Neoplasms

All Conditions

Digestive System Diseases

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Carcinoma, Hepatocellular

Recurrence

Osteosarcoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Lenvatinib

Bevacizumab

Liver Extracts

Sorafenib

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

TKI (Sorafenib 400mg, bid, po or Lenvatinib 8mg, qd, po if bodyweight less than 60 kg,12mg, qd, po if bodyweight more than 60kg or Donafenib：200mg, bid, po) + bevacizumab：7.5mg/kg, infusion, Q3w

The eligible participants will start taking multi-kinase inhibitors between 4-8 weeks after liver transplantation. The choice of the specific multi-kinase inhibitor, including sorafenib, lenvatinib, or regorafenib, will be determined by the researchers based on factors such as the participant's tumor characteristics, liver function, physical condition, risk of side effects, economic status, and personal preference. The specific dosage and administration details can be found in the table provided. The maximum duration of multi-kinase inhibitor treatment will be 12 months or until any of the following conditions occur, whichever comes first: 1) The participant experiences intolerable toxic reactions that do not alleviate with dose adjustments, or 2) The participant has documented disease recurrence confirmed through imaging or withdraws from the study for other reasons.

multi-kinase inhibitors in combination with bevacizumab

haitao zhao

Haitao Zhao, Professor

1. Explore the impact of postoperative administration of multi-kinase inhibitors (including sorafenib, lenvatinib, and regorafenib) in conjunction with bevacizumab on post-transplant recurrence, overall survival, and drug safety in liver transplant recipients at high risk of recurrence in hepatocellular carcinoma.
2. The primary objective of this study is to evaluate the efficacy of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the one-year recurrence-free survival rate (1-year RFS rate).
3. The secondary objectives of this study are to assess the effectiveness and safety of multi-kinase inhibitors in combination with bevacizumab as adjuvant therapy in liver transplant recipients with hepatocellular carcinoma who present high-risk factors for recurrence, based on the following parameters: Recurrence-free survival (RFS) duration, Overall survival (OS), Two-year and three-year RFS rates, Graft survival, Quality of life evaluation (QoL), Incidence of adverse events and serious adverse events.

To investigate the effect of multikinase inhibitors (including sorafenib, lenvatinib and donafinib) combined with bevacizumab on recurrence, survival and safety in patients with hepatocellular carcinoma (HCC) at high risk of recurrence after liver transplantation.

Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation

A Randomized, Controlled, Open-label, Multi-center Clinical Trial of Multi-kinase Inhibitor Combined With Bevacizumab as Adjuvant Therapy in Patients With Hepatocellular Carcinoma and High-risk Recurrence Factors After Liver Transplantation

One-year recurrence-free survival rate (1-year RFS rate): The one-year recurrence-free survival rate represents the proportion of patients, within a specified study population, who remain free from disease recurrence for at least one year following a designated treatment or intervention.

Recurrence-free survival (RFS) duration: From randomization to the time of disease recurrence evidence or any cause-induced mortality.

Overall survival (OS): The duration from randomization to mortality caused by any underlying factors serves as a crucial metric for evaluating the impact of interventions on study participants.

Two-year and three-year RFS rates: The two-year and three-year RFS rate represents the proportion of patients, within a specified study population, who remain free from disease recurrence for at least two or three year following a designated treatment or intervention.

Graft survival: The interval between the commencement of randomization and the occurrence of graft loss is a pivotal time frame in transplantation research. In cases where patients are unaware of graft loss or when graft loss is not documented upon patient demise without confirmed graft loss, the time of graft loss is retrospectively evaluated using either the date of the last documented contact or the date of death.

Quality of life evaluation (QoL) according by FACT-Hep.

Incidence of adverse events and serious adverse events. Grade by CTCAE 5.0.

Peking Union Medical College Hospital

Neoplasm Metastasis

Bile Duct Diseases

Gallbladder Diseases

Bile Duct Neoplasms

Biliary Tract Neoplasms

Biliary Tract Diseases

Bile Duct Cancer

Biliary Tract Cancer

Gallbladder Cancer

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Regorafenib

Richard Kim, M.D.

The main purpose of this study is to see if regorafenib can help control or decrease cancer size in patients with cancer of the bile duct. Researchers also want to find out if regorafenib is safe and tolerable.

Single Agent Regorafenib in Refractory Advanced Biliary Cancers

Multi Institutional Phase II Trial of Single Agent Regorafenib in Refractory Advanced Biliary Cancers

OS will be defined as the time from starting on trial to date of death due to any cause. The final analysis will be conducted after the follow-time of the last patient exceeds 6 months.

DCR defined as Complete Response (CR) + Partial Response (PR)+ Stable Disease (SD). CR: Complete disappearance of all target and non-target lesions (with the exception of lymph nodes mentioned below); No new lesions. PR: Applies only to patients with at least one measurable lesion; Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions; No unequivocal progression of nonmeasurable disease; No new lesions. SD: Does not qualify for CR, PR, Progression or Symptomatic Deterioration.

PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

Progression - One or more of the following must occur: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline, as well as an absolute increase of at least 0.5 cm. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site.

Bayer

H. Lee Moffitt Cancer Center and Research Institute

Regorafenib is administered as monotherapy during the study. 160 mg once daily (QD) will be administered for 3 weeks on /1 week off. One cycle is 28 days.

Regorafenib: Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (\<30% fat) breakfast.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation	NCT06041490	Liver Transplan... Hepatocarcinoma Recurrent Osteo... High-Risk Cance...	multi-kinase in...	18 Years - 75 Years	Peking Union Medical College Hospital
Adjuvant Therapy for High-risk Hepatocellular Carcinoma Post Liver Transplantation	NCT06041490	Liver Transplan... Hepatocarcinoma Recurrent Osteo... High-Risk Cance...	multi-kinase in...	18 Years - 75 Years	Peking Union Medical College Hospital
Single Agent Regorafenib in Refractory Advanced Biliary Cancers	NCT02115542	Cancer of the B...	Regorafenib	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for multikinase inhibitor