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Biliary Tract Cancer (BTC)Phase 2NCT07854600

A Phase II Study of Ivonescimab in Combination With GEMOX as Neoadjuvant and Conversion Therapy for Biliary Tract Cancer

A Phase 2 study testing Ivonescimab and GEMOX Regimen in people with Biliary Tract Cancer (BTC), run by Haitao Zhao, MD at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to explore the efficacy and safety of Ivonescimab in combination with GEMOX chemotherapy as neoadjuvant and conversion therapy for patients with biliary tract cancer. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Biliary Tract Cancer (BTC)
What is being tested?
Ivonescimab and GEMOX Regimen
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteChina
Study dates
Oct 2026to Dec 2029
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Subjects voluntarily participate in the study, agree to sign a written informed consent form, demonstrate good compliance, and are willing to cooperate with follow-up.
  • 2. Male or female aged >= 18 and <= 80 years at the time of signing the ICF.
  • 3. Histologically or cytologically confirmed biliary tract cancer (BTC, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, and gallbladder cancer), and radiologically assessed as locally advanced or with oligometastases (defined as Stage IIIA or higher lesions according to the 8th edition of the AJCC staging system). Subjects must agree to provide archived or fresh tumor biopsy specimens and peripheral blood samples for biomarker testing.
  • 4. Lesion assessment meets one of the following conditions:
  • Neoadjuvant Therapy Cohort: The tumor is graded as locally advanced with no distant metastasis, and theoretically can achieve radical resection through complex resection combined with vascular reconstruction, but both the surgical risk and postoperative recurrence risk are high (single tumor diameter > 5 cm; imaging suggests vascular invasion or hilar lymph node metastasis; tumor number > 3 or any single tumor > 3 cm; preoperative CA19-9 > 37 U/mL or exceeding the upper limit of normal [applicable to centers where the normal range is not < 37 U/mL]).
  • Conversion Therapy Cohort: The tumor is graded as locally advanced, unresectable, or combined with oligometastatic status (oligometastasis is defined as: metastatic lesions confined to a single organ or specific regional lymph nodes, and the number of metastatic lesions is <= 5), with the possibility of achieving radical resection of the primary lesion and no evidence of disease (NED) status for metastatic lesions after comprehensive treatment.
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  • 5. At least one measurable lesion (according to RECIST v1.1 criteria, the longest diameter of the measurable lesion on spiral CT scan >= 10 mm or the shortest diameter of enlarged lymph nodes >= 15 mm).
  • 6. No prior systemic therapy for biliary tract cancer.
  • 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.
  • 8. Child-Pugh class A liver function.
  • 9. Normal bone marrow, liver, and kidney function, meeting the following clinical laboratory evaluation criteria within 7 days prior to treatment (the conditions cannot be met by administering any blood components, cell growth factors, albumin, or other corrective medications within 14 days prior to obtaining the laboratory tests; patients developing obstructive jaundice after percutaneous transhepatic cholangial drainage [PTCD] or endoscopic retrograde cholangiopancreatography [ERCP] treatment may be considered for enrollment if liver function indicators meet the inclusion criteria):
  • Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelet count >= 90 x 10^9/L, hemoglobin >= 90 g/L; AST and ALT <= 3 x ULN (upper limit of normal); TBil <= 1.5 x ULN;
  • Hemoglobin > 9 g/dL without blood transfusion or use of erythropoietin within the past 14 days;
  • Serum creatinine <= 1.5 x ULN and creatinine clearance rate (calculated using Cockcroft-Gault formula) >= 60 ml/min;
  • Good coagulation function, International Normalized Ratio (INR) <= 1.2 or Prothrombin Time (PT) <= 1.2 x ULN;
  • Normal thyroid function, defined as Thyroid Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or FT3) and FT4 within the normal range are also eligible;
  • Myocardial enzyme spectrum within the normal range (isolated laboratory abnormalities judged by the investigator to have no clinical significance are also permitted).
  • 10. Subjects with previous or current Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection must have received standard antiviral therapy, and the investigator must confirm that the current liver disease status is stable and suitable for receiving the study treatment.
  • 11. Women of childbearing potential: agree to use effective contraceptive methods during the study period and for 120 days after the last dose, and have a negative urine or serum pregnancy test within 7 days prior to the first dose.
  • 12. Men: agree to use effective contraceptive methods during the study period and for 120 days after the last dose.

