Table 3.
Clinical application of patient-derived cancer organoids from clinicaltrials.gov
| NCT Number | Status | Cancer Type | Stage of Cancer | Phase | Application | Outcome Measurement | Sample Size | Start date |
|---|---|---|---|---|---|---|---|---|
| NCT06196554 | Recruiting | Gastric Cancer | All stage | NA | Drug screening | Sensitivity, Specificity, Consistency | 40 | 2023-05-01 |
| NCT06100003 | Recruiting | Gastric Cancer | All stage | Phase 1 | Drug testing | DFS, Sensitivity, Specificity | 104 | 2023-10-18 |
| NCT05442138 | Unknown | Gastric Cancer | Early | NA | Drug testing | ORR, TRG | 54 | 2022-06-28 |
| NCT05351398 | Unknown | Gastric Cancer | Advanced | NA | Treatment comparison | ORR, TRG, RR | 54 | 2022-04-28 |
| NCT05203549 | Unknown | Gastric Cancer | All stage | NA | Treatment consistency observations | PDCOs success rate, Correlation | 250 | 2021-05-01 |
| NCT06907342 | Recruiting | Colorectal Cancer | Metastasis | Phase 2 | Drug testing | PDCOs success rate, ORR, DCR, PFS, OS, DOR | 148 | 2025-05-23 |
| NCT06787625 | Recruiting | Colorectal Cancer |
Primary/ Metastasis |
NA | PDCOs Establishment | PDCOs success rate | 10 | 2024-05-25 |
| NCT06136949 | Recruiting | Colorectal Cancer | All stage | NA | Drug testing | PFS, Correlation | 150 | 2023-05-22 |
| NCT06100016 | Recruiting | Colorectal Cancer | All stage | Phase 1 | Drug testing | PFS, Sensitivity, Specificity | 105 | 2023-10-18 |
| NCT05955196 | Recruiting | Colorectal Cancer | All stage | NA | Drug testing | PDCOs success rate | 115 | 2023-01-09 |
| NCT05883683 | Not yet recruiting | Colorectal Cancer |
Advanced/ Recurrent |
NA |
Drug testing/ Target prediction |
Viability of PDCOs, Correlation, Sensitivity |
100 | 2024-10-01 |
| NCT05832398 | Recruiting | Colorectal Cancer | All stage | NA | Drug testing | Correlation, PFS, OS | 186 | 2023-05-01 |
| NCT05725200 | Recruiting | Colorectal Cancer | Metastasis | Phase 2 | Treatment consistency observations |
ORR, PFS, DOR, OS, Safety and tolerability |
40 | 2022-09-27 |
| NCT05401318 | Recruiting | Colorectal Cancer | All stage | NA | Drug testing | PDCOs success rate, Sensitivity | 40 | 2022-03-28 |
| NCT05352165 | Not yet recruiting | Rectal Cancer | Advanced | NA | Treatment comparison | PCR, Complication, Recurrence, Metastasis | 192 | 2023-01-01 |
| NCT05304741 | Recruiting | Colorectal Cancer |
Advanced/ Recurrent/ Metastasis |
NA |
PDCOs Establishment/ Drug screening |
PFS, OS, Sensitivity, Specificity | 30 | 2020-01-01 |
| NCT05183425 | Unknown | Colorectal Cancer | Metastasis | NA | Drug testing | Correlation, PDCOs success rate | 60 | 2022-01-01 |
| NCT05038358 | Recruiting | Colorectal Cancer | Primary | NA | Drug Resistance | PDCOs success rate | 60 | 2022-12-12 |
| NCT04996355 | Unknown | Colorectal Cancer | All stage | NA | Drug screening | Accuracy, Specificity, Sensitivity | 52 | 2021-05-31 |
| NCT04906733 | Unknown | Colon Cancer | All stage | NA | Treatment consistency observations | Sensitivity, Correlation | 80 | 2021-04-15 |
