Table 2.
Clinical transformation of patient-derived liver cancer organoids
| First Submitted | Identifier | Status | Enrollment | Title | Trial Aim | Biospecimen | Primary Outcome Measures |
|---|---|---|---|---|---|---|---|
| 2023/10/5 | NCT06077591 | Not Yet Recruiting | 40 | Prospective Clinical Validation of Next Generation Sequencing (NGS) and Patient-Derived Tumor Organoids (PDO) Guided Therapy in Patients With Advanced/ Inoperable Solid Tumors | Evaluating the efficacy of NGS/PDO-guided treatment in patients with inoperable or metastatic solid tumors. |
1.Hepatocellular carcinoma 2. Colorectal cancer |
1. Tumor response, partial or complete (> 30% reduction in tumor size). [Time Frame: 6 months] |
| 2023/6/27 | NCT05932836 | Recruiting | 165 | An Organoid-on-chips Technique Based on Biopsy Samples and Its Efficacy in Predicting the Response to HAI in HCC | Establishing an organoid-on-chips technological system based on biopsy samples and evaluating its efficacy in predicting the response to mFOLFOX6 infusion in patients with HCC. |
1. Breast cancer 2. Lung cancer 3. Liver cancer 4. Bile duct cancer 5. Pancreatic cancer |
1. Success rate of organoid culture of biopsy samples. The number of successful cases of organoid cultures is divided by the number of enrolled cases. [Time Frame: 2 years] 2. Accuracy of Organoid drug sensitivity test in predicting the response to mFOLFOX6 infusion in HCC patients with successful organoid culture. The sensitivity and specificity of drug sensitivity test in patients with successful organoid culture to predict the response (mRECIST) to mFOLFOX6 infusion in HCC. [Time Frame: 3 years] |
| 2023/6/13 | NCT05913141 | Recruiting | 30 | PDO/PDO-TIL/PDOTS for Drug Screen | Using the patient-derived organoid (PDO), Patient-derived organoids-tumor-infiltrating lymphocyte co-culture (PDO-TIL), and patient-derived organotypic tissue spheroids (PDOTS) systems to simulate the tumor microenvironment in patients with cancer. |
1. Liver cancer 2. Metastatic liver cancer |
1. Objective response rate (ORR) evaluated by researchers based on the RECIST 1.1 standard. [Time Frame: 1 year] |
| 2022/11/30 | NCT05644743 | Not Yet Recruiting | 40 | Clinical Transformation of Organoid Model to Predict the Efficacy of GC in the Treatment of Intrahepatic Cholangiocarcinoma | First, relevant organoids were constructed from puncture samples of unresectable ICC patients. Second, based on the intrahepatic cholangiocarcinoma organoid model, the clinical efficacy of GC regimens was predicted and in vitro and in vivo drug screening was performed to explore the significance of patient-derived tumor organoids in guiding clinical treatment. Then, the multi-omics data of organ tissues and in vitro and ex vivo drug efficacy evaluation models were used to explore the drug resistance genes of intrahepatic cholangiocarcinoma, which provided the basis for individualized drug screening and efficacy evaluation of intrahepatic cholangiocarcinoma. | 1. Intrahepatic cholangiocarcinoma |
1. Consistency of organoids and clinical patient responses to drugs. A total of 20 unresectable ICC patients were selected, and biopsies were performed before treatment to construct organoid models. All patients were treated with GC chemotherapy. Drug responses of organoids and clinical patients were compared to determine the feasibility of in vitro organoid culture as a drug screening platform. The samples of 3 patients who were sensitive to GC and 3 patients who were resistant to GC were sequenced to search for drug-resistant genes, and the differential drug-resistant genes were studied in vitro. [Time Frame: 3 years] 2. Construction of a drug resistance prediction model. A total of 20 patients with advanced unresectable ICC were selected to verify whether they participated in drug resistance by combining 1–2 drug resistance genes previously screened and the currently recognized platinum-based drug resistance genes. The results were compared with those of organoid models to build an organoid-based drug resistance prediction model. [Time Frame: 3 years] |
