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Kava

Patients whose inferior vena cava vascular wall is invaded according to histopathological examination.

Patients whose inferior vena cava vascular wall is not invaded according to histopathological examination.

Inferior vena cava vascular wall is invaded according to pathologic examination on the postoperative tumor thrombus/ vascular wall specimen.

Vascular wall invaded

Jiyuan Chen, MD

Zhuo Liu, Doctor

Zhuo Liu, MD

The goal of this observational study is to establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of inferior vena cava (IVC) vascular wall invasion in renal cell carcinoma (RCC) with tumor thrombus invading vascular wall.The main questions it aims to answer are:

* To establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations.
* To determine what impact does different vascular wall layer invasion make on the long-term prognosis in RCC with IVC tumor thrombus;
* To determine which layer invasion according to pathological examination make sense to clinical treatment (can significantly affect prognosis); Participants with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrence outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model will be established.

Radical nephrectomy and thrombectomy are essential surgical treatments for renal cell carcinoma (RCC) with inferior vena cava (IVC) tumor thrombus. IVC vascular wall invasion leads to higher recurrence risk and worse long-term prognosis. The diagnosis and treatment of RCC tumor thrombus with IVC vascular wall invaded are affected by prominent difficulties: First, there is a lack of the preoperative diagnostic evaluation system consisting to the postoperative histopathological examinations, which is regarded as the gold standard of vascular wall invasion, therefore hinders the development of the neoadjuvant therapy strategy and surgery plan; Besides, the pathological diagnostic criteria of IVC vascular wall adhesion or invasion is inconsistent among different centers, an accurate and systematic criteria is needed.

This study consecutively includes patients admitted in Peking University Third Hospital between January 2023 to January 2026, who were diagnosed with primary renal cell carcinoma with IVC tumor thrombus with/without vascular wall invasion, and accepted radical nephrectomy and at least one IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection). The patients with IVC vascular wall invasion/ non-invasion are divided into experimental group (invaded group) or control group (non-invaded group) respectively according to pathological examinations, in order to establish a prospective cohort with three-year follow-up. For the invaded group, micro invasion subgroup and tumor thrombus capsule subgroup analysis are conducted. The pathological characteristics of local recurrence and poor prognosis are summarized, and postoperative pathological diagnostic criteria of IVC vascular wall invasion and established. The local recurrence and distant recurrences outcomes are compared between experiment group and control group, in order to analyze the long-term influence of vascular wall invasion. Then the preoperative imaging diagnostic evaluation model were established: re-diagnose patients in two groups according to the established pathological diagnostic criteria, and divide them into truly-invaded group and truly-non-invaded group. Analyzing the preoperative abdominal ultrasound scan, contrast-enhanced ultrasonography, computed tomography (CT) and magnetic resonance imaging (MRI), thus explore the imaging characteristics of vascular wall invasion and establish the preoperative diagnostic model. This study aims at establish a preoperative imaging diagnostic model which highly consistent with the histopathological examinations, as well as a accurate and systematic pathological grading standard of IVC vascular wall invasion, therefore contribute to the development of a more accurate and effective preoperative treatment strategy and surgery plan.

Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion

Preoperative Imaging Diagnostic Evaluation Model Based on Evidence-based Pathological Diagnose Criteria for Renal Cell Carcinoma Tumor Thrombus With Inferior Vena Cava Wall Invasion

The duration from the date of diagnosis to death or last follow-up, with no restriction on the cause of death.

Clinical manifestation related to the renal carcinoma

A universal grading system for renal tumor thrombus.

TNM stage according to the preoperative imaging.

Inferior vena cava residual blood flow according to ultrasonography.

Inferior vena cava vascular wall continuity according to ultrasonography.

Whether the inferior vena cava is completely occluded according to ultrasonography.

Whether the inferior vena cava enhanced synchronization with tumor thrombus according to ultrasonography.

Whether the tumor thrombus move when breathe according to ultrasonography.

Maximum inferior vena cava anterior-posterior diameter according to CT/ MRI.

Maximun coronal inferior vena cava diameter according to CT/ MRI.

Maximum inferior vena cava anterior-posterior diameter at the renal vein ostium according to CT/ MRI.

