Biliary Tract CancerPhase 2NCT06993025
Ivonescimab in Combination With Liposomal Irinotecan and 5-FU/LV in Potentially Resectable Biliary Tract Malignancies
A Phase 2 study testing Ivonescimab+chemotherapy in people with Biliary Tract Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 2 sites in China.
Trial summary
This Phase II, single-arm, single-center study evaluates the conversion to resectability and safety of Ivonescimab combined with liposomal irinotecan and 5-FU/LV in patients with potentially resectable biliary tract malignancies. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Biliary Tract Cancer
- What is being tested?
- Ivonescimab+chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesChina
- Study dates
- 25 May 2025to 25 Apr 2027
- Phase
- Phase 2
- 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
- Patients eligible for inclusion in this study must meet all of the following criteria:
- Informed Consent: Able to provide written informed consent and understand and agree to comply with study requirements and the assessment schedule.
- Age and Gender: Age ≥18 years and ≤75 years on the day of signing the Informed Consent Form (ICF), male or female.
- Disease Status: Potentially resectable, previously untreated biliary tract malignancy confirmed by histological or cytological evidence.
- Tumor Assessment: Tumor evaluated by a hepatobiliary surgeon with sufficient objective evidence to determine irresectability.
- Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- Life Expectancy: Estimated survival of more than 12 weeks.
- Body Weight: Weight >30 kg.
- Prior Therapy: No prior anti-tumor therapy, including but not limited to anti-CTLA-4, anti-VEGF, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.
- EnEnough Organ Function
- Coagulation: Prothrombin time (PT) ≤1.5×ULN, international normalized ratio (INR) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN.
- Blood Pressure: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg during the screening period, with or without antihypertensive medication. No changes to antihypertensive therapy within 1 week prior to the first administration of the study drug.
- Contraception: Sexually active males and females of childbearing potential (not surgically sterilized) must agree to use a medically accepted method of contraception (e.g., intrauterine device, contraceptive pill, or condom) during the study treatment period and for 6 months after the last dose of study treatment.
- Females of childbearing potential must have a negative serum β-human chorionic gonadotropin (β-HCG) test within 7 days prior to study enrollment and must not be breastfeeding.
- HBV Management: Patients with detectable HBV DNA levels (≥10 IU/mL or above the limit of detection) and HBV infection (defined as positive hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody [anti-HBc]) must receive antiviral therapy according to clinical practice prior to study treatment to ensure adequate viral suppression. Antiviral therapy must be continued during the study period and for 6 months after the last dose of study treatment. Patients with positive anti-HBc but undetectable HBV DNA (<10 IU/mL or below the limit of detection) do not require antiviral therapy unless HBV DNA exceeds 10 IU/mL or the limit of detection during the study. Patients with active HBV and HCV co-infection (defined by positive anti-HCV antibody) or active HBV and hepatitis D virus co-infection are excluded.
- Voluntary Participation: Willing to voluntarily participate in the clinical trial, comply with study visits and procedures, understand the study requirements, and have signed the informed consent form.
Who cannot join
- Participants with any of the following conditions are not eligible for this study:
- Presence of unresectable extrahepatic metastases.
- Prior treatment for cholangiocarcinoma, including chemotherapy, molecularly targeted agents, traditional Chinese medicine with antitumor properties, radiotherapy, or interventional therapy (excluding percutaneous transhepatic cholangial drainage [PTCD] or common bile duct stenting). This also includes prior immunotherapy for cholangiocarcinoma.
- History of allogeneic organ transplantation.
- Major surgery, active ulceration, or incomplete wound healing within 1 month prior to the first administration of the study drug (excluding central venous catheter placement, tumor biopsy, or nasogastric tube insertion).
- Planned elective surgery during the study period.
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- Blood product transfusion or administration of hematopoietic colony-stimulating growth factors (e.g., G-CSF, GM-CSF, M-CSF) within 14 days prior to the first dose of the study drug.
- Live-attenuated vaccine administration within 30 days prior to the first dose of the study drug.
- Use of immunosuppressive medications within 14 days prior to the first dose. Exceptions include:
- Topical, inhaled, or intra-articular corticosteroids.
- Systemic corticosteroid doses ≤10 mg/day of prednisone or equivalent.
- Prophylactic corticosteroid use for hypersensitivity reactions (e.g., premedication for CT scans).
