lenvatinib, Gemox
Chemotherapy regimen:
Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1, q3W2 Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD
| Study group | Role | What they receive |
|---|---|---|
| Tislelizumab combined with Lenvatinib and GEMOX | Experimental | Chemotherapy regimen(GEMOX):
Gemcitabine 1g/m2,Oxaliplatin 100mg/m, D1, Q3W Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD
Receive at least 3 cycles of combined treatment, and perform imaging evaluation after 3 cycles of treatment. If surgical treatment is not possible, imaging evaluation will be performed every two cycles thereafter until surgical treatment is feasible. If more than 7 cycles are still not possible for surgical resection, enter Tislelizumab + Lenvatinib maintenance treatment until the disease progresses or the toxicity cannot be tolerated.
If patients undergoing R0 resection, start to receive Tislelizumab + Lenvatinib+Gemox regimen in 4-8 weeks after surgery for 7 cycles, and then entered Tislelizumab+Lenvatinib for 1 year or disease progression or toxicity cannot be tolerated Receives: Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 resection rate
Measured: 5 months
Secondary outcomes (5)
Progression-free survival (PFS)
Measured: 18 months
Disease control rate (DCR)
Measured: 5 months
Objective response rate (ORR)
Measured: 5 months
Overall survival (OS)
Measured: 24 months
Improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start17 Sep 2021
- Primary completion2 Jul 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Resectable Locally Advanced Malignant Tumors of Biliary SystemStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036798
- Sponsor's protocol ID
- GDS20210220320615
- Status last verified
- Aug 2022
- First submitted
- 31 Aug 2021
- Last updated
- 7 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open, Phase II Clinical Study of Tislelizumab Combined With Lenvatinib and Gemox Regimen for Transformational Treatment of Potentially Resectable Locally Advanced Malignant Tumors of Biliary System.
- ClinicalTrials.gov ID
- NCT05036798
- Acronym / sponsor ID
- GDS20210220320615
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 2 Jul 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 8 Sep 2021 (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.
This is a single-arm, open, Phase II clinical study of Tislelizumab combined with lenvatinib and Gemox regimen for transformational treatment of potentially resectable locally advanced malignant tumors of biliary system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tislelizumab combined with Lenvatinib and GEMOX | Experimental | Drug: TislelizumabChemotherapy regimen(GEMOX): Gemcitabine 1g/m2,Oxaliplatin 100mg/m, D1, Q3W Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD Receive at least 3 cycles of combined treatment, and perform imaging evaluation after 3 cycles of treatment. If surgical treatment is not possible, imaging evaluation will be performed every two cycles thereafter until surgical treatment is feasible. If more than 7 cycles are still not possible for surgical resection, enter Tislelizumab + Lenvatinib maintenance treatment until the disease progresses or the toxicity cannot be tolerated. If patients undergoing R0 resection, start to receive Tislelizumab + Lenvatinib+Gemox regimen in 4-8 weeks after surgery for 7 cycles, and then entered Tislelizumab+Lenvatinib for 1 year or disease progression or toxicity cannot be tolerated |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 1. Histological diagnosis of potentially resectable local advanced biliary malignancies (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder carcinoma, ampullary carcinoma);
- Potential resectable criteria: The first-stage R0 resection cannot be guaranteed for patients with cholangiocarcinoma admitted to our hospital, and there are the following imaging characteristics (satisfy one or more) :
- The hilar and retroperitoneal lymph nodes were considered for metastasis but could be resected completely.
- Intrahepatic cholangiocarcinoma has multiple foci, but foci are less than three and limited to half of the liver.
- Local progression of gallbladder carcinoma with colon or duodenal involvement.
Key exclusion criteria (2 listed)
- 1. Allergic to known anti-PD-1 and anti-PD-L1 antibodies; 2. Patients with hypertension (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), grade I or above coronary heart disease, grade I arrhythmia (including prolonged QTc interval > 450 ms in males and > 470 ms in females) and grade I cardiac insufficiency; 3. Risk of biliary obstruction; 5. Allergic to the drugs of the program (gemcitabine, oxaliplatin); 6. Patients with a clear tendency of gastrointestinal bleeding, including the following conditions: local active ulcer lesions, and fecal occult blood (++) cannot be included in the group; Patients with a history of melena and hematemesis within 1 month; 7. Patients with immune system diseases need to take more than 10mg of dexamethasone daily; 8. Patients with concomitant diseases that, according to the judgment of the investigator, seriously endanger the patient's safety or affect the patient's ability to complete the study; 9. The researcher considered it unsuitable for inclusion.
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 |
|---|---|---|
| TislelizumabAlso: Lenvatinib, GemoxChemotherapy regimen: Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1, q3W2 Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD | Drug | Tislelizumab combined with Lenvatinib and GEMOX |
Primary outcome
R0 resection rate
Time frame: 5 months
5 secondary outcomes
Progression-free survival (PFS)
Time frame: 18 months
Disease control rate (DCR)
Time frame: 5 months
Objective response rate (ORR)
Time frame: 5 months
Overall survival (OS)
Time frame: 24 months
Improvement in quality of life as measured by the EORTC Quality of Life Questionnaire QLQ-C30 (V3.0)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tislelizumab in people with Potentially Resectable Locally Advanced Malignant Tumors of Biliary System, run by Tianjin Medical University Cancer Institute and Hospital 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 17 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Sep 2022. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 resection rate (time frame: 5 months). 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 7 Sep 2022.