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Biliary Tract CancerPhase 2NCT05156788

Tislelizumab（Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

A Phase 2 study testing PD-1+Lenvatinib+GEMOX in people with Biliary Tract Cancer and PD-1 Antibody, run by Shanghai Zhongshan Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to assess the R0 resection rate of tislelizumab combined with Lenvatinib and Gemox chemotherapy in the conversion therapy of potentially resectable locally advanced BTC. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Biliary Tract Cancer, PD-1 Antibody, Gemox
What is being tested?
PD-1+Lenvatinib+GEMOX
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesChina
Study dates
12 Dec 2021to 1 Oct 2025
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male or female aged 18-70 2. The patient must sign an informed consent form before joining the group, understand and be willing to sign a written informed consent form 3. Potentially resectable locally advanced BTC (including ICC, PBDT and GBC) confirmed by histology or cytology, agree to provide previously stored tumor tissue specimens or fresh biopsy tumor lesions for biomarker detection 4. Local progress, failure to achieve R0 resection, and no distant metastasis, with potential resection 5. At least one measurable lesion (RECIST 1.1) 6. Have never received systemic treatment for biliary tumors in the past 7. Eastern Cooperative Oncology Group (ECOG) performance status score ECOG PS 0-1 8. Liver function classification is Child-Pugh A 9. The bone marrow, liver and kidneys are fully functional and reach the following clinical laboratory evaluation standards within 7 days before treatment:
  • Blood indicators:
  • Absolute neutrophil count (ANC) ≥ 1.5 × 109/L, platelet ≥ 90 × 109/L, hemoglobin ≥ 90 g/L.
  • Liver function indicators:
  • AST and ALT are both ≤3×ULN (upper limit of normal value); total bilirubin ≤1.5×ULN
  • Kidney function indicators:
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  • Serum creatinine≤1.5×ULN
  • Coagulation index:
  • International normalized ratio (INR) ≤ 1.2 or prothrombin time (PT) ≤ 1.2×ULN
  • Obstructive jaundice, after PTCD or ERCP treatment, if the liver function indicators meet the requirements for entry, it can be considered for entry:
  • 10. If the subject has HBV or HCV infection, the following conditions must be met:
  • For inactive/asymptomatic carriers of HBV, chronic, or active HBV:
  • HBV deoxyribonucleic acid (DNA) <2000 copies/mL during the screening period. Remarks: Patients with HBV DNA>2000 copies/mL should be treated according to treatment guidelines. Patients who received antiviral drug treatment at the time of screening should have HBV-DNA <2000 copies/mL and continue treatment during the study period.
  • For subjects infected with HCV:
  • If the infection is confirmed based on the detectable HCV ribonucleic acid RNA, such subjects cannot be included in the group.
  • 11. If you are a fertile woman (that is, physically capable of getting pregnant), you must agree to take effective contraceptive measures during the study period and within 120 days after the last administration, and have urine within 7 days before the first study drug administration Or the serum pregnancy test is negative.
  • 12. If you are a non-sterilized male, you need to agree to take effective contraceptive measures during the study period and 120 days after the last dose.
  • 13. Life expectancy ≥ 3 months

