A Study of SHR-2524 Plus Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma

Официальное название

To Investigate the Pharmacokinetics, Safety, Tolerability and Efficacy of SHR-2524 Combined With Bevacizumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC) in an Open-label, Multicenter Phase I Clinical Trial

Обзор

This study was a multicenter, open-label phase I clinical trial. This trial will include 36 patients with advanced unresectable hepatocellular carcinoma. Blood samples were obtained during the course of treatment to measure the relative parameter. All Investigational Medicinal Products (IMP) were discontinued after the total cycle.

Вмешательства

• Препарат SHR-2524 Injection
  SHR-2524 injection.
• Препарат Bevacizumab Injection
  Bevacizumab injection.

Первичные конечные точки

• Trough serum concentrations (C21d) [Срок оценки: 0 - 21 days.]
• Area under curve from Day 0 to Day 21 (AUC0-21d) [Срок оценки: 0 - 12 days.]
• Area under curve up to 21 weeks (AUC0-21weeks) [Срок оценки: 0 - 12 weeks.]

Вторичные конечные точки (12)

• Maximum blood concentration (Cmax) [Срок оценки: About 9 months.]
• Time to peak concentration (Tmax) [Срок оценки: About 9 months.]
• Area under curve - Time curve from Time 0 to the last quantifiable time point (AUC0-t) [Срок оценки: About 9 months.]
• Area under curve - Time curve from Time 0 to Infinity (AUC0-∞) [Срок оценки: About 9 months.]
• Elimination half-life (t1/2) [Срок оценки: About 9 months.]
• Rate of clearance (CL/F) [Срок оценки: About 9 months.]
• Geometric mean of the apparent volume of distribution of the population (Vz/F) [Срок оценки: About 9 months.]
• The number and percentage of anti-drug antibody (ADA) positive participants [Срок оценки: About 9 months.]
• Adverse events (AEs) [Срок оценки: About 9 months.]
• Serious adverse events (SAEs) [Срок оценки: About 9 months.]
• Investigator - assessed objective response rate (ORR) based on RECIST v1.1 [Срок оценки: About 9 months.]
• Investigator - assessed duration of response (DoR) based on RECIST v1.1 [Срок оценки: About 9 months.]

Критерии участия

Критерии включения

• ≥ 18 years old;
• Advanced hepatocellular carcinoma (HCC) confirmed by histopathology or cytology or clinical diagnosis;
• The Barcelona clinical liver cancer stage was B or C;
• Has not previously received systemic antitumor therapy for HCC;
• At least one measurable lesion according to RECIST v1.1 criteria;
• Child-Pugh score of A or B7 ;
• ECOG score 0 -1;
• The expected survival time was ≥12 weeks;
• The major organs functioned well;
• Has signed the informed consent form.

Критерии исключения

• Hepatobiliary cell carcinoma, mixed hepatocellular carcinoma-cholangiocarcinoma, sarcomatoid hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma confirmed by histology or cytology;
• Patients with active malignant tumors other than HCC within 5 years or at the same time; Localized tumors that had been cured, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, could be enrolled;
• Previous allogeneic organ transplantation (e.g., liver transplantation);
• The current liver tumor burden is greater than 50% of the total liver volume;
• CTCAE grade 3 bleeding had occurred within 6 months or CTCAE grade 2 nongastrointestinal bleeding had occurred within 3 months before the first dose;
• Abdominal fistula, gastrointestinal perforation, or abdominal abscess within 6 months before the first dose;
• Major vascular disease had occurred within 6 months before the first dose;
• Current concomitant interstitial pneumonia or interstitial lung disease, or a previous history of interstitial pneumonia or interstitial lung disease requiring hormone therapy;
• Innate or acquired immune deficiency (such as HIV infection);
• Severe infection occurred within 28 days before the first dose.

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 · 2 центра

• Mengchao Hepatobiliary Hospital of Fujian Medical University — Фучжоу
• The First Affiliated Hospital of Guangxi Medical University — Nanning

Идентификаторы

NCT: NCT07478302 · SHR-2524-101

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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