| 2022/5/17 | NCT05384184 | Recruiting | 48 | Next Generation " Pre-clinical Model for Colorectal Cancer Metastases and Hepatocellular Carcinomas (BORG) | Evaluating the feasibility of building a biobank of liver-derived organoids, from liver metastases of colorectal cancers, hepatocellular adenoma, and adenocarcinoma (waste tissues). |
1. Colorectal cancer metastases 2. Hepatocellular carcinomas |
1. Build the next-generation biobank of liver-derived organoids. Grow and store organoids derived from liver biopsies (HCC and CRC mets). [Time Frame: 2 years] |
| 2022/1/24 | NCT05242237 | Recruiting | 300 | Prognostic Value of Liver Cancer CTCs Isolated by a Novel Microfluidic Platform | Exploring in vitro cultures of CTCs by organoid culture or spheroid culture to obtain CTC cell lines to reveal the mechanism of HCC metastasis. |
1. Hepatocellular carcinoma 2. Circulating tumor cell |
1. Time to progression or death (months) after initial diagnosis will be recorded. [Time Frame: 2 years] |
| 2020/9/11 | NCT04561453 | Recruiting | 20 | Feasibility Study of Multi-Platform Profiling of Resected Biliary Tract Cancer | This study will test the ability to successfully obtain results from certain personalized tests for patients with biliary tract cancers that can be surgically removed. |
1. Biliary tract cancer 2. Cholangiocarcinoma 3. Gallbladder cancer 4. Intrahepatic cholangiocarcinoma 5. Perihilar cholangiocarcinoma 6. Extrahepatic cholangiocarcinoma 7.Hilar cholangiocarcinoma 8. Distal bile duct cancer |
1. Success rate of organoid culture and drug screening. The investigators will measure the percentage of patients for whom organoids can be successfully cultured and subjected to a drug screen. [Time Frame: Within 12 weeks after surgery] 2. Success rate of obtaining circulating tumor DNA (ctDNA) quantification and the ability to assess the change in ctDNA levels across those time points. The investigators will measure the percentage of patients for whom ctDNA was collected and quantified at multiple key time points across the course of a patient’s treatment. [Time Frame: Through study completion, an average of 4 years.] |
| 2016/3/5 | NCT02718235 | Unknown Status | 200 | Prospective, Multicenter HCCIS Evaluation Study | Building a database with HCC tumor organoids and testing the effect of CD8 + IL-33 + effector-memory cells on HCC tumor organoids of the respective HCCIS risk groups. | 1. Hepatocellular carcinoma |
1. The HCC immune score (HCCIS) is a survival predictor for patients after HCC resection. Overall survival |
| 2015/4/30 | NCT02436564 | Unknown Status | 75 | In Vitro Models of Liver and Pancreatic Cancer | The primary objective is to develop an in vitro model of cancer for laboratory study using liver, biliary, and pancreatic cancer tissues. The secondary objective is to study the genetic and cellular biology of cancer of the liver, biliary tract, and pancreas. |
1. Cholangiocarcinoma 2. Hepatocellular carcinoma 3. Pancreatic neoplasm |
1. Number of tumor-derived organoids successfully cultured in vitro for a minimum of 3 months. [Time Frame: 3 years] |
CRC, colorectal cancer; CTC, circulating tumor cell; ctDNA, circulating tumor DNA; GC, gemcitabine and cisplatin; HAI, hepatic artery infusion; HCC, hepatocellular carcinoma; HCCIS, the HCC immune score; ICC, intrahepatic cholangiocarcinoma; ORR, objective response rate; PDO, patient-derived tumor organoids; PDO-TIL, patient-derived organoids-tumor-infiltrating lymphocyte co-culture; PDOTS, patient-derived organotypic tissue spheroids; NGS, next generation sequencing