Biliary Tract TumorPhase 2NCT05291052
Tisleizumab Combined With Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors
A Phase 2 study testing Tislelizumab, Lenvatinib and Oxaliplatin in people with Biliary Tract Tumor, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study is a single-center, single-arm, open-label clinical study. All patients with advanced and unresectable biliary tract tumors will be treated with the combination of tisleizumab, lenvatinib and XELOX regimen (oxaliplatin plus capecitabine) until disease progression , unacceptable toxicity, death or the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Tumor
- What is being tested?
- Tislelizumab, Lenvatinib and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 14 Feb 2022to 30 Mar 2024
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible to participate in this study, a patient must meet all of the following criteria:
- Able to provide written informed consent and able to understand and agree to comply with study requirements and assessment schedules
- Histologically or cytologically confirmed unresectable or postoperative recurrent locally advanced or metastatic biliary tract tumors, including cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer;
- Aged 18-75 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) fitness status score (PS score) 0-1;
- Expected survival ≥ 3 months;
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- At least one measurable lesion according to RECIST V1.1;
- No previous systemic therapy, including chemotherapy, targeted therapy, immunotherapy;
- Adequate organ function as indicated by the following laboratory values ≤ 7 days prior to the first dose of study drug:
- Patients must not have required a transfusion of blood product or growth factor support within the 14 days before sample collection during the Screening Period and met all of the following criteria:
- Absolute neutrophil count（ANC）≥ 1.5 × 10^9/L
- Platelets ≥ 75 × 10^9/L
- Hemoglobin ≥ 90 g/L
- Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance > 50 μmol/L
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5 × ULN; if there is a lesion in liver, ALT or AST ≤ 5 × ULN;
- Serum total bilirubin ≤ 1.5 × ULN;
- International normalized ratio (INR) ≤ 1.5 or prothrombin time (PT) ≤ 1.5 × ULN
- Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN
- Cardiac Doppler ultrasound evaluation score (LVEF) ≥ 50%.
- Patients with positive hepatitis B surface antigen (HBsAg) or previous history of HBV infection must receive antiviral agents before the first dose of study drug and continue treatment during the study.
- Females of childbearing potential must agree to practice highly effective contraception during the study and for ≥ 120 days after the last dose of study drug and have a negative serum pregnancy test ≤ 7 days of the first study drug administration
- Nonsterilized male patients must agree to practice highly effective contraception for the duration of the study and for ≥ 120 days after study drug administration
- Good compliance and family agrees to cooperate with survival follow-up.
Who cannot join
- To be eligible to participate in this study, a patient cannot meet any of the following exclusion criteria:
- Any active malignancy ≤ 2 years prior to the first dose of study drug, except the specific cancers evaluated in this study and any curatively treated locally recurrent cancer (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast).
- Participation in other clinical trials within four weeks prior to the first dose of study drug;
- Patients with any evidence or history of bleeding diatheses regardless of severity; patients with any bleeding or bleeding event ≥ CTCAE grade 3 within 4 weeks before the first dose; patients with gastrointestinal diseases such as unhealed wound, fracture, active gastric and duodenal ulcer, ulcerative colitis or active bleeding of unresected tumor, or other conditions that may cause gastrointestinal bleeding and perforation judged by the investigator;
- Patients with uncontrolled brain metastasis, spinal cord compression, carcinomatous meningitis or brain or leptomeningeal disease found by CT or MRI within 4 weeks before the first dose of study drug;
- Patients with any severe and/or uncontrolled disease, including: a) patients with unsatisfactory blood pressure control (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 90 mmHg); b) unstable angina pectoris, myocardial infarction, ≥ grade 2 congestive heart failure, or arrhythmia requiring treatment (including QTc ≥ 480 ms) within 6 months before the first dose of study drug; c) severe chronic or active infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal or antiviral therapy within 14 days before the first dose of study drug, Note: patients with viral hepatitis are allowed to receive antiviral therapy; d) positive HIV test; e) poor control of diabetes (fasting blood glucose ≥ CTCAE grade 2); f) urine routine indicating urine protein ≥ 1 +, and confirmed 24-hour urine protein quantification > 1.0 g;
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- Patients with any active autoimmune disease or a history of autoimmune disease (such as, but not limited: autoimmune hepatitis, interstitial pneumonia, enteritis, vasculitis, nephritis; patients with asthma requiring medical intervention with bronchodilators can not be included); patients with the following are allowed: vitiligo, psoriasis, alopecia without systemic treatment, well-controlled type I diabetes, hypothyroidism after replacement therapy;
- If HCV RNA is detectable, the presence of HCV infection is confirmed and such patients are not eligible;
- Uncontrolled pleural effusion, pericardial effusion or peritoneal effusion requiring frequent drainage or medical intervention (clinically significant recurrence,requiring additional intervention within two weeks after intervention, excluding exfoliative cytology of exudates) within 7 days before the first dose of study drug;
- Has any condition that required systemic treatment with corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive medications within 14 days before the first dose of study drug.
