Clinical trial NCT06818773: Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Metastatic Biliary Tract Cancer
HER2 Positive
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: 12 months
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 12 months
measure: Disease Control Rate (DCR)
timeFrame: 12 months
measure: Overall Survival (OS)
timeFrame: 24 months
measure: Quality of Life Questionnaire-Core 30（QLQ-C30）
timeFrame: 24months
measure: Adverse Event（AE）
timeFrame: 24 months
Other outcomes:
Locations:
Study officials:
References: