Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

Официальное название

A Single-arm, Single-center Clinical Study of Iparomlimab and Tuvonralimab Injection Combined With GemOX and Lenvatinib as Conversion Therapy for Initially Potentially Resectable Intrahepatic Cholangiocarcinoma and Gallbladder Cancer

Обзор

The primary objective is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer.

Подробное описание

This single-arm, single-center clinical study aims toevaluate the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706, an Anti-PD-1/CTLA-4 Combined Antibody) combined with GemOX and lenvatinib as conversion therapy for Initially Potentially Resectable intrahepatic cholangiocarcinoma and gallbladder cancer. This study consists of three phases: screening, treatment, and follow-upEfficacy evaluation and safety monitoring should be performed throughout the study.

Вмешательства

• Препарат Iparomlimab and Tuvonralimab Injection combined with GemOX and lenvatinib
  Iparomlimab and Tuvonralimab Injection:5 mg/kg, intravenous infusion on Day 1 of each 3-week cycle (q3w); for 4 to 6 cycles. Lenvatinib: 8-12 mg, orally once daily (qd). The dose is determined by body weight:8 mg po qd for body weight \< 60 kg;12 mg po qd for body weight ≥ 60 kg GemOX Regimen: Oxaliplatin: 85 mg/m², intravenous infusion on Day 1 of each 3-week cycle (q3w); for a maximum of 6 cycles. Gemcitabine: 1000 mg/m², intravenous infusion on Day 1 and Day 8 of each 3-week cycle (q3w);

Первичные конечные точки

• R0 Resection Rate [Срок оценки: up to 12 month]

Вторичные конечные точки (6)

• Conversion Rate [Срок оценки: up to 12 month]
• Objective response rate [Срок оценки: up to 12 month]
• Progression-Free Survival [Срок оценки: up to 12 month]
• pathological Complete Response [Срок оценки: up to 12 month]
• Overall survival [Срок оценки: up to 36 month]
• Adverse Events [Срок оценки: up to 36 month]

Критерии участия

Критерии включения

• Age ≥ 18 years, male or female.
• Histologically or cytologically confirmed diagnosis of locally advanced or potentially resectable intrahepatic cholangiocarcinoma or gallbladder cancer, defined as T2b-T4 or N1 M0 according to the AJCC 8th edition.
• Expected life expectancy ≥ 12 weeks.
• No prior systemic treatment for biliary tract cancer before the first dose of study medication.
• At least one measurable lesion as defined by RECIST 1.1 criteria.
• ECOG Performance Status of 0 or 1.
• Adequate organ function, without severe dysfunction of the hematologic, cardiac, pulmonary, hepatic, renal, bone marrow, or immune systems.
• Laboratory tests meeting the following requirements: Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days before enrollment and voluntarily use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug. For men, they must be surgically sterile or agree to use adequate contraception during the observation period and for 8 weeks after the last dose of the study drug.
• Patient voluntarily participates and provides written informed consent.
• Good compliance is anticipated, allowing for efficacy and adverse event follow-up per the protocol.

Критерии исключения

• The subject has received any prior antitumor therapy or any investigational anticancer agents.
• Presence of any active autoimmune disease or a history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism \[may be enrolled if stable on hormone replacement therapy\]). Patients with childhood asthma that has completely resolved in adulthood without any intervention, or vitiligo, may be enrolled. Patients requiring medical intervention with bronchodilators are not eligible.
• Known congenital or acquired immunodeficiency, such as Human Immunodeficiency Virus (HIV) infection.
• Uncontrolled cardiac clinical symptoms or diseases, e.g., NYHA Class II or above heart failure, unstable angina, myocardial infarction within 1 year, or patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
• Severe concurrent infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungals, or antivirals), or unexplained fever >38.5°C during screening/prior to the first dose.
• Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Administration of a live attenuated vaccine within 4 weeks prior to the first dose or planned administration during the study period.
• History of or concurrent other malignant tumors within the past 5 years (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, and ovarian cancer).
• Gastrointestinal bleeding event or active hemoptysis within 28 days prior to the first dose.
• Gastric or esophageal varices requiring treatment.
• Active malignant tumors within 36 months prior to enrollment.
• Known allergy to any of the investigational drug components.
• Poorly controlled psychiatric disorder.
• Presence of superior mesenteric vein tumor thrombus, metastasis to group 16 lymph nodes, or distant metastasis to other organs / biological factors: peritoneal metastasis, direct invasion to adjacent organs, etc. / involvement of organs (pancreas, stomach, duodenum, colon) that cannot be resected en bloc.
• Any other condition deemed by the investigator as unsuitable for enrollment. This includes, but is not limited to, pre-existing central nervous system metastases, severe laboratory abnormalities, or familial/social factors that could compromise the subject's safety, or data/sample collection.
• Patients with extensive liver metastases involving the entire liver.

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

• Tianjin Medical University Cancer Institute and Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07263360 · E20251152

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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