Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Digestive System Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Liver Diseases

Gastrointestinal Diseases

Hematinics

All Drugs and Chemicals

Liver Extracts

Almonertinib 110 mg，orally once a day. Patients receive Almonertinib treatment until disease progression, unacceptable toxicity or other discontinuation criteria.

Almonertinib 110mg p.o qd. Patients receive Almonertinib treatment until disease progression, unacceptable toxicity or other discontinuation criteria.

Almonertinib

Feng Luo, doctor

Yanyang Liu

Feng Luo

Zhixi Li

Jiewie Liu

Li Wang

Jiantao Wang

To assess the efficacy and safety of Almonertinib therapy in patients with abnormal liver function after first/second generation EGFR-TKI treatment, or Almonertinib first-line therapy in patients with basic hepatopathy and locally advanced or metastatic EGFR-mutant non-small cell lung cancer.

This is a single arm, open-lable, phase II clinical trial，aimed to assess the efficacy and safety of Almonertinib therapy in EGFR-mutant advanced non-small cell lung cancer patients with abnormal liver function after the first/second generation EGFR-TKI treatment or EGFR-mutant advanced non-small cell lung cancer patients with basic hepatopathy and have not received any systematic treatment. The patients meet all the inclusion criterias, and do not meet any exclusion criteria can be included, the duration of patient observation is 24 months.

Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

a Phase II Studay to Assess the Efficacy and Safety of Almonertinib Therapy in Patients With Abnormal Liver Function After First/Second Generation TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy

ORR is defined as the number of patients with at least 1 visit response of CR (Complete response) or PR (Partial response) according to RECIST 1.1.

Liver function indicators, including ALT, AST, TBIL, D-BIL, I-BIL, ALP, GGT, bile acid, ALB, GLB.

PFS is defined as the time from date of enrollment until the date of disease progression as assessed according to RECIST 1.1 or death from any cause on study.

Disease control rate (DCR) is defined as the percentage of participants with disease control best overall response (complete response, partial response or stable disease).

OS is defined as time from date of enrollment until date of death due to any cause. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.

West China Hospital

Study Chair

Blood and Lymph Conditions

Thrombocytopenia

Blood Platelet Disorders

Hematologic Diseases

Cytopenia

durg：Hetrombopag 5mg，once daily，oral

The patients received Hetrombopag 5mg orally d1-14 days, surgery will be conducted at d6-14 day

Hetrombopag

The patients received Placebo 5mg orally d1-14 days, surgery will be conducted at d6-14 day

Placebo

Lu Wang, Professor

Ti Zhang, Professor

Lu Wang, M.D.

This is a single center, randomized, controlled study, to evaluate the efficacy and safety of Herombopag in patients with Thrombocytopenia before hepatectomy.

The purpose of this study is to assess the ability of Herombopag to elevate platelet counts thereby reducing the need for platelet transfusions in patients with thrombocytopenia before hepatectomy. The clinical benefit of Herombopag will be measured by the proportion of subjects who avoid platelet transfusions, before, during and up to 7 days after undergoing an hepatectomy. In addition, bleeding events will be monitored during this time. The number of transfusions, safety events will be monitored during this time and for up to 3 months after undergoing a hepatectomy to help further evaluate clinical benefit.

Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy

Director, Department of Liver Surgery, Fudan University Shanghai Cancer Center

Platelet transfusions were administered at the discretion of the investigator and the physician performing the hepatectomy.

The World Health Organization Bleeding Scale was used to assess bleeding following surgery.. The range of possible scores is 0 to 4. Grade 0 is no bleeding; Grade 1 is petechiae (small \[1-2 millimeter\] red or purple spot on the body, caused by a minor hemorrhage); Grade 2 is mild blood loss; Grade 3 is gross blood loss (requiring a transfusion; and Grade 4 is debilitating blood loss (retinal or cerebral associated with fatality).

Platelet count were determined from blood draws. platelet count collect on baseline and prior to 1 days of surgery. Missing platelet count assessments at any given time point was considered to be a non-response at that point and were not estimated

Platelet count were determined from blood draws. platelet count collect on baseline and prior to 1 days of surgery. Missing platelet count assessments at any given time point was considered to be a non-response at that point and were not estimated.

Imaging examination will be conducted at d1、d3、d5、d7、d14、end of one month、 end of three month after surgery, to evaluate deep venous thrombosis if necessary.

Posthepatectomy liver failure is defined as: A postoperatively acquired deterioration in the ability of the liver to maintain its synthetic, excretory, and detoxifying functions, characterized by an increased international normalized ratio A postoperatively acquired deterioration in the ability of the liver to maintain its synthetic, excretory, and detoxifying functions, characterized by an increased international normalized ratio and hyperbilirubinemia on or after postoperative day 5. If international normalized ratio or serum bilirubin concentration is increased preoperatively, Post hepatectomy liver failure is defined by an increasing international normalized ratio and increasing serum bilirubin concentration on or after postoperative day 5 Other obvious causes for the observed biochemical and clinical alterations such as biliary obstruction should be ruled out. The evaluate of liver failure was conducted at d1、d3、d5、d7、d14、end of one month、 end of three month after surgery.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy	NCT05662813	Non-small Cell ...	Almonertinib	18 Years -	West China Hospital
Efficacy and Safety of Herombopag in Patients With Thrombocytopenia Before Hepatectomy	NCT05442632	Hepatopathy	Hetrombopag Placebo	18 Years -	Fudan University
Almonertinib Therapy in Patients With Abnormal Liver Function After EGFR-TKI Treatment, or Almonertinib First-line Therapy in Patients With Basic Hepatopathy	NCT05662813	Non-small Cell ...	Almonertinib	18 Years -	West China Hospital

Spots Global Cancer Trial Database for hepatopathy

Every month we try and update this database with for hepatopathy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hepatopathy

Every month we try and update this database with for hepatopathy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hepatopathy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.