- Use of Chinese herbal medicines or Chinese patent medicines with antitumor activity approved by the China National Medical Products Administration (NMPA), regardless of the type of cancer, within 14 days before the first dose of study drug
- Has been administered a live vaccine within 28 days prior to study drug administration
- Has a History of severe hypersensitivity reaction or any contraindication to any component of the tislelizumab or lenvatinib formulation or any component of the container;
- Patients with concomitant diseases that seriously jeopardize the patient's safety or affect the patient's completion of the study judged by the investigator;
- Pregnant and lactating women;
- Malabsorption syndrome or inability to take oral medications for other reasons.
Trial locations and contacts
1 site in 1 country.
Jie Zhao, Doctor contact
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Yongxiang Xia, yx_xia@njmu.edu.cn
jie Zhao, 498281113@qq.com
About this study
Official title: A Single-arm, Open-label Clinical Study of Combined Therapy of Tisleizumab , Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors
This study is a single-center, single-arm, open-label clinical study. All patients with advanced and unresectable biliary tract tumors will be treated with the combination of tisleizumab, lenvatinib and XELOX regimen (oxaliplatin plus capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. Patients will be closely monitored for safety and tolerability throughout the study.
- Conditions
- Biliary Tract Tumor
- Being tested
- Tislelizumab, Lenvatinib, Oxaliplatin, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TislelizumabDrug
Tisleizumab 200 mg intravenously (IV) every 3 weeks (Q3W) ,D1
LenvatinibDrug
Lenvatinib 8 mg (for patient weight < 60 kg) or 12 mg (for patient weight ≥ 60 kg), orally, QD, D1-21, Q3W
OxaliplatinDrug
Oxaliplatin 130 mg/m2, IV， D1，Q3W
Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years.
CapecitabineDrug
Capecitabine 1000 mg/m2, orally, BID, D1-14, Q3W
Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years.
