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Not yet recruiting NCT06818773

Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer

Phase IV Interventional Metastatic Biliary Tract Cancer HER2 Positive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor.
Who it may be relevant to
Registry conditions: Metastatic Biliary Tract Cancer, HER2 Positive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor
    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.

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: 12 months]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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;
  • 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.

Exclusion criteria

  • 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;
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06818773 · EC-FB-SC-09-V1.3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