Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Colorectal Neoplasms

Liver Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Neoplastic Processes

Liver Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Central Nervous System Depressants

Hematinics

Irinotecan

Ethanol

Liver Extracts

Topoisomerase I Inhibitors

Enzyme Inhibitors

Irinotecan and polyvinyl alcohol sodium acrylate embolization microspheres（Unipearls®）

Irinotecan and HepaSphere Microspheres

Jian Lu, MD

Gao-Jun Teng, MD

This study is a prospective, multicenter, randomized controlled clinical trial to evaluate the safety and efficacy of polyvinyl alcohol sodium acrylate embolization microspheres and HepaSphere Microspheres loaded with irinotecan for the treatment of colorectal cancer with hepatic metastases through arterial chemoembolization.

This study is a prospective, multicenter, randomized controlled clinical trial. Seventy-two patients with colorectal cancer liver metastases that are not feasible or suitable for surgical resection will be enrolled in this study. The experimental group received transcatheter arterial chemoembolization (TACE) treatment with polyvinyl alcohol sodium acrylate embolization microspheres loaded with 100mg irinotecan and the control group received TACE treatment with HepaSphere Microspheres loaded with 100mg irinotecan. All patients received 1-2 TACE treatment as needed. The primary end point of this study is disease control rate (DCR) of target lesions 1 month after the last TACE treatment.

Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM

A Prospective, Multicenter, Randomized Controlled Clinical Trial on the Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for Transcatheter Arterial Chemoembolization of Colorectal Cancer Liver Metastases

Disease control rate (DCR) of target lesions 1 month after the last TACE treatment

The success rate of embolization techniques for target lesions

Disease control rate (DCR) of target lesions 1 month after first TACE treatment

Objective response rate (ORR) of target lesions 1 month after the first TACE treatment and 1 month after the last TACE treatment

Equipment performance evaluation: evaluation of conveying performance and degree of embolism

Zhongda Hospital

Professor

The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue

Radiofrequency Ablation (RFA)

chemotherapy ± target therapy

Jianmin Xu, PhD

To date no prospective trials have been completed that demonstrated whether RFA is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in overall survival compared with chemotherapy (target therapy) alone. The primary objective of this trial is to determine overall survival for patients with colorectal cancer liver metastasis are treated with radiofrequency ablation plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy only.

Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM

A Prospective, Randomized, One-center Study Assessing Overall Survival Using RFA Plus Chemotherapy ± Target Therapy and Chemotherapy ± Target Therapy Alone in Patients With Unresectable Unresectable Colorectal Cancer Liver Metastases

Fudan University

Prof.

Recurrence

Colorectal cancer treated with T cells modified with Anti-CEA-CAR T.

T cells modified with CEA targeted chimeric antigen receptor.

Anti-CEA-CAR T

Mei Wang, Medical PhD

Lin Tian, Medical PhD

Ren Zhao, Medical PhD

Chen xianze, Medical PhD

Liu Kun, Medical PhD

Shi Yiqing, Medical PhD

Wang Chen, Medical PhD

He Qianyun, Medical PhD

Mao Dongliang, Medical PhD

The main purpose of this research is to verify the safety of CEA targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.

Chimeric antigen receptor (CAR)-modified T cells have demonstrated great successes in treating even late stage cluster of differentiation antigen 19 (CD19) positive B cell malignancies. But it has few studies in solid tumors. The carcino-embryonic antigen(CEA) is widely expressed in cancers like gastric cancer, lung cancer, pancreatic cancer, breast cancer and colorectal cancer. To confirm if CAR T cells still function in solid tumors, we have developed anti-CEA CAR-modified T cells. Preclinical studies have demonstrated effective killing of CEA target cells. In this study, the CEA CARs, will be evaluated in CEA positive gastric cancer. The primary goal is to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.

A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)

A Study Evaluating the Safety and Preliminary Efficacy of Anti-CEA CAR-T Cells for the Prevention of Postoperative Recurrence and Metastasis of Stage III Colorectal Cancer or Liver Metastasis of Colorectal Cancer

Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood.

To evaluate the presence of circulating tumor cells with flow cytometry and real time PCR in patient blood.

To confirm the maximum tolerated dose of CEA targeted CAR T cells.

HuaDao (Shanghai) Biomedical Co., Ltd.

Ruijin Hospital

Director of Oncology

Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery to assess OSS and NOSS. After surgery, the HGP of tumor will be assessed by H\&E-stained sections.

Assessed boundary conditions through MRE-base SII before surgery and recorded HGP of tumor after surgery.

Magnetic Resonance Elastography and routine MRI

Yu Shi, M.D.

Yu Shi, MD

The goal of this study is to investigate the value of MR elastography-based SII as a means of detecting HGP noninvasively in patients with pathology-proven CRLM. MRE will provide a direct measure of tumor-liver adhesion to investigate the relationship between imaging findings and pathophysiological changes in the Liver.

Colorectal cancer ranks third in terms of incidence and second in terms of mortality among all cancers on the global cancer burden, based on the GLOBOCAN 2020 estimates. Among people diagnosed with colorectal cancer, 20% have metastatis, and 40% present with recurrence after previously treated localized disease. Liver is the most common site of metastasis besides lymph nodes, with a 5-year survival rate of less than 20%. Histopathological growth patterns (HGPs) appear at the interface between the tumour border and surrounding liver parenchyma which can be identified by light microscopy on tissue sections. Three primary HGPs have been identified: desmoplastic HGP (dHGP), replacement HGP and the pushing HGP. In the dHGP, the cancer cells are separated from the liver by a capsule of desmoplastic stroma in which new blood vessels are formed by sprouting angiogenesis. Recently, it has been reported that dHGP is linked to a better outcome in terms of survival and more clinical benefit achieved with preoperative anti-angiogenic therapy in patients with colorectal cancer liver metastasis (CRLM). Thus, planning of preoperative treatment might greatly benefit from HGP prediction. Preoperative prediction of HGP is challenging, however, as HGP is a histopathologic finding that can be diagnosed only with a postoperative surgical specimen. Previous studies have made many efforts to identify HGP through radiologic features (e.g., tumor margin, perilesional rim enhancement, or fused radiomics signature) by CT or MRI. However, high variability was observed in the assessment of these imaging characteristics, and they did not provide a direct measure of tumor-liver adhesion, leading to controversy in clinical practice. Recently, an MRE-based technique, termed "slip interface imaging" (SII), has been used to quantify the degree of tumor-peritumoral tissue adhesion in brain tumors and microvascular invasion in hepatocellular carcinoma noninvasively, may have the potential to characterize the mechanical characteristics of the tumor-liver interface and predict HGP of CRLM.

MRE for Assessment of Histopathological Growth Patterns in Colorectal Liver Metastases

Noninvasive Evaluation in Diagnosis and Treatment of Histopathological Growth Patterns in Colorectal Liver Metastases Using MR Elastography-based Shear Strain Mapping

Examinations were performed on a 3.0T MRI. Mechanical vibration frequencies of 30 and 60 Hz were applied in synchrony with the MRE pulse sequence. Regions of interest (ROIs) were placed manually in the liver. The performance of the use of SII to predict HGP of tumor was evaluated with the Wilcoxon rank sum, 1-way ANOVA, and Tukey-Kramer tests.

Shengjing Hospital

Deputy director of department of radiology

Bevacizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Chemotherapy regimens are determined based on the clinical experience of specialists

Chemotherapy regimens are determined based on the multimodal deep learning signature

AEM A：The specialist's decision to add bevacizumab to chemotherapy will be based on their own judgment

ARM B：The patient's PET/CT imaging, pathology, and clinical information were input into the signature, and the FOLFOX+Bevacizumab regimen was selected when the output label was 1. FOLFOXIRI chemotherapy regimen was selected when the output label was 0

Jianmin Xu, Dr.

Wenju Chang, Dr.

Establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable CRLM patients

Initially unresectable CRLM patients were included in this study. The tumor response was assessed by local MDT group. The signature will classified patients into responder or non-responder group. We will administer mFOLFOX6+bevacizumab regimen to responders, and FOLFOXIRI regimen to non-responders.

Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis

response rate will be assessed by local MDT every two months

progression free survival will be assessed by local MDT every two months during

overall survival will be assessed by researchers every two months during treatment, and telephone follow-up every three month after treatment

Head of Colorectal Surgery

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Chlorotrianisene

TACE

chemotherapy±target therapy

To date no randomized controlled trials have been completed that demonstrated whether TACE(Transarterial chemoembolization) is an effective adjunct to systemic chemotherapy (target therapy) with respect to advantages in conversion resection rates and survival compared with chemotherapy (target therapy) alone for patients who failed with first-line chemotherapy.The primary objective of this trial is to determine conversion resection rates and survival for patients with colorectal cancer liver metastasis are treated with TACE plus chemotherapy ± target therapy, compared to chemotherapy ± target therapy in the 2nd, and 3rd line.

TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)

TACE Associated With Systemic Chemotherapy Versus Systemic Chemotherapy in Patients Who Failed With First Line Chemotherapy

colorectal cancer patients at resectable stage II/III who will receive adjuvant chemotherapy after surgery

colorectal cancer patients at locally advanced stage who will receive neoadjuvant chemotherapy before surgery and adjuvant chemotherapy after surgery

colorectal cancer patients with liver metastases

Surgical resection will be performed for locoregional lesions or liver metastases.

surgical resection

Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.

adjuvant chemotherapy

Regimens of neoadjuvant chemotherapy are directed by clinical guidance and experience.

neoadjuvant therapy

Yilei Mao, MD PhD

Lejia Sun, MD

Hong Zhao, MD

Zhiying Yang, MD

Baocai Xing, MD

The therapeutic regimens of adjuvant and neoadjuvant chemotherapy for colorectal cancer (CRC) remain largely relied on clinical experience, and thus preclinical models are needed to guide individualized medicine. The investigators are going to establish 3D bioprinted CRC models and organoids from surgically resected tumor tissues of CRC patients with or without liver metastases. In vitro 3D models and organoids will be treated with the same chemotherapy drugs with the corresponding patients from whom the models are derived. The sensitivity of chemotherapy drugs will be tested in these two types of in vitro models, and the actual response to chemotherapy in patients will be evaluated. The predictive ability of 3D models for chemotherapy sensitivity in CRC patients will be compared with that of the organoids. This observational study will validate the potential value of 3D bioprinted tumor models in predicting the response to chemotherapy in CRC.

3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases

Validation of the Three-dimensional Bioprinted Tumor Models as a Predictive Method of the Response to Chemotherapy for Colorectal Cancer With or Without Liver Metastases

Individual participant data (IPD) can be accessed with reasonable requests via e-mail. IPD will be shared after the study is completed.

The response to adjuvant chemotherapy will be evaluated according to disease free survival (DFS). Regular follow-ups will be conducted, and DFS is difined as the interval between the date of surgery and the date of last follow-up or recurrence/progression.

The investigators will establish and culture 3D colorectal cancer models and organoids. The 3D models and organoids will be treated with the same chemotherapy drugs as the corresponding patients. The viability of the 3D tumor models and organoids will be observed after treatment and the IC50 of each drug will be calculated. The correlation of 3D model/organoid sensitivity and the patient response will be analyzed.

For patients who receive neoadjuvant chemotherapy before surgery, the response to neoadjuvant chemotherapy will be evaluated according to clinical imaging results and the RECIST scores.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Efficacy of Polyvinyl Alcohol Sodium Acrylate Embolization Microspheres for CRLM	NCT06021015	Colorectal Canc...	Irinotecan and ... Irinotecan and ...	18 Years - 80 Years	Zhongda Hospital
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM	NCT03127072	Colorectal Canc...	Radiofrequency ... chemotherapy ± ...	18 Years - 75 Years	Fudan University
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Unresectable CRLM	NCT03127072	Colorectal Canc...	Radiofrequency ... chemotherapy ± ...	18 Years - 75 Years	Fudan University
A Clinical Research of CAR T Cells Targeting CEA Positive Colorectal Cancer (CRC)	NCT04513431	Stage III Color... Colorectal Canc...	Anti-CEA-CAR T	18 Years - 65 Years	Ruijin Hospital
MRE for Assessment of Histopathological Growth Patterns in Colorectal Liver Metastases	NCT06208397	Metastatic Colo...	Magnetic Resona...	18 Years - 80 Years	Shengjing Hospital
Multimodal Deep Learning Signature for Evaluation of Response to Bevacizumab in Patient With Colorectal Cancer Liver Metastasis	NCT05354674	Colorectal Canc... Liver Metastase...	Bevacizumab	18 Years - 79 Years	Fudan University
TACE(Transcatheter Arterial Chemoembolization ) Associated With Systemic Chemotherapy Versus Systemic Chemotherapy Alone in Patients With Unresectable CRLM(Colorectal Liver Metastases)	NCT03783559	Colorectal Aden...	TACE chemotherapy±ta...	18 Years - 75 Years	Fudan University
3D Bioprinted Models for Predicting Chemotherapy Response in Colorectal Cancer With/Without Liver Metastases	NCT04755907	Colorectal Canc... Colorectal Canc...	surgical resect... adjuvant chemot... neoadjuvant the...	18 Years -	Peking Union Medical College Hospital

Spots Global Cancer Trial Database for colorectal cancer liver metastasis