- Active autoimmune or inflammatory diseases, or a history thereof, including inflammatory bowel disease (e.g., colitis, Crohn's disease), diverticulitis (excluding diverticulosis), systemic lupus erythematosus, sarcoidosis, Wegener's syndrome, granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, or uveitis. Exceptions include:
- Vitiligo or alopecia.
- Stable hypothyroidism managed with hormone replacement (e.g., post-Hashimoto's thyroiditis).
- Chronic skin conditions not requiring systemic therapy.
- Celiac disease controlled by diet.
- Patients with no active disease within the past 5 years, after consultation with the study investigator.
- Uncontrolled medical conditions, including but not limited to: persistent or active infections (other than HBV or HCV), symptomatic congestive heart failure, uncontrolled diabetes, uncontrolled hypertension, unstable angina, uncontrolled arrhythmias, active interstitial lung disease, severe chronic gastrointestinal diseases with diarrhea, or psychiatric/social conditions that may limit adherence to study requirements, increase the risk of adverse events (AEs), or impair the ability to provide written informed consent.
- History of severe bleeding tendency or coagulopathy; clinically significant bleeding symptoms (e.g., gastrointestinal bleeding, hemoptysis) within 1 month prior to the first dose; or ongoing anticoagulation therapy within 10 days prior to the first dose.
- Arterial thromboembolic events within 6 months prior to the first dose, or venous thromboembolic events graded ≥Grade 3 per NCI CTCAE v5.0.
- History of another primary malignancy, except:
- Malignancies treated with curative intent, with no evidence of active disease ≥5 years prior to the first dose and a low risk of recurrence.
- Non-melanoma skin cancer or malignant melanocytic nevi with no evidence of disease.
- In situ carcinoma fully treated and with no evidence of disease.
- Active primary immunodeficiency.
- Active infections, including tuberculosis or human immunodeficiency virus (HIV 1/2 antibody positivity).
- Known hypersensitivity or allergic reaction to any component of the study drug or its excipients.
- Participation in another interventional clinical trial within 1 month prior to the first dose of the study drug.
- Thromboembolic events (arterial or venous) within 6 months prior to the first dose, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, or cerebral infarction), deep vein thrombosis, or pulmonary embolism.
- Participants or their partners who are pregnant or planning pregnancy, or participants who are breastfeeding.
- Concomitant illnesses deemed by the investigator to pose a significant risk to participant safety or interfere with study completion (e.g., severe diabetes).
- Other conditions deemed by the investigator to disqualify the participant from study enrollment.
- Conversion Success Criteria for Surgical Eligibility
- After evaluation by a surgeon, participants meeting the following criteria are considered to have achieved conversion success and are eligible for surgical treatment:
- ECOG performance status ≤1.
- No extrahepatic lesions, or extrahepatic lesions deemed resectable, with no new lesions identified during treatment.
- Tumor vascular occlusion reduced to branch vessels.
- Residual liver volume ≥40% in patients with cirrhosis or ≥30% in patients without cirrhosis after R0 resection.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
About this study
Official title: A Phase II, Open-Label, Single-Arm, Single-Center Study of Ivonescimab in Combination With Liposomal Irinotecan and 5-Fluorouracil/Leucovorin in Patients With Potentially Resectable Biliary Tract Malignancies
This Phase II, single-arm, single-center study evaluates the conversion to resectability and safety of Ivonescimab combined with liposomal irinotecan and 5-FU/LV in patients with potentially resectable biliary tract malignancies. Eligible patients receive three cycles of the combination therapy every 3 weeks, followed by surgery. Post-surgery, patients resume treatment for three more cycles and then continue with evoracizumab alone for up to 1 year. Safety is monitored through AE and SAE assessments for at least 30 and 90 days post-last dose, respectively. Biomarker exploration is also conducted in consenting patients.
Read the detailed description
This trial is a prospective, single-arm, single-center Phase II study to evaluate the success, safety, and tolerability of surgical conversion of Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV in patients with potentially resectable biliary malignancies.
The study included a screening period (no more than 28 days after subjects signed informed consent to the first treatment), a treatment period (including in-treatment visits and end-of-treatment visits), and a follow-up period (including safety visits, disease progression visits, and survival visits). After signing the informed consent, the subjects underwent a screening period within 28 days prior to the initial treatment to determine their eligibility for the study.
