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Biliary Tract CancerPhase 2ZENITHNCT07841873

Zanidatamab Combined With Liposomal Irinotecan and Capecitabine for Second-line Treatment of HER2-positive Unresectable Biliary Tract Tumors

A Phase 2 study testing Zanidatamab in people with Biliary Tract Cancer, run by Anhui Provincial Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective, multicenter, single-arm, phase II clinical study designed to explore the efficacy and safety of zanidatamab in combination with liposomal irinotecan and capecitabine as second-line therapy for HER2-positive advanced biliary tract cancer. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Biliary Tract Cancer
What is being tested?
Zanidatamab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
30 Nov 2026to 31 Dec 2030
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent: Voluntary provision of written informed consent; age ≥18 years.
  • Pathologic diagnosis: Histologically or cytologically confirmed unresectable locally advanced or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer.
  • HER2 status: HER2 positivity confirmed by immunohistochemistry and/or fluorescence in situ hybridization, defined as IHC 3+ or IHC 2+ with FISH-confirmed amplification. Local test results from each participating center will be used for eligibility screening.
  • Prior treatment:
  • Disease progression after or intolerance to a standard first-line regimen containing a programmed cell death protein 1 or programmed death-ligand 1 inhibitor.
  • No prior treatment with irinotecan, capecitabine, or any HER2-targeted therapy.
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  • Measurable disease: At least one measurable target lesion according to RECIST version 1.1.
  • Performance status: Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Life expectancy: ≥12 weeks.
  • Adequate organ function, based on test results obtained within 14 days before the first dose:
  • Hematologic function: Absolute neutrophil count ≥1.5 × 10⁹/L; hemoglobin ≥90 g/L; platelet count ≥100 × 10⁹/L.
  • Hepatic function: Total bilirubin ≤1.5 × the upper limit of normal; alanine aminotransferase and aspartate aminotransferase ≤2.5 × the upper limit of normal, or ≤5 × the upper limit of normal in patients with liver metastases.
  • Renal function: Serum creatinine ≤1.5 × the upper limit of normal or creatinine clearance ≥30 mL/min.
  • Cardiac function: Left ventricular ejection fraction ≥50%.
  • Coagulation function: International normalized ratio ≤1.5 × the upper limit of normal.
  • Contraception: Patients of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose.

Who cannot join

  • History of malignancy: Another active malignancy within the previous 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin.
  • Tumor type: Ampullary carcinoma.
  • Uncontrolled conditions:
  • Uncontrolled pleural effusion, ascites, or pericardial effusion. Patients requiring drainage only may be enrolled if there is no clinically significant reaccumulation within 3 days after drainage is discontinued.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
  • Recent treatment:
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  • Major surgery or radiotherapy within 4 weeks before the first dose.
  • Traditional Chinese medicines with an approved antitumor indication within 2 weeks before the first dose.
  • Participation in another interventional clinical study within 4 weeks before the first dose.
  • Comorbidities:
  • A history of myocardial infarction or unstable angina within 6 months before enrollment; troponin levels meeting diagnostic criteria for myocardial infarction; or clinically significant cardiac disease, including ventricular arrhythmias requiring treatment, uncontrolled hypertension, or any history of symptomatic heart failure.
  • Active infection, including hepatitis B virus, hepatitis C virus, or human immunodeficiency virus infection.
  • Patients positive for hepatitis B surface antigen must have an HBV DNA level <1,000 IU/mL and agree to receive antiviral therapy throughout the study.
  • Hepatitis C virus infection, except that the following patients are eligible: (i) patients with no history of curative antiviral therapy who have a confirmed negative viral load; or (ii) patients who completed curative antiviral therapy ≥12 weeks before enrollment and have a negative viral load.
  • Gastrointestinal conditions: Factors that may affect absorption of oral medication, such as chronic diarrhea or intestinal obstruction; or Grade ≥2 diarrhea.
  • Drug interactions: Use of strong CYP3A4 or UGT1A1 inhibitors or inducers within 3 weeks before the first dose.
  • Adverse reactions: Toxicities from prior therapy that have not recovered to Grade ≤1, except alopecia and peripheral neuropathy of Grade ≤2.
  • History of a life-threatening hypersensitivity reaction to monoclonal antibodies, recombinant proteins, or any excipient in the zanidatamab formulation.
  • Women who are pregnant or breastfeeding, and women or men planning to conceive a child.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

gang wang contact

+8613855196707

wanggang829@126.com

About this study

Official title: Zanidatamab Combined With Liposomal Irinotecan and Capecitabine for Second-line Treatment of HER2-positive Unresectable Biliary Tract Tumors: A Multicenter, Single-arm, Phase II Clinical Study

This is a prospective, multicenter, single-arm, phase II clinical study designed to explore the efficacy and safety of zanidatamab in combination with liposomal irinotecan and capecitabine as second-line therapy for HER2-positive advanced biliary tract cancer. Fifteen patients with unresectable locally advanced or metastatic biliary tract cancer, including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, or gallbladder cancer, will be enrolled after progression on or intolerance to first-line therapy. HER2 positivity must be confirmed by immunohistochemistry and/or fluorescence in situ hybridization, defined as IHC 3+ or IHC 2+ with FISH-confirmed amplification. Zanidatamab 20 mg/kg will be administered intravenously on Day 1 every 2 weeks; liposomal irinotecan 50 mg/m² will be administered intravenously over 90 minutes on Day 2 every 2 weeks; and capecitabine 1,000 mg/m² will be administered orally twice daily on Days 1-10 of each 14-day cycle. Chemotherapy will be administered for a maximum of six cycles, and study treatment will continue until disease progression or unacceptable toxicity. The primary endpoint is objective response rate, as assessed according to Response Evaluation Criteria in Solid Tumors version 1.1. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, and safety.

Being tested
Zanidatamab
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.

  • ZanidatamabDrug

    Also called liposomal irinotecan, capecitabine

    Zanidatamab 20 mg/kg will be administered intravenously on Day 1 every 2 weeks; liposomal irinotecan 50 mg/m² will be administered intravenously on Day 2 every 2 weeks; and capecitabine 1,000 mg/m² will be administered orally twice daily on Days 1-10 of each 14-day cycle. Chemotherapy will be administered for a maximum of six cycles, and study treatment will continue until disease progression or unacceptable toxicity.

Study groups in NCT07841873
Study groupRoleWhat they receive
TreatmentExperimentalNot described
Receives: Drug: Zanidatamab

What is being measured

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

  1. Objective response rate as assessed by RECIST v 1.1

    Measured: 24 months

Secondary outcomes (5)

  1. Disease control rate as assessed by RECIST v1.1

    Measured: 24 months

  2. duration of response as assessed by RECIST v1.1

    Measured: 24 months

  3. progression-free survival as assessed by RECIST v1.1

    Measured: 24 months

  4. overall survival

    Measured: 48 months

  5. Adverse Events as Assessed by CTCAE v5.0

    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 posted25 Sep 2026
  2. Study start30 Nov 2026 (estimated)
  3. Primary completion30 Jun 2028 (estimated)
  4. Study completion31 Dec 2030 (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
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07841873
Sponsor's protocol ID
2026KY1293
Acronym
ZENITH
Status last verified
Sep 2026
First submitted
20 Sep 2026
Last updated
1 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Zanidatamab in people with Biliary Tract Cancer, run by Anhui Provincial Hospital.

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 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: opening soon, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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 gang wang (+8613855196707, wanggang829@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate as assessed by RECIST v 1.1 (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 NCT07841873.

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 1 Oct 2026.

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