| Study group | Role | What they receive |
|---|---|---|
| TIS combined therapy | Experimental | All patients will be treated with the combination of tisleizumab , lenvatinib and XELOX regimen (oxaliplatin combined with capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. Receives: Drug: Tislelizumab; Drug: Lenvatinib; Drug: Oxaliplatin; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) per RECIST v1.1 assessed by investigator
It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
Measured: 12months
Safety as measured by the rate of AEs
Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
Measured: 12months
Secondary outcomes (5)
ORR per iRECIST by the investigator
ORR assessed by the investigator according to iRECIST
Measured: 12months
Disease control rate (DCR)
Disease control rate (DCR) assessed by the investigator according to RECIST v1.1 and iRECIST
Measured: 12months
duration of response (DOR)
DOR assessed by the investigator according to RECIST v1.1 and iRECIST
Measured: 12months
progression-free survival (PFS)
progression-free survival (PFS) assessed by the investigator according to RECIST v1.1 and iRECIST
Measured: 12months
Overall survival (OS)
Overall survival (OS)
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start14 Feb 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract TumorStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291052
- Sponsor's protocol ID
- Tis-BTC-001
- Status last verified
- Mar 2022
- First submitted
- 14 Mar 2022
- Last updated
- 22 Mar 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 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study of Combined Therapy of Tisleizumab , Lenvatinib and XELOX Regimen (Oxaliplatin Combined With Capecitabine) in the First-line Treatment of Advanced and Unresectable Biliary Tract Tumors
- ClinicalTrials.gov ID
- NCT05291052
- Acronym / sponsor ID
- Tis-BTC-001
- Conditions
- Biliary Tract Tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 22 Mar 2022 (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 study is a single-center, single-arm, open-label clinical study. All patients with advanced and unresectable biliary tract tumors will be treated with the combination of tisleizumab, lenvatinib and XELOX regimen (oxaliplatin plus capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. Patients will be closely monitored for safety and tolerability throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TIS combined therapy | Experimental | Drug: Tislelizumab, Drug: Lenvatinib, Drug: Oxaliplatin, Drug: CapecitabineAll patients will be treated with the combination of tisleizumab , lenvatinib and XELOX regimen (oxaliplatin combined with capecitabine) until disease progression , unacceptable toxicity, death or the patient meets any other discontinuation criteria described in the protocol, whichever occurs first. Subjects can receive up to 8 cycles of the XELOX regimen. For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- To be eligible to participate in this study, a patient must meet all of the following criteria:
Key exclusion criteria (16 listed)
- To be eligible to participate in this study, a patient cannot meet any of the following exclusion criteria:
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 |
|---|---|---|
| TislelizumabTisleizumab 200 mg intravenously (IV) every 3 weeks (Q3W) ,D1 | Drug | TIS combined therapy |
| LenvatinibLenvatinib 8 mg (for patient weight < 60 kg) or 12 mg (for patient weight ≥ 60 kg), orally, QD, D1-21, Q3W | Drug | TIS combined therapy |
| OxaliplatinOxaliplatin 130 mg/m2, IV， D1，Q3W Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. | Drug | TIS combined therapy |
| CapecitabineCapecitabine 1000 mg/m2, orally, BID, D1-14, Q3W Subjects can receive up to 8 cycles of the XELOX regimen (Oxaliplatin and Capecitabine). For subjects who are intolerant to XELOX regimen or have stable disease or objective response after complete 8 cycles of XELOX regimen, treatment with tisleizumab and lenvatinib will be continued until tumor progression or for a maximum of 2 years. | Drug | TIS combined therapy |
Primary outcome
Objective response rate (ORR) per RECIST v1.1 assessed by investigator
Time frame: 12months
It is defined as the proportion of patients whose tumors shrink to a predetermined size and maintain a minimum time limit. It includes the cases of CR and PR.
Safety as measured by the rate of AEs
Time frame: 12months
Safety will be evaluated by incidence, severity and outcomes of adverse events (AEs) and categorized by severity in accordance with the NCI CTC AE Version 5.0
5 secondary outcomes
ORR per iRECIST by the investigator
Time frame: 12months
Disease control rate (DCR)
Time frame: 12months
duration of response (DOR)
Time frame: 12months
progression-free survival (PFS)
Time frame: 12months
Overall survival (OS)
Time frame: 24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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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. This study is not recruiting at the moment.
Jie Zhao, Doctor contact
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, Lenvatinib and Oxaliplatin in people with Biliary Tract Tumor, run by The First Affiliated Hospital with Nanjing Medical University 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 23 inclusion and 16 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 22 Mar 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?
Contact Yongxiang Xia, Doctor (86-025-68303211, yx_xia@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) per RECIST v1.1 assessed by investigator (time frame: 12months). The study lists 2 primary outcomes in all. 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 22 Mar 2022.