Maximun coronal inferior vena cava diameter at the renal vein ostium according to CT/ MRI.

The presence of bland thrombus in inferior vena cava according to CT/ MRI.

The presence of tumor thrombus growing against the direction of venous return according to CT/ MRI.

Radical nephrectomy and at least one kind of IVC thrombectomy (including IVC incision only, IVC partial resection, IVC diagonal resection, and IVC segmental resection)

Histological type of the tumor according to pathological examination.

TNM stage according to pathological examination.

The deepest Inferior vane cava vascular wall layer the tumor thrombus invaded.

The duration from the date of diagnosis to death, last follow-up, or cancer recurrence.

Location and time that the metastasis occurs.

Peking University Third Hospital

Attending Doctor

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Antineoplastic Agents

Hematinics

Micronutrients

Anti-Infective Agents

Bevacizumab

Atezolizumab

Chlorotrianisene

Liver Extracts

Iodine

Cadexomer iodine

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

Immunologic Factors

TACE will be performed for the patients after randomization. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 3-7 days after the first TACE.

Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy.

TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE.

TACE can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

Iodine125 seed implantation into the PVTT was conducted 3-7 days after TACE when the results of the liver function tests were comparable to those obtained before TACE. Pre-procedural planning was conducted using a three-dimensional conformal radiation therapy treatment planning system (TPS) to determine the number of Iodine125 seeds required, the target location for implantation, the best percutaneous puncture site and the access route. The targeted zone for implantation was the tumour thrombosis in the segmental portal vein, left/right portal vein. Implantation was guided by CT, and the Iodine125 seeds were implanted into the PVTT using 18 G needles and the implantation gun that housed the Iodine125 seeds in the cartridge chamber.

I-125 Seeds Brachytherapy in PVTT

TACE: cTACE (conventional TACE) or dTACE (drug-eluting beads TACE).

Transcatheter arterial chemoembolization

Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) .

Atezolizumab plus Bevacizumab

Mingsheng Huang, M.D. & Ph.D.

Luwen Mu, M.D.

The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab/Bevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab/Bevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I/II PVTT (Based on Cheng's PVTT classification).

This is a multicenter, open-label trial, randomized controlled to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT. 234 HCC patients with branch PVTT will be enrolled in this study. The Patients will be treated with TACE-AB-I or TACE-AB using a 1:1 randomization scheme. TACE will be performed for the patients after randomization. Atezolizumab/bevacizumab (1,200 mg atezolizumab plus 15 mg/kg bevacizumab intravenously every 3 weeks) will be started at 3-7 days after the first TACE and I-125 Seeds Brachytherapy and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. For patients in the TACE-AB-I arm, iodion-125 seeds will be implanted into the PVTT (according to the pre-operative planning) under CT guidance within 3-7 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.

This is a multicenter, open-label trial, randomized controlled trial to evaluate the efficacy and safety of TACE-AB-I compared with TACE-AB for the treatment of HCC with branch PVTT.

TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT

TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial

Time from randomization to death from any cause.

Time from randomization to disease progression (mRECIST) or death from any cause, whichever occurred first.

The percentage of patients who had a best overall tumor response rating of CR and PR (mRECIST).

The time from randomization until the date that complete portal vein occlusion was confirmed (if the portal vein is patent at diagnosis).

Number of patients with AE, treatment-related AE (TRAE), AE of special interest (AESI), serious adverse event (SAE), assessed by NCI CTCAE v5.0.

Sun Yat-sen University

Fifth Affiliated Hospital, Sun Yat-Sen University

Second Affiliated Hospital of Guangzhou Medical University

Maoming People's Hospital

Shandong Provincial Third Hospital

Third Affiliated Hospital, Sun Yat-Sen University

The director of Department of Interventional Radiology

Ethiodized Oil

Estrogens

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

TACE combined with iodine-125 seeds implantation

Conventional TACE with lipiodol was performed. Then Iodine-125 seed implantation into PVTT is conducted 7-10 days after TACE when liver function tests demonstrated values comparable to those obtained before TACE.

Only conventional TACE with lipiodol and chemotherapy drugs was performed.

