Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Carcinoma, Hepatocellular

Liver Neoplasms

Ischemia

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hematinics

All Drugs and Chemicals

Liver Extracts

Active RIC using a manual BP cuff to inflate to 200mmHg.

A sham control using a manual blood pressure cuff visually identical to that used in the RIC protocol will be placed on the upper arm and a simulated RIC protocol will be administered.

Active RIC

Sham Control

Jin Yao Teo

Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.

Liver resection has improved health outcomes in patients with hepatocellular carcinoma (HCC) in Singapore and worldwide. However, due to acute ischaemia/reperfusion injury (IRI) to the liver at the time of surgery, patients still experience significant morbidity and mortality. Therefore, novel therapies are required to protect the liver against acute IRI during partial hepatectomy. Remote ischaemic conditioning (RIC) using transient limb ischaemia/reperfusion has been shown to protect the liver in experimental animal studies. In the ERIC-LIVER trial the investigators investigate whether RIC can reduce liver injury and preserve liver function in patients with HCC undergoing partial hepatectomy.

50 patients with HCC undergoing partial hepatectomy will be randomised to receive either RIC (four-5 minute arm cuff inflations/deflations) or sham control (four-5 minute arm cuff simulated inflations/deflations) after induction of anesthesia and prior to surgical incision. The primary endpoint of the study will be acute liver injury assessed by serum transaminases measured at 24 hours post-resection. Secondary endpoints will include liver function in subset of patients (N=24, assessed by indocyanine green \[ICG\] clearance measured at 24 hours post-resection), incid ence of liver failure, episodes of confirmed sepsis, acute kidney injury, intensive care unit and hospital stay, and quality of life.

Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery

Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery: The ERIC-LIVER Trial

serum ALT as a measure of acute liver injury

serum AST as a measure of acute liver injury

Liver function as assessed by the ICG retention test. Testing is optional

Assessed by checking liver histology of the resected specimen

Measure of acute kidney injury based on rise in serum creatine on day 3 post op

Duke-NUS Graduate Medical School

Singapore General Hospital

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Acute Kidney Injury

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Acute Graft Versus Host Disease

Central Nervous System Depressants

Anesthetics

Four cycles of upper arm ischemia/reperfusion

Placement of a blood pressure cuff around upper arm without inflation.

After induction of anesthesia, RIPC consisted of four 5-min cycles of limb ischemia induced by a blood pressure cuff placed on the upper arm and inflated to 250 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated.

Remote Ischemic Preconditioning

After induction of anesthesia, sham control consisted of the placement of a blood pressure cuff on the upper arm with no inflation during the surgery.

Sham control

Won Ho Kim, MD, PhD

This study is intended to evaluate the renal protective effect of Remote Ischemic Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction and prior to the surgery, while the other half will not receive this treatment as a control group.

Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion injury to target organs by a brief episode of ischemia-reperfusion of the limb. The protective effect of RIPC on major organs has been demonstrated in an animal study, but its clinical efficacy has not yet been established.

The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect of RIPC can be expected. There have been many reports of renal protective effects of RIPC in cardiac and vascular surgery. On the other hand, few studies have investigated the effect of RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the surgery.

In this study, the investigators will evaluate the effect of RIPC in patients undergoing partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.

A prospective, randomized, parallel group, controlled study

Participants, care providers, investigators and outcome assessors will be blinded to group allocation.

The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy

The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy : A Randomized Controlled Trial

Postoperative serum creatinine levels as an index of kidney damage

The incidence of AKI according to the serum creatinine diagnostic criteria of Kidney Disease Improving Global outcomes (KDIGO) Clinical Practice Guideline for AKI

eGFR is obtained by the formula of Isotope Dilution Mass Spectrometry (IDMS) Modification of Diet in Renal Disease (MDRD).

Renal rSO2 of the contralateral kidney of the operated side is monitored with Near-infrared spectroscopy.

Glomerular filtration rate measured by technetium diethylene triamine pentacetic acid (99mTc-DTPA) radionuclide scintigraphy

Seoul National University Hospital

Clinical Associate Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Immunoglobulins

Anti-MUC1 CAR-T cells will be prepared ex vivo and infused back to the patients.

Anti-MUC1 CAR-T cells and PD-1 knockout Engineered T cells will be prepared ex vivo and infused back to the patients.

PD-1 knockout Engineered T cells will be prepared ex vivo and infused back to the patients.

Patients will be treated with a FDA approved monoclonal antibody for an identical course of treatment. This group will serve as PD-1 antibody treated group.

Patient's T cells will be separate without genetic or engineered modification ex vivo and infused back to the patients.

Using the T cells from the patients to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.

CAR-T Cells

Using the T cells from the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients

CAR-T combining PD-1 Knockout

Using the T cells from the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients

PD-1 knockout

Patients will be treated with an identical course with a FDA approved monoclonal antibody against PD-1

PD-1 mAb

Patient's T cell will treated ex vivo with modification and then infused back in a similar time course.

Guobiao Huang

Size Chen, MD,PhD

Zhizhou Huang, MSc

Yiguang Lin, MD, PhD

Size Chen, MD, PhD

Micheal Yin, PhD

The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer.

This is a combined phase 1 and 2 clinical study. The study is to assess the safety and efficacy of the anti-MUC1 CAR T cells and /or PD-1 knockout engineered T cells for patients with advanced non-small cell lung cancer. The treatment outcomes will be compared.

Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC

A Clinical Study of Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for Patients With Advanced Non-small Cell Lung Cancer

Safety and tolerability of dose of CART-cells and PD-1 Knockout T cells will be assessed using CTCAE v4.0.

Will be assessed according to the revised RECIST guideline v1.1

Measure the time from enrollment to death

Time from enrollment to date of first documented progression or date of death.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery	NCT03594929	Hepatocellular ...	Active RIC Sham Control	21 Years -	Singapore General Hospital
Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery	NCT03594929	Hepatocellular ...	Active RIC Sham Control	21 Years -	Singapore General Hospital
The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy	NCT03273751	Renal Neoplasm Renal Injury	Remote Ischemic... Sham control	20 Years -	Seoul National University Hospital
Effect of Remote Ischaemic preConditioning on Liver Injury in Patients Undergoing LIVER Resection Surgery	NCT03594929	Hepatocellular ...	Active RIC Sham Control	21 Years -	Singapore General Hospital
Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLC	NCT03525782	Lung Neoplasm M... Non-small Cell ...	CAR-T Cells CAR-T combining... PD-1 knockout PD-1 mAb Sham control	18 Years - 70 Years	The First Affiliated Hospital of Guangdong Pharmaceutical University

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