Biliary Tract Neoplasms ImmunotherapyPhase 2NCT06362317
Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer
A Phase 2 study testing Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC） in people with Biliary Tract Neoplasms Immunotherapy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Neoplasms Immunotherapy
- What is being tested?
- Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2024to 6 Mar 2026
- 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
- The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
- They are over 18 years of age and gender is not restricted when signing the informed consent form.
- They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- Patients who are diagnosed with unresectable or metastatic disease and have not received prior treatment are eligible for inclusion.
- Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant therapy (chemotherapy and/or radiotherapy) and have been disease-free for more than 6 months after completing adjuvant therapy are eligible for inclusion.
- They have at least one measurable lesion (as defined by RECIST 1.1, the measurable lesion is a spiral CT scan long diameter ≥10mm or lymph node short diameter ≥15mm).
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- Their ECOG score is 0-1 in the week prior to enrollment.
- Based on the investigator's assessment, their estimated survival time is ≥3 months.
- Patients with active hepatitis B or C require relevant antiviral treatment, with HBV-DNA <2000 IU/ml (<104 copies/ml), and have received at least 14 days of antiviral treatment before participating in the study. HCV RNA-positive patients must follow local standard treatment guidelines for antiviral therapy, and their liver function is within CTCAE Grade 1 elevation.
- Their hematological and organ functions are adequate, based on laboratory test results obtained within 14 days before the start of the study (unless otherwise specified):
- Hematology: (no blood transfusion, no G-CSF, no drug correction within 14 days prior to screening) Hb ≥90 g/L; neutrophil count ≥1.5×109/L; PLT≥100×109/L.
- Biochemistry: (no albumin transfusion within 14 days) Appropriate liver function: ALT and AST ≤2.5×ULN; for patients with liver metastases, ALT and AST ≤5 × ULN. Serum bilirubin ≤2.0×ULN; these conditions do not apply to patients with confirmed Gilbert's syndrome. Any clinically significant biliary obstruction should be resolved before randomization. Appropriate renal function: creatinine ≤1.5×ULN, or creatinine clearance rate (CCr) >50mL/min (using the standard Cockcroft-Gault formula): Female: CrCl = ((140 - age) x weight (kg) x 0.85) / 72 x serum creatinine (mg/ dL) Male: CrCl = ((140 - age) x weight (kg) x 1.00) / 72 x serum creatinine (mg/ dL)
- Women of childbearing potential: agree to abstain from sexual intercourse or use contraceptive methods with a failure rate of less than 1% during the treatment period and for at least 6 months after the last dose. If a female patient has menstruation and has not reached menopause (continuous absence of menstruation for ≥12 months without other reasons), and has not undergone sterilization surgery (removal of ovaries and/or uterus), she is considered to be of childbearing potential. Examples of contraceptive methods with a failure rate of less than 1% include bilateral tubal ligation, male sterilization, hormone-based contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual restraint should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar day, ovulation period, symptom temperature, or post-ovulation method) and ejaculation outside the vagina are unacceptable contraceptive methods.
- Male: agree to abstain from sexual intercourse or use contraceptive measures, agree not to donate sperm, as defined below: When the female partner is of childbearing potential, male patients must abstain during the treatment period and for 6 months after the last dose, or use a condom plus other contraceptive methods to achieve a failure rate of less than 1%. Male patients must also agree not to donate sperm during the same period. When the female partner is already pregnant, male patients must abstain or use a condom to prevent fetal exposure to the study during the treatment period and for 6 months after the last dose. The reliability of sexual restraint should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar day, ovulation period, symptom temperature, or post-ovulation method) and ejaculation outside the vagina are unacceptable contraceptive methods.
Who cannot join
- Previous systemic treatment received.
- ECOG score > 1. Pancreatic cancer. Pregnant (positive pregnancy test before medication) or breastfeeding women. Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs, lenvatinib and its components (or any excipients).
- Received local anti-tumor treatment within 4 weeks before the first study drug treatment, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection (allowing palliative radiotherapy for bone metastases at least 2 weeks before study drug treatment).
- Previous or existing grade 3 or higher gastrointestinal fistula or non gastrointestinal fistula (such as skin) according to CTCAE 5.0 criteria.