Who cannot join

  • 1. Diagnosed with mixed periampullary cancer, or mixed hepatocellular-cholangiocarcinoma.
  • 2. Prior systemic anti-tumor therapy for BTC.
  • 3. Prior treatment with gemcitabine-based chemotherapy, platinum-based chemotherapy, or any tumor immunotherapy/targeted therapy (e.g., PD-1/PD-L1 inhibitors, VEGF inhibitors, etc.).
  • 4. History of severe allergy to other monoclonal antibodies. Known severe allergy or intolerance to gemcitabine, platinum drugs, or any of their components/excipients.
  • 5. Known allergy or intolerance to recombinant humanized PD-1 monoclonal antibody drugs, VEGF monoclonal antibody drugs, and their components (or any excipients), or a history of severe allergy to other monoclonal antibodies.
  • 6. Pericardial effusion, uncontrollable pleural effusion, or clinically significant ascites within 7 days prior to treatment, defined as meeting the following criteria: (a) ascites detectable by physical examination during the screening period, or (b) ascites requiring therapeutic paracentesis during the screening period.
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  • 7. Clinical evidence of portal hypertension with esophageal or gastric varices within 6 months prior to the start of treatment.
  • 8. Any bleeding or thrombotic disorders within 6 months prior to the start of treatment, or currently taking any anticoagulants (e.g., warfarin or similar drugs) requiring monitoring of the International Normalized Ratio (INR) during treatment.
  • 9. History of any malignant tumor, except for the BTC studied in this clinical trial and cured locally recurrent cancers (e.g., resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer or breast cancer in situ, occult thyroid cancer).
  • 10. Known central nervous system metastasis and/or leptomeningeal disease prior to treatment.
  • 11. History of any active immunodeficiency or autoimmune disease, and/or any immunodeficiency or autoimmune disease that may relapse at the time of screening.
  • 12. Any severe chronic or active infection (except viral hepatitis) requiring systemic antibacterial, antifungal, or antiviral therapy (e.g., tuberculosis) prior to the start of treatment.
  • 13. Electrocardiogram (ECG) during screening shows a heart rate-corrected QT interval (QTc) (corrected using Fridericia's formula) exceeding 450 milliseconds. Note: If the QTc interval exceeds 450 milliseconds on the first ECG, a repeat ECG will be performed to confirm the result.
  • 14. Presence of any of the following cardiovascular risk factors: cardiogenic chest pain within 28 days prior to treatment, defined as moderate pain limiting activities of daily living (ADL); symptomatic pulmonary embolism within 28 days prior to treatment; acute myocardial infarction within 6 months prior to treatment; history of New York Heart Association (NYHA) Class III or IV heart failure within 6 months prior to treatment; Grade >= 2 ventricular arrhythmia within 6 months prior to treatment; cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months prior to treatment.
  • 15. Organ transplantation or hematopoietic stem cell transplantation (HSCT) or any major surgery within 28 days prior to treatment.
  • 16. Known psychiatric or substance abuse disorders that may interfere with cooperation in the trial.
  • 17. Receipt of live vaccine within 28 days prior to treatment. Note: Seasonal influenza vaccines are generally inactivated influenza vaccines and are permitted.
  • 18. Known history of Human Immunodeficiency Virus (HIV) infection or syphilis infection.
  • 19. Any history of disease, treatment, or laboratory abnormalities that, in the opinion of the principal investigator, may confound the test results, interfere with the subject's participation throughout the trial, or are not in the best interest of the subject.
  • 20. Currently participating in and receiving treatment in another drug or device study, or having participated in such studies within 4 weeks prior to the first dose of the study drug.
  • 21. Pregnant or breastfeeding from the screening visit to 120 days after the last dose, or expecting to conceive or give birth within the planned duration of the trial.
  • 22. Poor compliance as judged by the investigator, or presence of other conditions making the patient unsuitable to participate in this trial.
  • 23. Presence of multiple medical contraindications making it unsuitable to undergo contrast-enhanced imaging (CT or MRI) examinations.
  • 24. Presence of surgical contraindications; patients deemed unsuitable for surgery by the investigators.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Haitao Zhao, DR contact

+86-10-69156042

zhaoht@pumch.cn

China1 site, 1 recruiting

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

    Beijing, Beijing Municipality, 100730

    Haitao Zhao, DR, +86-10-69156042, zhaoht@pumch.cn

    Recruiting

Other trials in China

About this study

Official title: A Single-Arm, Multi-Cohort, Phase II Study of Ivonescimab in Combination With GEMOX Chemotherapy as Neoadjuvant and Conversion Therapy for Biliary Tract Cancer

The purpose of this study is to explore the efficacy and safety of Ivonescimab in combination with GEMOX chemotherapy as neoadjuvant and conversion therapy for patients with biliary tract cancer. It aims to evaluate the impact of this combination regimen on postoperative recurrence, patient survival, and medication safety.

