Iparomlimab and Tuvonralimab (QL1706) for Intermediate Trophoblastic Tumors
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: QL1706, Chemotherapy.
- Кому может быть актуально
- Состояния в реестре: Intermediate Trophoblastic Tumor. Базовые параметры: 18 лет — 70 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Китай
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Efficacy and Safety of Iparomlimab and Tuvonralimab (QL1706) in the Treatment of Intermediate Trophoblastic Tumors: A Prospective, Multicenter, Single-arm Trial
Обзор
This clinical trial aims to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (QL1706), a dual-targeting immunotherapy (anti-PD-1/CTLA-4), in patients with intermediate trophoblastic tumors (ITT). The main questions it aims to answer are: Does QL1706 improve complete response (CR) rates (primary endpoint) and survival outcomes? What are the safety profiles of QL1706 in ITT, including immune-related adverse events? Participants will receive QL1706 (5 mg/kg IV, Q3W) ± chemotherapy (FAEV/EMA/EP/EMA/CO/TP-TE). They will also receive Maintenance therapy post-hCG normalization. Efficacy is assessed via serial β-hCG tests, imaging (every 9-12 weeks), and biomarker analysis.
Вмешательства
- Препарат QL1706
5 mg/kg, IV infusion, Q3W (D1) - Препарат Chemotherapy
FAEV, EMA/EP, EMA/CO, or TP/TE.
Первичные конечные точки
- Complete Response (CR) Rate [Срок оценки: up to one year]
Вторичные конечные точки (9)
- Objective Response Rate (ORR) [Срок оценки: up to one year]
- Disease Control Rate (DCR) [Срок оценки: up to one year]
- Rate of Progression-Free Survival (PFS) [Срок оценки: up to one year]
- Rate of Overall Survival (OS) [Срок оценки: up to one year]
- Concentration of anti-Müllerian hormone (AMH) to assess ovarian function [Срок оценки: up to one year]
- Number of Participants with treatment-related Adverse Events [Safety and Tolerability] [Срок оценки: up to one year]
- Quality of life of cancer patients by questionnaire [Срок оценки: up to one year]
- Cancer specific rehabilitation by questionnaire [Срок оценки: up to one year]
- Reproductive concerns after cancer by scale [Срок оценки: up to one year]
Критерии участия
Критерии включения
Females aged 18-70 years. Histologically confirmed placental site trophoblastic tumor (PSTT) or epitheloid trophoblastic tumor (ETT)
For Cohort A:
Stage IV disease (treatment-naïve）, recurrent, or chemotherapy-resistant disease
For Cohort B:
Stage I-III disease requiring adjuvant chemotherapy post-biopsy/surgery, meeting ≥1 of: Abnormal β-hCG 2 weeks post-surgery; Incomplete resection; High-risk features includes: Interval from last pregnancy ≥48 months; Deep myometrial invasion; Mitotic count >5/HPF; Tumor necrosis.
ECOG score 0-1. Signed informed consent.
Organ Function Requirements:
Hematologic:
WBC ≥3.0×10⁹/L ANC ≥1.5×10⁹/L Platelets ≥80×10⁹/L Hemoglobin ≥8.0 g/dL Creatinine ≤1.5×ULN Total bilirubin ≤1.5×ULN (or direct bilirubin ≤ULN if total bilirubin >1.5×ULN) AST/ALT ≤2.5×ULN INR/PT/aPTT ≤1.5×ULN (or within therapeutic range if on anticoagulants).
Критерии исключения
Life expectancy <3 months. Non-gestational trophoblastic tumors. Active malignancy (except if cured ≥3 years prior). Prior immune checkpoint therapy (anti-PD-1/L1, CTLA-4, ICOS, CD40, etc.) or cell-based immunotherapies.
Active autoimmune disease requiring systemic treatment (past 2 years). Exceptions: Hormone replacement (e.g., thyroxine), physiologic corticosteroids (≤10 mg/day prednisone equivalent).
Active inflammatory bowel disease (e.g., Crohn's, ulcerative colitis). Systemic corticosteroids (>10 mg/day prednisone equivalent) within 14 days. Allowed: Topical/inhaled steroids, prophylactic steroids for contrast allergy.
HIV/AIDS.
Active hepatitis:
HBV DNA >1,000 IU/mL (unless on stable antiviral therapy with DNA <1,000 IU/mL).
HCV RNA-positive (unless cured). Active tuberculosis (screening required if suspected). Uncontrolled severe infection (e.g., sepsis, pneumonia requiring hospitalization).
Cardiovascular disease: NYHA Class III/IV heart failure or LVEF <50%. Uncontrolled hypertension (≥140/90 mmHg despite treatment). Unstable angina, myocardial ischemia, or arterial thromboembolism (≤6 months).
Interstitial lung disease (history or active). Malabsorption syndromes (e.g., chronic diarrhea, bowel obstruction) or GI perforation/fistula (≤6 months).
Psychiatric/social conditions impairing consent or compliance. Allogeneic transplant history. Live vaccines ≤30 days prior to QL1706 or planned during study. Hypersensitivity to monoclonal antibodies or protocol-specified chemotherapies. Pregnancy/lactation. Other conditions deemed to compromise patient safety or study integrity.
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
Китай · 1 центр
- Peking Union Medical College Hospital — Пекин
Идентификаторы
NCT: NCT06941766 · ITT01