- Multiple factors affecting oral administration of lenvatinib (such as inability to swallow, chronic diarrhea and intestinal obstruction, or other conditions that significantly affect drug intake and absorption).
- Major surgery (except biopsy) has been performed within 4 weeks before the first study drug treatment, or the surgical incision has not completely healed; minor surgery (such as simple excision, biopsy, etc.) was performed within 7 days before the first study intervention.
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- Significant cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, cerebrovascular accidents or transient ischemic attacks within 6 months before enrollment, congestive heart failure (New York Heart Association classification ≥2), arrhythmia requiring antiarrhythmic drugs (except beta blockers or digoxin), and repeated electrocardiogram showing QTc interval >480 milliseconds (ms). Hepatic or renal dysfunction, with manifestations such as jaundice, ascites, and/ or bilirubin >3×ULN, creatinine ratio >3.5g/24 hours, or renal failure requiring blood or peritoneal dialysis, and/or urinary routine showing urine protein ≥++ or confirmed 24-hour urine protein quantification >1.0g.
- Persistent infection > grade 2 (CTCAE 5.0). History of thrombotic events (including stroke and/or transient ischemic attacks) within the past 6 months.
- Poorly controlled hypertension (systolic blood pressure >160mmHg, diastolic blood pressure >100mmHg) despite treatment with antihypertensive medications. Active autoimmune disease or history of autoimmune disease within the past 2 years; participants with active, known, or suspected autoimmune diseases that may affect important organ function or require systemic immunosuppressive therapy are excluded, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome associated with thrombosis, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. However, participants with type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, or alopecia) or participants who will not relapse without external triggering factors are allowed.
- Replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
- Known active central nervous system (CNS) metastasis and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate as long as they are stable (evidence of no progression on imaging at least 4 weeks before the first trial treatment and any neurological symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not used steroids for at least 7 days before trial treatment. This exception does not include carcinomatous meningitis, which is excluded regardless of clinical stability. Participants with known or untreated brain metastases or epilepsy requiring medication are also excluded. Planned or prior organ or allogeneic bone marrow transplantation. Known history of active tuberculosis (Mycobacterium tuberculosis). History of gastrointestinal bleeding within the past 6 months or clear evidence of gastrointestinal bleeding tendencies, such as bleeding esophageal varices, locally active gastrointestinal ulcerative lesions, fecal occult blood ≥(++), cannot be included; if fecal occult blood (+), gastroscopy is required; evidence or history of bleeding mechanism disorders of grade ≥3 (CTCAE 5.0), or other bleeding disorders.
- Known human immunodeficiency virus (HIV) infection. Known active hepatitis B or C infection and not receiving regular treatment. During the screening period, HBV DNA ≥2000 IU/ml (or ≥104 copies/ ml) must be reduced to <2000 IU/ml (or <104 copies/ml) with entecavir before enrollment. For eligible participants with Anti-HBc (+)/HBsAg (+)/ HBV DNA< 2000 IU/ml or Anti-HBc (+)/HBsAg (-)/HBV DNA< 2000 IU/ ml, antiviral therapy must be administered during the trial period using the original medication or entecavir or tenofovir.
- Severe non-healing wounds, ulcers, or fractures. History of substance abuse or any medical, psychological, or social condition that may affect the study, patient compliance, or endanger patient safety.
- Unresolved toxicity of grade >1 (CTCAE 5.0) caused by any prior treatment/procedure, except for hair loss, anemia, and hypothyroidism.
- Severe non-healing wounds, ulcers, or fractures. Objective evidence of severe pulmonary impairment, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, or drug-related pneumonia.
- Treatment with a strong CYP3A4 inhibitor (e.g., clarithromycin, indinavir, itraconazole, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole, etc.) within 7 days before participating in the study, or treatment with a strong CYP3A4 inducer (e.g., phenytoin, phenobarbital, primidone, carbamazepine, rifampin, rifabutin, rifapentine, or St. John's Wort) within 12 days before participating in the study.