Who cannot join

  • 1. Diagnosed as mixed type of periampullary carcinoma, hepatocellular carcinoma and cholangiocarcinoma 2. Have received systemic treatment for biliary tumors in the past 3. Have previously received gemcitabine-based chemotherapy or TKI therapy or any tumor immunotherapy (for example, PD-1/L1 inhibitors, CTLA-4 inhibitors, etc.) 4. Have a history of severe hypersensitivity to other monoclonal antibodies 5. Allergy to tislelizumab or any of its excipients; allergy to oxaliplatin and any of its excipients; allergy to gemcitabine and any of its excipients; allergy to lenvatinib and any of its excipients 6. The presence of pericardial effusion, uncontrollable pleural effusion or clinically obvious ascites within 7 days before treatment is defined as meeting the following criteria: (a) Ascites can be detected by physical examination during screening, or (b) during screening, Ascites requires puncture fluid.
  • 7. There is no clinical evidence of portal hypertension with esophageal or gastric varices within 6 months before starting treatment.
  • 8. Any bleeding or thrombotic disease or any anticoagulant (such as warfarin or similar drugs) that needs to monitor the international standardized ratio during treatment within 6 months before the start of treatment 9. Has suffered from any malignant tumors, except for the BTC studied in this clinical trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast cancer) Carcinoma in situ, occult carcinoma of the thyroid).
  • 10. Any known central nervous system metastasis and/or leptomeningeal disease have been present before treatment.
  • 11. A history of any active immunodeficiency or autoimmune disease and/or any immunodeficiency or autoimmune disease that may recur at the time of screening
  • Note: Subjects with the following diseases can be selected:
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  • Type I diabetes Hypothyroidism (if only hormone replacement therapy can be used to control) Controlled celiac disease Skin diseases that do not require systemic treatment (eg vitiligo, psoriasis, hair loss) Any other disease that will not recur without external triggers 12. Any disease requiring systemic treatment with corticosteroids (dose higher than 10mg/day of prednisone or equivalent doses of similar drugs) or other immunosuppressive agents in the 14 days before treatment.
  • Remarks: Subjects who have currently or previously used any of the following steroid regimens can be selected:
  • In the absence of active autoimmune diseases, adrenaline replacement steroids are allowed (prednisone ≤10mg/day or equivalent dose of similar drugs) Local, ophthalmic, intra-articular, intranasal and inhaled corticosteroids with minimal systemic absorption Prophylactic short-term use (≤7 days) corticosteroids (for example, allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by contact allergens) 13. There is a history of interstitial lung disease or non-infectious pneumonia.
  • 14. Any serious chronic infection or active infection (excluding viral hepatitis) that requires systemic antibacterial, antifungal or antiviral therapy (such as tuberculosis) before starting treatment.
  • 15. The electrocardiogram during screening showed that the QT interval (QTc) corrected according to the heart rate (corrected according to the Fridericia method) exceeded 450 msec.
  • Note: If any patient finds that the QTc interval exceeds 450 msec during the first ECG examination, the ECG will be repeated to confirm the result.
  • 16. Any of the following cardiovascular risk factors: Cardiogenic chest pain in the 28 days before treatment, defined as moderate pain that restricts daily activities (ADL) Symptomatic pulmonary embolism occurred within 28 days before treatment A history of acute myocardial infarction occurred within 6 months before treatment.
  • Any history of heart failure reaching New York Heart Association grade III or IV within 6 months of treatment Ventricular arrhythmia of grade ≥2 occurred within 6 months before treatment Cerebrovascular accident (CVA) or transient ischemic attack (TIA) occurred within 6 months before treatment.
  • 17. Have received organ transplantation or hematopoietic stem cell transplantation (HSCT) or any major surgery within 28 days before treatment.
  • 18. Known mental or substance abuse disorders that may interfere with test compliance.
  • 19. Live vaccine has been vaccinated 28 days before treatment. Note: Seasonal influenza vaccines are generally inactivated influenza vaccines and are allowed to be used.
  • 20. Known history of human immunodeficiency virus infection (HIV) or syphilis infection.
  • 21. The history or evidence of any disease, treatment, or laboratory abnormality that may confuse the test results, interfere with the participation of the subject during the entire trial, or the main investigator believes that it does not meet the subject's best benefit.
  • 22. Currently participating in and receiving treatment, or participating in or participating in other drug or device research within 4 weeks after the first administration of the research drug.
  • 23. From the screening visit to 120 days after the last drug administration, pregnancy or breastfeeding, or expectation of pregnancy or childbirth within the planned duration of the trial.
  • 24. The investigator judges that the compliance is not good, or there are other conditions that make the patients unsuitable to participate in this trial.
  • 25. There are various medical contraindications that prevent the use of enhanced imaging (CT or MRI).
  • 26. There are surgical contraindications, and the researchers believe that it is not suitable for surgical patients.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Zhongshan hospital

    Shanghai, 200032

  • Shenzhen University General Hospital

    Shenzhen

Other trials in China

About this study

Official title: A Single-arm, Multi-center, Phase II Study of Tislelizumab, Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

The aim of this study is to assess the R0 resection rate of tislelizumab combined with Lenvatinib and Gemox chemotherapy in the conversion therapy of potentially resectable locally advanced BTC.

