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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: 12 months]

Вторичные конечные точки (5)

• Progression-Free Survival (PFS) [Срок оценки: 12 months]
• Disease Control Rate (DCR) [Срок оценки: 12 months]
• Overall Survival (OS) [Срок оценки: 24 months]
• Quality of Life Questionnaire-Core 30（QLQ-C30） [Срок оценки: 24months]
• Adverse Event（AE） [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06818773 · EC-FB-SC-09-V1.3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