- Concomitant malignancy, except for previously treated skin basal cell carcinoma, squamous cell carcinoma, carcinoma in situ of the breast or cervix, superficial bladder cancer that has been treated, and prostate cancer that has been treated with surgery and has a normal range of PSA tumor markers, or any other malignancy that has not been cured within the past 5 years.
- The investigator determines that the participant is unsuitable for the study based on overall medical condition.
- Concurrent participation in another clinical study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital (CAMS&PUMCH)
Beijing, Beijing Municipality, 100005
Haitao Zhao, Professor, +861069156042, zhaoht@pumch.cn
About this study
Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers
- Conditions
- Biliary Tract Neoplasms Immunotherapy
- Being tested
- Toripalimab, Lenvatinib, Gemox Chemotherapy（Gemox or GC）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Toripalimab 240mg, intravenous infusion every 3 weeks until disease progression or occurrence of intolerable toxicity.
LenvatinibDrug
When the body weight is ≥60 kg, the dosage of Lenvatinib is 12mg qd, when body weight < 60kg the dosage is 8mg qd.
Gemox Chemotherapy（Gemox or GC）Drug
Chemotherapy drugs: GC regimen is preferred, and if patients cannot tolerate it, GEMOX regimen is used.
Gemcitabine + oxaliplatin (GEMOX) regimen chemotherapy: every 21 days (3 weeks), 1000 mg/m2 of gemcitabine was administered intravenously for more than 30 min on the 1st and 8th day, and 100 mg/m2 of oxaliplatin was administered intravenously for 2h on the 1st day Gemcitabine + cisplatin (GC) regimen chemotherapy: 1250 mg/m2 was administered intravenously for 30 min on day 1 and day 8, respectively, and 100 mg/m2 was administered intravenously for 2 hours after gemcitabine treatment on day 1.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC） | Experimental | Not described Receives: Drug: Toripalimab; Drug: Lenvatinib; Drug: Gemox Chemotherapy（Gemox or GC） |
| Toripalimab and Lenvatinib | Experimental | Not described Receives: Drug: Toripalimab; Drug: Lenvatinib |
| Toripalimab and Gemox Chemotherapy（Gemox or GC） | Active comparator | Not described Receives: Drug: Toripalimab; Drug: Gemox Chemotherapy（Gemox or GC） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Objective response rate
Measured: Baseline up to approximately 6 months
Secondary outcomes (5)
Disease control rate (DCR)
DCR refers to the proportion of patients whose tumor volume control (shrinkage or enlargement) reaches a predetermined value and can maintain the minimum required duration. According to the RECIST criteria (version 1.1), during the treatment period or within 30 days after the discontinuation of the investigational drug, it is the sum of the percentage of subjects who achieve complete response (CR), partial response (PR), and stable disease (SD)
Measured: Baseline up to approximately 6 months
Progression-free survival (PFS)
It refers to the time from the first administration of the regimen to the first occurrence of disease progression or death due to any cause in the subjects.
Measured: Baseline up to approximately 12 months
Overall survival
The time from randomization to death due to any cause in the subjects
Measured: Baseline up to approximately 12 months
Duration of response
It refers to the time from the first report of objective tumor partial or complete response (based on the earlier occurrence) to the first occurrence of disease progression or death in the subjects
Measured: Baseline up to approximately 12 months
Clinical benefit rate
The ratio of subjects who achieve complete response (CR) or partial response (PR) or maintain stable disease (SD) .
Measured: Baseline up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start6 Mar 2024
- Primary completion6 Mar 2025 (estimated)
- Study completion6 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract Neoplasms ImmunotherapyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362317
- Sponsor's protocol ID
- K5247
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab With or Without Lenvatinib or Chemotherapy in First-Line Treatment of Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06362317
- Acronym / sponsor ID
- K5247
- Conditions
- Biliary Tract Neoplasms Immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- 6 Mar 2025 (estimated)
- Study completion
- 6 Mar 2026 (estimated)
- First posted
- 12 Apr 2024 (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.
Explore the impact of the first-line application of Toripalimab with or without Lenvatinib or chemotherapy, on the survival, disease progression, and drug safety of patients with advanced biliary tract cancers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC） | Experimental | Drug: Toripalimab, Drug: Lenvatinib, Drug: Gemox Chemotherapy（Gemox or GC） |
| Toripalimab and Lenvatinib | Experimental | Drug: Toripalimab, Drug: Lenvatinib |
| Toripalimab and Gemox Chemotherapy（Gemox or GC） | Active comparator | Drug: Toripalimab, Drug: Gemox Chemotherapy（Gemox or GC） |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The subjects voluntarily participate in the study and agree to sign the informed consent form, are compliant, and cooperate with follow-up.
- They are over 18 years of age and gender is not restricted when signing the informed consent form.
- They have histologically confirmed unresectable advanced or metastatic biliary tract adenocarcinoma, including intrahepatic or extrahepatic cholangiocarcinoma and gallbladder cancer.
- Patients who are diagnosed with unresectable or metastatic disease and have not received prior treatment are eligible for inclusion.
- Patients who have undergone curative surgery and experienced disease recurrence after more than 6 months; or patients who have completed adjuvant therapy (chemotherapy and/or radiotherapy) and have been disease-free for more than 6 months after completing adjuvant therapy are eligible for inclusion.
Key exclusion criteria (19 listed)
- Previous systemic treatment received.
- ECOG score > 1. Pancreatic cancer. Pregnant (positive pregnancy test before medication) or breastfeeding women. Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs, lenvatinib and its components (or any excipients).
- Received local anti-tumor treatment within 4 weeks before the first study drug treatment, including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic artery infusion, radiofrequency ablation, cryoablation, or percutaneous ethanol injection (allowing palliative radiotherapy for bone metastases at least 2 weeks before study drug treatment).
- Previous or existing grade 3 or higher gastrointestinal fistula or non gastrointestinal fistula (such as skin) according to CTCAE 5.0 criteria.
- Multiple factors affecting oral administration of lenvatinib (such as inability to swallow, chronic diarrhea and intestinal obstruction, or other conditions that significantly affect drug intake and absorption).
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 |
|---|---|---|
| ToripalimabToripalimab 240mg, intravenous infusion every 3 weeks until disease progression or occurrence of intolerable toxicity. | Drug | Toripalimab and Gemox Chemotherapy（Gemox or GC）, Toripalimab and Lenvatinib, Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC） |
| LenvatinibWhen the body weight is ≥60 kg, the dosage of Lenvatinib is 12mg qd, when body weight < 60kg the dosage is 8mg qd. | Drug | Toripalimab and Lenvatinib, Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC） |
| Gemox Chemotherapy（Gemox or GC）Chemotherapy drugs: GC regimen is preferred, and if patients cannot tolerate it, GEMOX regimen is used. Gemcitabine + oxaliplatin (GEMOX) regimen chemotherapy: every 21 days (3 weeks), 1000 mg/m2 of gemcitabine was administered intravenously for more than 30 min on the 1st and 8th day, and 100 mg/m2 of oxaliplatin was administered intravenously for 2h on the 1st day Gemcitabine + cisplatin (GC) regimen chemotherapy: 1250 mg/m2 was administered intravenously for 30 min on day 1 and day 8, respectively, and 100 mg/m2 was administered intravenously for 2 hours after gemcitabine treatment on day 1. | Drug | Toripalimab and Gemox Chemotherapy（Gemox or GC）, Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC） |
Primary outcome
Objective response rate (ORR)
Time frame: Baseline up to approximately 6 months
Objective response rate
5 secondary outcomes
Disease control rate (DCR)
Time frame: Baseline up to approximately 6 months
Progression-free survival (PFS)
Time frame: Baseline up to approximately 12 months
Overall survival
Time frame: Baseline up to approximately 12 months
Duration of response
Time frame: Baseline up to approximately 12 months
Clinical benefit rate
Time frame: Baseline up to approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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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.
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 Toripalimab, Lenvatinib and Gemox Chemotherapy（Gemox or GC） in people with Biliary Tract Neoplasms Immunotherapy, run by Peking Union Medical College 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 14 inclusion and 19 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 12 Apr 2024. 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 Haitao Zhao, PhD (+86-1069156042, zhaoht@pumch.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) (time frame: Baseline up to approximately 6 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 12 Apr 2024.