Read the detailed description

Translational therapy refers to methods such as chemotherapy, radiotherapy, immunotherapy, targeted and combined therapy to shrink tumors, reduce tumor biological behavior, and achieve secondary resection. The success rate of transformation depends on the objective response rate of the treatment method (Objective response rate, ORR). The latest review showed that 132 patients with unresectable ICC had undergone chemotherapy, chemoembolization, radiotherapy embolization or combination therapy, and 27 patients received downgrade resection. The research of our group using PD-1 antibody combined with lenvatinib and Gemox chemotherapy in the first-line treatment of unresectable advanced cholangiocarcinoma (NCT03951597, 2020ESMO, 2021ASCO) showed that the ORR was 80% and the disease control rate (DCR) It reached 93.3% (28/30), of which 3 cases underwent successful radical resection after downstage. These data suggest that PD1 monoclonal antibody combined with lenvatinib and Gemox chemotherapy may be an ideal conversion therapy for patients with potentially resectable advanced biliary system tumors, but there is currently no evidence-based basis.

This study explores the efficacy and safety of PD1 monoclonal antibody combined with Lenvatinib and Gemox chemotherapy in potentially resectable advanced BTC conversion therapy. It has certain clinical significance in order to increase the R0 surgical resection rate of BTC patients and improve patient survival.

Being tested
PD-1+Lenvatinib+GEMOX
Medical subject headings
Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PD-1+Lenvatinib+GEMOXDrug

    Tilelizumab 200mg, add 0.9% NS 100mL, d1 Q3W, Lenvatinib 8mg, po, qd Gemox chemotherapy: Gemcitabine 1000mg/m2 with 0.9% NS 100mL, 30 minutes, d1, 8, Q3W, + oxaliplatin 85mg/m2 with 5%GS 500mL, 2 hours, d1, Q3W

Study groups in NCT05156788
Study groupRoleWhat they receive
PD-1 antibody +Lenvatinib+GemoxExperimentalTilelizumab 200mg, d1 Q3W Lenvatinib 8mg, po, qd, Gemox chemotherapy Gemcitabine 1000mg/m2, d1, 8, Q3W, + oxaliplatin 85mg/m2 d1, Q3W
Receives: Drug: PD-1+Lenvatinib+GEMOX

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. R0 resection rate

    the ratio of the number of R0 resection cases to the total number of enrolled cases

    Measured: 24 months

Secondary outcomes (7)

  1. ORR

    The proportion of patients whose best overall response (BOR) is evaluated as achieving complete response (CR) or partial response (PR) at any time during study drug treatment

    Measured: 24 months

  2. DCR

    Proportion of patients with CR, PR and SD

    Measured: 24 months

  3. PFS

    Time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)

    Measured: 24 months

  4. OS

    The time from study treatment to the date of death of the subject, regardless of the cause of death

    Measured: 24 months

  5. CPR

    The ratio of the number of pathological complete necrosis of excised specimens to the total number of surgical resections

    Measured: 24 months

  6. MPR

    The ratio of more than 90% cases of pathological necrosis of resected specimens to the total number of surgical resections

    Measured: 24 months

  7. RFS

    Proportion of patients without tumor recurrence or metastasis after surgery

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Dec 2021
  2. Study start12 Dec 2021
  3. Primary completion3 Jul 2023
  4. Study completion1 Oct 2025 (estimated)

Resources

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
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05156788
Sponsor's protocol ID
ZSAB-TransGOLP
Status last verified
Aug 2023
First submitted
30 Sep 2021
Last updated
15 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi G, Huang X, Li X, Liang F, Gao Q, Zhang D, Lu J, Ji Y, Hu Z, Chen Y, Qiu S, Yi Y, Zhu X, Sun H, Shi Y, Peng M, Wang X, Huang C, Ding Z, He Y, Shen Y, Xu Y, Xiao Y, Hu J, Zhou J, Fan J. Conversion therapy of tislelizumab plus lenvatinib and GEMOX in unresectable locally advanced biliary tract cancer (ZSAB-TransGOLP): a multicentre, prospective, phase 2 study. Lancet Oncol. 2025 Oct;26(10):1334-1345. doi: 10.1016/S1470-2045(25)00376-6. Epub 2025 Aug 29.

    PubMed 40889502

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1+Lenvatinib+GEMOX in people with Biliary Tract Cancer and PD-1 Antibody, run by Shanghai Zhongshan Hospital at 2 sites 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 18 inclusion and 24 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 15 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05156788, which also lists 1 linked publication.

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 15 Aug 2023.

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