Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring MRD Based on ctDNA

Официальное название

Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Longitudinal Monitoring Minimal Residual Disease Based on Circulating Tumor DNA

Обзор

This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.

Подробное описание

The recurrence rate of hepatocellular carcinoma after curative treatment is high, and the minimal residual disease(MRD) in patients is the major cause of liver cancer recurrence, and the MRD is an important basis for the decision of adjuvant therapy after curative treatment. Previous studies have confirmed that circulating tumor DNA(ctDNA)-MRD monitoring model can accurately predict the recurrence of hepatocellular carcinoma patients. It was also found in retrospective analysis that tumor free survival was significantly prolonged after ctDNA-positive treatment for hepatocellular carcinoma after resection. This study will conduct a prospective cohort study to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence, verify whether ctDNA-MRD longitudinal monitoring model can indicate recurrence earlier than imaging examination, and explore the feasibility of guiding adjuvant therapy after curative treatment based on this model.This study is to verify the predictive value of ctDNA-MRD longitudinal monitoring model in predicting postoperative recurrence.

Вмешательства

• Диагностический тест circulating tumor DNA
  blood sample and tissue specimen for circulating tumor DNA will be done to patient with hepatocellular carcinoma

Первичные конечные точки

• 2-year recurrence-free survival rate [Срок оценки: 2 years]

Вторичные конечные точки (1)

• Correlation between ctDNA-MRD status dynamic changes and relapse [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Male or female patients aged 18-75 years;
• Preoperative imaging examination diagnosed hepatocellular carcinoma (BCLC) stage 0 / stage A/stage B, eligible for radical surgery;
• ECOG physical status score is 0-1;
• Child-Pugh score is 5-6 points (Level A);
• Not received any anti-tumor therapy;
• Laboratory tests were at normal levels within 7 days before enrollment.

Критерии исключения

• Patient can't provide blood samples for ctDNA testing;
• Patient with two or more types of tumors at the same time;
• Non-primary liver lesions;
• Pregnant or lactating women;
• Patient with a history of other malignant tumors within the past 5 years or at the same time, except cured skin basal cell carcinoma, cervical carcinoma in situ and thyroid papillary carcinoma;
• Patient with serious heart disease;
• Other conditions deemed unsuitable for inclusion by the researcher.

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 7 центров

• The Sixth Affiliated Hospital of South China University of Technology — Foshan
• Zhujiang Hospital of Southern Medical University — Гуанчжоу
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Гуанчжоу
• Guangdong Provincial Hospital of Traditional Chinese Medicine — Гуанчжоу
• Shunde Hospital of Southern Medical University — Гуанчжоу
• Sun Yat-sen University Cancer Center — Гуанчжоу
• Yuebei People's Hospital — Shaoguan

Идентификаторы

NCT: NCT06157060 · 2023-KY-232-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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