After the subjects signed the informed consent, the subjects who met the screening criteria were selected to receive Ivonescimab combined with irinotican liposome injection and 5-FU/LV, administered once every 3 weeks, and then given radical surgical treatment at an elective time after 3 cycles.
Successful conversion subjects resumed treatment within 8 weeks after surgery and received Ivonescimab combined with irinotecan liposome injection and 5-FU/LV every 3 weeks, and continued to receive Ivonescimab treatment for 1 year after 3 cycles.
The safety of the medication is evaluated, and depending on the severity of adverse events (AE) that occur and are associated with the drug, the investigator will take measures to ensure the safety of the subject. After the final dosing, each subject will receive at least 30 days of follow-up AE monitoring and at least 90 days of follow-up SAE monitoring to evaluate subsequent safety.
Biomarkers for predictive efficacy will also be explored, biomarker blood and tumor samples will be collected at baseline and during the trial for subjects who have signed up for biomarker sample collection/collection.
Administration regimen:
- Ivonescimab: 20mg/kg, d1, ivgtt, Q3W
- Irinotecan liposomes: 70mg/m2, d1, ivgtt, Q3W
- Calcium folinate 400mg/m2, d1, ivgtt, Q3W 4.5-FU 2400mg/m2, d1, ivgtt, Q3W
- Conditions
- Biliary Tract Cancer
- Being tested
- Ivonescimab+chemotherapy
- 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.
Ivonescimab+chemotherapyDrug
Also called Ivonescimab+Liposomal Irinotecan + 5-FU/LV
Dosing Schedule:
- Ivonescimab: 20 mg/kg, Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).
- Irinotecan Liposome: 70 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).
- Calcium Folinate (LV): 400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).
- 5-FU: 2400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).
| Study group | Role | What they receive |
|---|---|---|
| Ivonescimab+chemotherpy | Experimental | After signing informed consent, subjects who meet the inclusion criteria following screening will receive Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV, administered every 3 weeks for 3 cycles, followed by scheduled radical surgery.
Subjects who achieve successful conversion will resume treatment within 8 weeks after surgery and continue with Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV, administered every 3 weeks for 3 cycles. Subsequently, they will receive Ivonescimab monotherapy until 1 year of treatment is completed.
Dosing Schedule:
1. Ivonescimab: 20 mg/kg, Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).
2. Irinotecan Liposome: 70 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).
3. Calcium Folinate (LV): 400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W).
4. 5-FU: 2400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). Receives: Drug: Ivonescimab+chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
surgical conversion success rate
Surgical conversion success rate refers to the percentage of subjects who achieve relief after treatment and undergo surgical treatment among the evaluable cases, while also calculating the R0 resection rate and the relief situation based on postoperative pathology.
Measured: From the start of conversion therapy until surgical evaluation or resection, or until it is determined that surgical resection is not feasible.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2025
- Study start25 May 2025 (estimated)
- Primary completion25 Apr 2026 (estimated)
- Study completion25 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CancerStudies 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
- NCT06993025
- Sponsor's protocol ID
- EC-2025-004
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 28 May 2025
- 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 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Single-Arm, Single-Center Study of Ivonescimab in Combination With Liposomal Irinotecan and 5-Fluorouracil/Leucovorin in Patients With Potentially Resectable Biliary Tract Malignancies
- ClinicalTrials.gov ID
- NCT06993025
- Acronym / sponsor ID
- EC-2025-004
- Conditions
- Biliary Tract Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 25 May 2025 (estimated)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 25 Apr 2027 (estimated)
- First posted
- 28 May 2025 (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 Phase II, single-arm, single-center study evaluates the conversion to resectability and safety of Ivonescimab combined with liposomal irinotecan and 5-FU/LV in patients with potentially resectable biliary tract malignancies. Eligible patients receive three cycles of the combination therapy every 3 weeks, followed by surgery. Post-surgery, patients resume treatment for three more cycles and then continue with evoracizumab alone for up to 1 year. Safety is monitored through AE and SAE assessments for at least 30 and 90 days post-last dose, respectively. Biomarker exploration is also conducted in consenting patients.
Detailed description
This trial is a prospective, single-arm, single-center Phase II study to evaluate the success, safety, and tolerability of surgical conversion of Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV in patients with potentially resectable biliary malignancies.
