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

Naval Military Medical University (Second Military Medical University)

Status and phase

Not yet enrolling

Phase 4

Conditions

HER2 Positive

Metastatic Biliary Tract Cancer

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06818773

EC-FB-SC-09-V1.3

Details and patient eligibility

About

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.

Enrollment

35 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.