This is a single-center, phase II, interventional, single-arm, multi-cohort clinical study. A total of 87 eligible participants will be enrolled and assigned to either the neoadjuvant therapy cohort (45 participants) or the conversion therapy cohort (42 participants).

Being tested
Ivonescimab, GEMOX Regimen
Keywords
Ivonescimab, Neoadjuvant Therapy, Conversion Therapy, Biliary Tract Cancer, GEMOX Regimen
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.

  • IvonescimabDrug

    Also called AK112

    Administered at a dose of 20 mg/kg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W) in combination with GEMOX chemotherapy for 3 to 6 cycles. For eligible patients in the conversion therapy cohort who do not undergo surgery after evaluation, Ivonescimab is continued as maintenance monotherapy (20 mg/kg, IV, Q3W, Day 1) until disease progression, unacceptable toxicity, death, withdrawal of consent, or investigator decision.

  • GEMOX RegimenDrug

    Also called Gemcitabine and Oxaliplatin

    The GEMOX regimen consists of Gemcitabine (1000 mg/m²) and Oxaliplatin (100 mg/m²). Both drugs are administered via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). This chemotherapy regimen is administered in combination with Ivonescimab for 3 to 6 cycles prior to surgical evaluation.

Study groups in NCT07854600
Study groupRoleWhat they receive
Ivonescimab + GEMOXExperimentalParticipants in both the neoadjuvant therapy cohort and the conversion therapy cohort belong to this single experimental arm. All participants will receive 3 to 6 cycles of Ivonescimab in combination with GEMOX chemotherapy prior to surgical evaluation.
Receives: Drug: Ivonescimab; Drug: GEMOX Regimen

What is being measured

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

  1. R0 Resection Rate

    The proportion of participants in the neoadjuvant therapy cohort who undergo surgical resection and achieve microscopically margin-negative (R0) resection.

    Measured: Up to 6 weeks post-surgery

  2. Objective Response Rate

    The proportion of participants in the conversion therapy cohort achieving a Complete Response (CR) or Partial Response (PR) based on RECIST v1.1 criteria as assessed by investigators.

    Measured: Up to 24 weeks (assessed after 3-6 cycles of treatment)

Secondary outcomes (9)

  1. Objective Response Rate

    The proportion of participants in the neoadjuvant cohort achieving CR or PR based on RECIST v1.1.

    Measured: Up to 10 weeks from baseline (assessed pre-operatively)

  2. R0 Resection Rate

    The proportion of participants in the conversion cohort who achieve resectability and obtain an R0 resection post-surgery.

    Measured: Up to 4 weeks post-surgery (assessed upon availability of postoperative pathology report)

  3. Pathological Response Rate

    The proportion of participants who achieve Major Pathological Response (MPR) or Pathological Complete Response (pCR) confirmed by postoperative pathology.

    Measured: Up to 4 weeks post-surgery

  4. Disease Control Rate

    The proportion of participants achieving CR, PR, or Stable Disease (SD) based on RECIST v1.1.

    Measured: Up to 19 weeks from baseline (assessed pre-operatively)

  5. Incidence and Severity of Adverse Events

    Incidence of AEs, Serious Adverse Events (SAEs), drug-related AEs, and specific AEs assessed per NCI CTCAE v5.0. This includes continuous monitoring of vital signs and laboratory parameters.

    Measured: Up to 28 days after the last dose of study treatment

  6. Event-Free Survival

    The time from study enrollment to the first occurrence of disease progression precluding surgery, local/regional recurrence after surgery, distant metastasis, or death from any cause.

    Measured: Up to 24 months

  7. Progression-Free Survival

    The time from study enrollment of the conversion therapy cohort to the first documented objective tumor progression per RECIST v1.1 or death from any cause.

    Measured: Up to 24 months

  8. Relapse-Free Survival

    The time from surgical resection to the first occurrence of disease recurrence (local, regional, or distant) or death from any cause among patients who underwent surgery.

    Measured: Up to 24 months

  9. Overall Survival

    The time from study enrollment to death from any cause.

    Measured: Up to 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 posted2 Oct 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2028 (estimated)
  4. Study completionDec 2029 (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
87 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07854600
Sponsor's protocol ID
XH-LW-2026-007
Status last verified
Sep 2026
First submitted
24 Sep 2026
Last updated
2 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ivonescimab and GEMOX Regimen in people with Biliary Tract Cancer (BTC), run by Haitao Zhao, MD 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 20 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?

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 Haitao Zhao, DR (+86-10-69156042, zhaoht@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0 Resection Rate (time frame: Up to 6 weeks post-surgery). 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?

On the ClinicalTrials.gov record for NCT07854600.

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 2 Oct 2026.

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