The study included a screening period (no more than 28 days after subjects signed informed consent to the first treatment), a treatment period (including in-treatment visits and end-of-treatment visits), and a follow-up period (including safety visits, disease progression visits, and survival visits). After signing the informed consent, the subjects underwent a screening period within 28 days prior to the initial treatment to determine their eligibility for the study.
After the subjects signed the informed consent, the subjects who met the screening criteria were selected to receive Ivonescimab combined with irinotican liposome injection and 5-FU/LV, administered once every 3 weeks, and then given radical surgical treatment at an elective time after 3 cycles.
Successful conversion subjects resumed treatment within 8 weeks after surgery and received Ivonescimab combined with irinotecan liposome injection and 5-FU/LV every 3 weeks, and continued to receive Ivonescimab treatment for 1 year after 3 cycles.
The safety of the medication is evaluated, and depending on the severity of adverse events (AE) that occur and are associated with the drug, the investigator will take measures to ensure the safety of the subject. After the final dosing, each subject will receive at least 30 days of follow-up AE monitoring and at least 90 days of follow-up SAE monitoring to evaluate subsequent safety.
Biomarkers for predictive efficacy will also be explored, biomarker blood and tumor samples will be collected at baseline and during the trial for subjects who have signed up for biomarker sample collection/collection.
Administration regimen:
- Ivonescimab: 20mg/kg, d1, ivgtt, Q3W
- Irinotecan liposomes: 70mg/m2, d1, ivgtt, Q3W
- Calcium folinate 400mg/m2, d1, ivgtt, Q3W 4.5-FU 2400mg/m2, d1, ivgtt, Q3W
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ivonescimab+chemotherpy | Experimental | Drug: Ivonescimab+chemotherapyAfter signing informed consent, subjects who meet the inclusion criteria following screening will receive Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV, administered every 3 weeks for 3 cycles, followed by scheduled radical surgery. Subjects who achieve successful conversion will resume treatment within 8 weeks after surgery and continue with Ivonescimab in combination with irinotecan liposome injection and 5-FU/LV, administered every 3 weeks for 3 cycles. Subsequently, they will receive Ivonescimab monotherapy until 1 year of treatment is completed. Dosing Schedule: 1. Ivonescimab: 20 mg/kg, Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 2. Irinotecan Liposome: 70 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 3. Calcium Folinate (LV): 400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 4. 5-FU: 2400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients eligible for inclusion in this study must meet all of the following criteria:
Key exclusion criteria (39 listed)
- Presence of unresectable extrahepatic metastases.
- Prior treatment for cholangiocarcinoma, including chemotherapy, molecularly targeted agents, traditional Chinese medicine with antitumor properties, radiotherapy, or interventional therapy (excluding percutaneous transhepatic cholangial drainage [PTCD] or common bile duct stenting). This also includes prior immunotherapy for cholangiocarcinoma.
- History of allogeneic organ transplantation.
- Major surgery, active ulceration, or incomplete wound healing within 1 month prior to the first administration of the study drug (excluding central venous catheter placement, tumor biopsy, or nasogastric tube insertion).
- Planned elective surgery during the study period.
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 |
|---|---|---|
| Ivonescimab+chemotherapyAlso: Ivonescimab+Liposomal Irinotecan + 5-FU/LVDosing Schedule: 1. Ivonescimab: 20 mg/kg, Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 2. Irinotecan Liposome: 70 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 3. Calcium Folinate (LV): 400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). 4. 5-FU: 2400 mg/m², Day 1, intravenous infusion (ivgtt), every 3 weeks (Q3W). | Drug | Ivonescimab+chemotherpy |
Primary outcome
surgical conversion success rate
Time frame: From the start of conversion therapy until surgical evaluation or resection, or until it is determined that surgical resection is not feasible.
Surgical conversion success rate refers to the percentage of subjects who achieve relief after treatment and undergo surgical treatment among the evaluable cases, while also calculating the R0 resection rate and the relief situation based on postoperative pathology.
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 28 May 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivonescimab+chemotherapy in people with Biliary Tract Cancer, run by Tianjin Medical University Cancer Institute and 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 16 inclusion and 39 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: opening soon, as of the sponsor's last update on 28 May 2025. 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?
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 Lu chen, MD (（022）60670123-5202, tjchlhk@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
surgical conversion success rate (time frame: From the start of conversion therapy until surgical evaluation or resection, or until it is determined that surgical resection is not feasible.). 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 28 May 2025.