TACE

Kangshun Zhu, MD

Portal vein tumour thrombus (PVTT) is a common complication of hepatocellular carcinoma (HCC). PVTT has a profound adverse effect on prognosis, with a very short median survival time (2-4 months). The presence of PVTT also limits treatment options, such as liver transplantation and curative resection. Although the Barcelona Clinic Liver Cancer group recommended sorafenib as a standard therapy for advanced-stage HCC, the optimal treatment for HCC with PVTT remains largely controversial.

Some studies have reported a survival benefit in patients with PVTT who underwent transarterial chemoembolization (TACE), even in patients with main portal vein (MPV) tumor thrombus. Iodine-125 brachytherapy had also showed promising efficacy as a new method for unresectable HCC with PVTT. Results of our previous study indicated that TACE combined with Iodine-125 seeds implantation might be a good choice for selected patients with PVTT. Thus, we conduct this study to farther evaluate the effect of TACE combined with Iodine-125 seeds implantation for HCC with PVTT.

270 patients with HCC and PVTT will be included and randomized to two group: group 1, patients received TACE combined with Iodine-125 seeds implantation; group 2, patients received TACE alone. TACE and Iodine-125 seeds implantation will be performed with a standardized procedure. Iodine-125 seeds implantation into PVTT (guided by CT) will be conducted 7 days after TACE.

All patients revisit our institutions for follow-up examinations including contrast enhanced CT/MRI and laboratory tests every 4-6 weeks after the first treatment. Patients who have a tumor response rating of complete response will be required to revisit 3 months interval. At each visit, TACE or Iodine-125 seeds implantation is repeated if the following criteria are reached: 1) images indicating viable intrahepatic tumor tissue or PVTT; 2) Child-Pugh class A or B, and no contraindication to TACE and Iodine-125 seeds implantation.

The primary end point of this study is overall survival. The secondary end points are time to tumor progression, disease control rate, duration of portal patency and adverse events. All adverse events are graded in accordance with Common Toxicity Criteria Adverse Events Version (CTCAE) 4.03.

Background and purpose:

Hepatocellular carcinoma (HCC) is the 5th most common cancer in the world and the 3rd most prevalent cause of tumor-related deaths. Portal vein tumor thrombus (PVTT) occurs in up to 44% of HCC patients at the time of death and approximately 10-40% of patients at time of diagnosis. PVTT has a profound adverse effect on prognosis, with a very short median survival time (2-4 months). The presence of PVTT also limits treatment options, such as liver transplantation and curative resection. The optimal treatment for patients with HCC and PVTT remains largely controversial.

The Barcelona Clinic Liver Cancer (BCLC) group recommended the tyrosine kinase inhibitor sorafenib as a standard therapy for patients with advanced-stage HCC (BCLC stage C), including HCC patients with PVTT. However, in the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) trail, on which the BCLC recommendations were based, patients with vascular invasion represented only 38.4% of the total study population. This result may not directly imply a survival gain with sorafenib treatment in HCC patients with PVTT. Additionally, the median survival time for patients with advanced HCC, including vascular invasion or extrahepatic metastases, treated with sorafenib is short - only 6.5 months in Asia. Thus, more effective treatment strategies have been strongly required to increase survival rate.

Some studies have reported a survival benefit in patients with PVTT who underwent transarterial chemoembolization (TACE), even in patients with main portal vein tumor thrombus. Iodine-125 brachytherapy alone had also showed promising efficacy as a new method for unresectable HCC with PVTT. Results of our previous study indicated that TACE combined with Iodine-125 seeds implantation might be a good choice for selected patients with PVTT. Thus, we conduct this study to farther evaluate the effect of TACE combined with Iodine-125 seeds implantation for HCC with PVTT.

Methods:

HCC was diagnosed by biopsy or according to the non-invasive criteria following the European Association for the Study of Liver/American Association for the study of Liver Disease guidelines. The presence of PVTT was confirmed by three-phase dynamic CT or MR. The types of PVTT were classified into four subgroups: type I, PVTT in segmental branches of portal vein or above; type II, PVTT affecting left/right portal vein; type III, PVTT affecting main portal vein (MPV); and type IV, PVTT affecting superior mesenteric vein (SMV).

270 patients met the eligibility criteria will be included in this study and randomized to two group: group 1, patients received TACE combined with Iodine-125 seeds implantation; group 2, patients received TACE alone.

