Neoplasms

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Sarcoma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Soft Tissue Sarcoma

Antineoplastic Agents

All Drugs and Chemicals

Lenvatinib

Protein Kinase Inhibitors

Enzyme Inhibitors

Eligible subjects with bone and soft tissue sarcoma were selected and treated with the following treatment regimens:Subjects will receive Lenvatinib mesylate capsules, 8mg (body weight ≤60kg) or 12mg (body weight \>60kg) orally once daily. Take the medicine about half an hour after meals (the time of taking the medicine should be the same as possible every day) and take it with warm water.

Lenvatinib mesylate capsule, 8mg (body weight ≤60kg) or 12mg (body weight \>60kg), orally, once daily. Take the medicine about half an hour after meals (the time of taking the medicine should be the same as possible every day) and take it with warm water.

Lenvatinib mesylate capsule

Tian Zhichao, Dr.

A total of 60 patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multi-target TKI therapy and failed were enrolled to evaluate the efficacy and safety.

To evaluate the efficacy and safety of lenvatinib mesylate capsule in patients with metastatic/surgically unresectable bone and soft tissue sarcomas who had previously received multitarget TKI therapy and failed.

Lenvatinib for Advanced Bone and Soft Tissue Sarcoma

A Multicenter, Open, One-arm Phase II Study of Ranvastinib Mesylate Capsules in the Treatment of Advanced Bone and Soft Tissue Sarcoma After Chemotherapy Failure

From the start of treatment to the onset of disease progression or death of the patient

Until the tumor progresses or the patient dies or is lost to follow-up or cannot tolerate it

Henan Cancer Hospital

associate chief physician

Digestive System Diseases

Heart and Blood Diseases

Carcinoma

Carcinoma, Hepatocellular

Thrombosis

Liver Neoplasms

Venous Thrombosis

Neoplasms, Glandular and Epithelial

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Embolism

Embolism and Thrombosis

Vascular Diseases

Hematinics

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Tislelizumab

Angiogenesis Inhibitors

Immunoglobulins

Liver Extracts

Endothelial Growth Factors

Mitogens

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Participants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a 21-day treatment cycle until \>42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until \>7 days before liver transplantation.

Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk.

Participants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a 21-day treatment cycle until \>42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until \>7 days before liver transplantation.

Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk.

intensity-modulated radiotherapy

Participants receive PD-1 Blockade (Pembrolizumab 200mg，Sintilimab 200mg， Camrelizumab 200mg，Tislelizumab 200mg) 100-200 mg intravenously on day 1 of a regular treatment cycle until \>42 days before liver transplantation or unacceptable toxicity develops. Participants receive Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily until \>7 days before liver transplantation.

Sintilimab is a recombinant anti-human PD-1 monoclonal antibody.

Sintilimab

Camrelizumab is a humanized anti-human PD-1 monoclonal antibody.

Camrelizumab

Tislelizumab is a recombinant anti-human PD-1 monoclonal antibody.

Lenvatinib (Lenvima®, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT.

Lenvatinib Mesylate Capsule

Hao Feng, MD, Ph.D

Qiang Xia, MD, Ph.D

Yong-rui Bai, MD

Xiu-mei Ma, MD

Xiao-hang Wang, MD

This is a parallel assigned, open-label, perspective trial studying the safety and efficacy of intensity-modulated radiotherapy (IMRT) combined with PD-1 Blockade and Lenvatinib for Hepatocellular Carcinoma (HCC) with Vp3 Portal Vein Tumor Thrombus (PVTT, Japanese Liver Cancer Study Group classification) before liver transplantation.

In most criteria (e.g.Milan, UCSF, Up-to-seven), PVTT remains as an absolute contraindication for liver transplant due to the high rate of recurrence and poor prognosis. Neoadjuvant therapy has induced pathological responses in multiple tumor types and might decrease the risk of postoperative recurrence in HCC. The primary endpoint is the necrosis rate of PVTT and the primary tumor.

Participants receive PD-1 Blockade (Pembrolizumab，Sintilimab， Camrelizumab，Tislelizumab) 200 mg intravenously on day 1 of a regular treatment cycle and Lenvatinib Mesylate Capsule (Lenvima®) 8 mg orally once daily. Neoadjuvant IMRT will be initiated at the third treatment cycle, and the dose prescription of IMRT is for planning target volume (PTV). The prescription dose to 95%PTV should be ≥50 Gy and ≤60 Gy, and been given in daily dose fractions of 2 Gy, 5 days per week. And the final prescription dose is determined according to dose constraints for organs at risk.

IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation

PILOT Study on the Safety and Efficacy of IMRT Combined With PD-1 Blockade and LEnvatinib as Neoadjuvant TherapY for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus (Vp3) Before Liver Transplantation（iPLENTY-pvtt）

Portal vein tumor thrombus related Response and Necrosis Rate

AFP-R is defined as a \>20% decrease in AFP serum level from baseline to the time of liver transplant, if liver transplant is not possible, the final AFP level would be measured as the AFP level at 12 months.

PFS is defined as the time from the date of treatment initiation to the date of the first observation of progressive disease (PD) by independent radiologic review according to mRECIST criteria or death from any cause.

RR is defined as the proportion of patients whose tumor volume has reached a predetermined value and can maintain a minimum time limit, including complete response(CR) and partial response(PR) by independent radiologic review according to mRECIST criteria.

TTP is defined as the duration from the date of patient recruited to the first progress at any site or the date of death from any cause.

DOR is defined as the duration from the date that measurement criteria are met for CR or PR to the first progress at any site or the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Lenvatinib for Advanced Bone and Soft Tissue Sarcoma	NCT05617859	Effectiveness Sexuality	Lenvatinib mesy...	10 Years - 70 Years	Henan Cancer Hospital
IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation	NCT05339581	Liver Cancer Liver Transplan... Hepatocellular ... Portal Vein Thr... Radiotherapy; C...	intensity-modul... Pembrolizumab Sintilimab Camrelizumab Tislelizumab Lenvatinib Mesy...	18 Years - 80 Years	RenJi Hospital
IMRT Plus PD-1 Blockade and Lenvatinib for HCC With PVTT (Vp3) Before Liver Transplantation	NCT05339581	Liver Cancer Liver Transplan... Hepatocellular ... Portal Vein Thr... Radiotherapy; C...	intensity-modul... Pembrolizumab Sintilimab Camrelizumab Tislelizumab Lenvatinib Mesy...	18 Years - 80 Years	RenJi Hospital
Lenvatinib for Advanced Bone and Soft Tissue Sarcoma	NCT05617859	Effectiveness Sexuality	Lenvatinib mesy...	10 Years - 70 Years	Henan Cancer Hospital
Lenvatinib for Advanced Bone and Soft Tissue Sarcoma	NCT05617859	Effectiveness Sexuality	Lenvatinib mesy...	10 Years - 70 Years	Henan Cancer Hospital

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