Metastatic Biliary Tract CancerPhase 4NCT06818773
Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer
A Phase 4 study testing Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor in people with Metastatic Biliary Tract Cancer and HER2 Positive, run by Eastern Hepatobiliary Surgery Hospital.
Trial summary
To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Biliary Tract Cancer, HER2 Positive
- What is being tested?
- Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Feb 2025to 31 Dec 2027
- Phase
- Phase 4
- 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
- Males or females aged ≥18 years;
- Histologically confirmed HER2-positive metastatic biliary tract cancer;
- ECOG performance status of 0 to 1;
- No prior treatment with anti-HER2 therapies;
- Patients have not received any systemic anticancer treatment in the recurrent/metastatic setting;
- Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and/or radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;
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- Presence of at least one measurable lesion;
- Adequate function of major organs as defined by the following criteria;
- Estimated survival of ≥3 months;
- Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.
Who cannot join
- Known allergy or contraindication to any component of the study drugs;
- Previous treatment with anti-HER2 therapies;
- Prior use of immunotherapy;
- Use of immunosuppressive agents within 14 days before the first dose, except:
- Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg/day prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)
- Known active central nervous system metastases or carcinomatous meningitis;
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- Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;
- Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;
- Severe cardiac disease;
- Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;
- Neuropathy ≥ Grade I per NCI criteria;
- Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;
- History of immunodeficiency;
- Participation in another drug trial within 4 weeks before screening;
- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;
- Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Feng Xie, MD contact
About this study
Official title: Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1/PD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer
To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.
- Conditions
- Metastatic Biliary Tract Cancer, HER2 Positive
- Being tested
- Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor
- 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.
Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitorDrug
A 21-day cycle is used, with the initial dose of inetuximab at 8 mg/kg (IV), followed by 6 mg/kg (IV) on Day 1 of each subsequent cycle. Gemcitabine (1000 mg/m²) + cisplatin (25 mg/m²) are administered in combination on Day 1 and Day 8 of each cycle. The appropriate PD-1/PD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert.
| Study group | Role | What they receive |
|---|---|---|
| inetetamab+ Gemcitabine + Cisplatin ± PD-1/PD-L1 Inhibitor | Experimental | Not described Receives: Drug: Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Measured: 12 months
Secondary outcomes (5)
Progression-Free Survival (PFS)
Measured: 12 months
Disease Control Rate (DCR)
Measured: 12 months
Overall Survival (OS)
Measured: 24 months
Quality of Life Questionnaire-Core 30（QLQ-C30）
Measured: 24months
Adverse Event（AE）
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study startFeb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Biliary Tract CancerStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eastern Hepatobiliary Surgery Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Feng, Eastern Hepatobiliary Surgery Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06818773
- Sponsor's protocol ID
- EC-FB-SC-09-V1.3
- Status last verified
- Feb 2025
- First submitted
- 29 Dec 2024
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1/PD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer
- ClinicalTrials.gov ID
- NCT06818773
- Acronym / sponsor ID
- EC-FB-SC-09-V1.3
- Conditions
- Metastatic Biliary Tract Cancer, HER2 Positive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Eastern Hepatobiliary Surgery HospitalUniversity, hospital or other
- Study start
- Feb 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 10 Feb 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.
To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| inetetamab+ Gemcitabine + Cisplatin ± PD-1/PD-L1 Inhibitor | Experimental | Drug: Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males or females aged ≥18 years;
- Histologically confirmed HER2-positive metastatic biliary tract cancer;
- ECOG performance status of 0 to 1;
- No prior treatment with anti-HER2 therapies;
- Patients have not received any systemic anticancer treatment in the recurrent/metastatic setting;
Key exclusion criteria (16 listed)
- Known allergy or contraindication to any component of the study drugs;
- Previous treatment with anti-HER2 therapies;
- Prior use of immunotherapy;
- Use of immunosuppressive agents within 14 days before the first dose, except:
- Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg/day prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)
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 |
|---|---|---|
| Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitorA 21-day cycle is used, with the initial dose of inetuximab at 8 mg/kg (IV), followed by 6 mg/kg (IV) on Day 1 of each subsequent cycle. Gemcitabine (1000 mg/m²) + cisplatin (25 mg/m²) are administered in combination on Day 1 and Day 8 of each cycle. The appropriate PD-1/PD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert. | Drug | inetetamab+ Gemcitabine + Cisplatin ± PD-1/PD-L1 Inhibitor |
Primary outcome
Objective Response Rate (ORR)
Time frame: 12 months
5 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Overall Survival (OS)
Time frame: 24 months
Quality of Life Questionnaire-Core 30（QLQ-C30）
Time frame: 24months
Adverse Event（AE）
Time frame: 24 months
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 10 Feb 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.
Feng Xie, MD contact
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor in people with Metastatic Biliary Tract Cancer and HER2 Positive, run by Eastern Hepatobiliary Surgery 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 10 inclusion and 16 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 10 Feb 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Shen Feng, MD.; PhD (8616628552926, shenfengdfgd@163.com), 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: 12 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 10 Feb 2025; AzTrials last refreshed its copy on 6 Nov 2026.