TACE procedure:

solution of doxorubicin hydrochloride (20-40 mg) and 5-Fu (500-1000 mg) is infused into the feeder vessels of HCC. Then, An emulsion of 2-20 ml lipiodol and 20-50 mg lobaplatin is administered into the feeder vessels. The total amount of chemotherapy drugs is depended on the patient's body weight. Finally, gelatin sponge or polyvinyl alcohol (PVA) particles, which are mixed with contrast material, were administered into the feeder vessels until stasis of arterial flow was achieved. In patients with an arterioportal shunt, embolization with 300-1000 μm PVA is performed to occlude the shunt by superselective catheterization before infusion of lipiodol and lobaplatin emulsion.

Iodine-125 seeds implantation procedure:

Iodine-125 seeds implantation into PVTT is conducted 7 days after TACE when liver function tests demonstrated values comparable to those obtained before TACE. Each particle was 4.5 mm in length and 0.8 mm in diameter, with a radioactivity of 0.6-0.8mCi, radioactive half-life of 60.1days, and radiation energy of 27.4KeV. The volume and shape of PVTT is obtained by CT/MR images and used to calculate the matched peripheral dose and determine best percutaneous access route and numbers of Iodine-125 seeds using our three dimensional conformal radiation therapy Treatment Planning System (TPS). Implantation was guided by CT and Iodine-125 seeds are implanted into inside PVTT or around the PVTT (parenchymal or tumor issue from PVTT less than 1.7 cm) 5 mm apart along the length of PVTT using 18G needles.

Follow-up and re-treatment:

All patients revisit our institution for follow-up examinations including contrast enhanced CT/MRI every 4-6 weeks after the first treatment. The laboratory tests are checked within one week before and after the first TACE or Iodine-125 seed implantation, and every 4-6 weeks during follow-up. Patients who have a tumor response rating of complete response will be required to revisit 3 months interval. At each visit, TACE or Iodine-125 seed implantation or combination of TACE and Iodine-125 seed is repeated if the following criteria are reached: 1) images indicating viable intrahepatic tumor tissue or PVTT; 2) Child-Pugh class A or B, and no contraindication to TACE and Iodine-125 seeds implantation.

TACE Combined With Iodine-125 Seeds Implantation for HCC

TACE Combined With Iodine-125 Seeds Implantation Versus TACE Alone for Hepatocellular Carcinoma With Portal Vein Tumor Thrombus: A Prospective, Multicenter, Randomized, Controlled Study

The time from date of randomization to death due to any cause.

Side effects of TACE and iodine-125 seeds implantation were reported according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03

The time from randomization until the first occurrence of PD or death due to any cause, whichever occurs first.

The time from randomization until the date that disease progression (PD) was confirmed radiologically.

The percentage of patients who had a best overall tumor response rating of CR or PR.

Tumor response was evaluated with contrast-enhanced CT or MR imaging according to the modified Response Evaluation Criteria in Solid Tumors (mRECIST) criteria. Disease control rate was defined as the percentage of patients who had a best tumor response rating of complete response (CR), partial response (PR), or stable disease (SD), which was maintained for at least 4 weeks from the first manifestation of that modified Response Evaluation Criteria Solid Tumors rating.

ZhuHai Hospital

The First People's Hospital of Zhaoqing

Foshan Sanshui District People's Hospital

Guangdong Provincial People's Hospital

Patients undergoing radical nephrectomy and inferior vena cava thrombectomy transabdominal without thoracotomy

The abdomen was accessed through a Makuuchi incision. After mobilization of the liver and assessment of the inferior vena cava infiltration (IVC), IVC was clamped below the level of the renal veins. In order to get access to the intrapericardial IVC, an incision was made through the tendon of the diaphragm and a clamp was placed first in the hepatoduodenal ligament (Pringle maneuver) and then in the endopericardial portion of the IVC, in that order. A longitudinal 3-4 cm incision was made incorporating the junction of IVC and right renal vein. After tumor removal thrombus was removed and a fine clamp was placed at the IVC just below the hepatocaval junction and immediate release of the clamping of the hepatoduodenal ligament. Total endopericardial clamp time was 4 minutes. Patients then underwent radical nephrectomy in a standard fashion with en bloc resection of the IVC thrombus.

Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy

Nikolaos Arkadopoulos, MD, PhD

Assessment of short-term outcomes of radical nephrectomy combined with IVC thrombectomy with a novel technique without thoracotomy: single center case series.

Assessment of the 30-day mortality and major complications as well as long-term oncological outcomes of three patients undergoing radical nephrectomy combined with inferior vena cava (IVC) thrombectomy with a novel technique without thoracotomy for renal cell carcinoma with IVC level IV thrombus. This is a retrospective case series carried out at Attikon University Hospital between January 2018 to March 2020.

Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus: Resection Without Thoracotomy

Resection of Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus Without Thoracotomy: A Case Series and Literature Review.

Percentage of patients' postoperative deaths

Incidence of Clavien/Dindo grade 3 or more postoperative complications

Attikon Hospital

Principal Investigator

Sorafenib

Protein Kinase Inhibitors

Enzyme Inhibitors

Transarterial chemoembolization plus external beam radiation therapy

Trans-arterial chemoembolization (TACE) every 6 weeks + external beam radiation therapy starting within 3 weeks after first TACE

TACE+External beam RT

Young-Suk Lim, MD, PhD

To evaluate and compare the efficacy and safety of sorafenib versus trans-arterial chemoembolization plus external beam radiation therapy in patients with hepatocellular carcinoma invading major intrahepatic vessels

Current practice guidelines recommend only sorafenib for patients with hepatocellular carcinoma invading major intrahepatic vessels. However, recent data from observational studies suggest that the combination of transarterial chemoembolization and external beam radiotherapy would be as effective as sorafenib.

Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion

Randomized Trial Comparing Sorafenib and Transarterial Chemoembolization Plus External Beam Radiotherapy in Patients With Hepatocellular Carcinoma Showing Macroscopic Vascular Invasion

Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons with the intention-to-treat principle.

Progression is defined as progressive disease (PD) by independent radiologic review according to RECIST criteria (version 1.1), termination of the assigned treatment, or death from any cause, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.

Radiologic response rate by independent radiologic review according to RECIST criteria (version 1.1), , assessed by Chi-square test or Fisher's exact test, as appropriate.

Crossover of treatment is permitted after confirming the disease progression during the initially assigned treatment, assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.

The median time to progression assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.

The median overall patient survival rate assessed by Kaplan-Meier analysis and log-rank test for treatment comparisons.

By using Cox proportional hazards model to evaluate the interaction between important baseline characteristics and the effect of treatments on overall survival.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Predicting Model Based on Evidence-based Pathological Diagnose Criteria for RCC Tumor Thrombus With IVC Wall Invasion	NCT05589207	Carcinoma, Rena... Tumor Thrombus Neoplasm Invasi... Inferior Vena C...	Vascular wall i...	18 Years -	Peking University Third Hospital
TACE Plus Atezolizumab/Bevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT	NCT05984511	Hepatocellular ... Hepatic Portal ... Tumor Thrombus	I-125 Seeds Bra... Transcatheter a... Atezolizumab pl...	18 Years - 75 Years	Third Affiliated Hospital, Sun Yat-Sen University
TACE Combined With Iodine-125 Seeds Implantation for HCC	NCT03322280	Hepatocellular ... Portal Vein Occ... Tumor Thrombus	TACE combined w... TACE	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University
Renal Cell Carcinoma and Stage IV Inferior Vena Cava Thrombus: Resection Without Thoracotomy	NCT04350047	Renal Cell Carc...	Radical nephrec...	18 Years -	Attikon Hospital
Sorafenib vs.TransArterial Chemoembolization Plus RadioTherapy in Hepatocellular Carcinoma With Macrovascular Invasion	NCT01901692	Hepatocellular ...	TACE+External b... Sorafenib	20 Years -	Asan Medical Center
TACE Combined With Iodine-125 Seeds Implantation for HCC	NCT03322280	Hepatocellular ... Portal Vein Occ... Tumor Thrombus	TACE combined w... TACE	18 Years - 75 Years	Second Affiliated Hospital of Guangzhou Medical University

Spots Global Cancer Trial Database for tumor thrombus