| NCT04755907 | Unknown | Colorectal Cancer | All stage | NA | Model comparison |
PDCOs sensitivity, Correlation, DFS |
120 | 2021-03-01 |
| NCT04371198 | Completed | Rectal Cancer | All stage | NA | PDCOs Establishment | PDCOs success rate | 20 | 2020-09-18 |
| NCT03577808 | Unknown | Rectal Cancer | All stage | NA | Drug/Irradiation testing | Correlation, PDCOs success rate | 80 | 2018-08-17 |
| NCT07054086 | Recruiting | Esophageal Cancer | All stage | NA | Drug testing | PDCOs success rate, Correlation | 30 | 2025-03-01 |
| NCT03283527 | Recruiting | Esophageal Cancer | All stage | NA | Drug/Irradiation testing |
PDCOs success rate, Sensitivity, PFS, OS |
100 | 2017-12-01 |
| NCT06929845 | Recruiting | Liver Cancer | All stage | NA | PDCOs Establishment | PDCOs success rate, Correlation | 150 | 2024-10-01 |
| NCT06699524 | Active | Liver Cancer | All stage | NA | Drug testing | PFS | 122 | 2022-09-20 |
| NCT06355700 | Recruiting | Liver Cancer | All stage | NA | PDCOs Establishment | co-culture PDCOs success rate, Correlation | 10 | 2023-06-15 |
| NCT05932836 | Active | Liver Cancer | All stage | NA | Drug testing | PDCOs success rate, Accuracy | 165 | 2023-03-01 |
| NCT05913141 | Recruiting | Liver Cancer | All stage | NA | Drug testing | PDCOs/co-culture PDCOs success rate, ORR, PFS, RFS… | 30 | 2023-06-22 |
| NCT05644743 | Not yet recruiting |
Intrahepatic Cholangiocarcinoma |
All stage | NA | Treatment consistency observations |
Correlation, Drug resistance model |
40 | 2022-12-09 |
| NCT05634694 | Unknown | Cholangiocarcinoma | All stage | NA | Treatment consistency observations | PFS, Sensitivity | 40 | 2022-11-30 |
| NCT04561453 | Completed | Cholangiocarcinoma | All stage | NA | Drug testing | PDCOs success rate, Correlation | 14 | 2020-07-08 |
| NCT04072445 | Completed | Cholangiocarcinoma | Advanced | Phase 2 | Drug resistance | Correlation, Clinical Benefit | 28 | 2019-10-18 |
| NCT06813079 | Not yet recruiting | Pancreatic Ductal Carcinoma | Advanced | Phase 2 | Drug testing |
ORR, DCR, DOR, PFS, OS, Side effects |
25 | 2025-02-17 |
| NCT06666803 | Not yet recruiting | Pancreatic Ductal Adenocarcinoma | All stage | NA | PDCOs Establishment | PDCOs success rate, Correlation | 60 | 2024-10-31 |
| NCT06615830 | Not yet recruiting | Pancreatic Cancer | Metastasis | Phase 2 | Drug testing | PDCOs sensitivity, PFS, Correlation | 185 | 2024-09-27 |
| NCT05927298 | Recruiting | Pancreatic Cancer | All stage | NA | PDCOs Establishment | PDCOs success rate, Correlation, AI platform establishment | 200 | 2023-03-06 |
| NCT05351983 | Unknown | Pancreatic Cancer | All stage | NA | Drug screening | PDCOs success rate, Safety, Contamination rates | 50 | 2022-09-22 |
| NCT05196334 | Recruiting | Pancreatic Cancer | All stage | NA | Drug testing | PDCOs response to therapy | 88 | 2021-07-01 |
| NCT04931394 | Unknown | Pancreatic Cancer | All stage | Phase 3 | Drug testing |
DFT, OS, DFS PDCOs success rate, Correlation |
200 | 2021-06-01 |
| NCT04931381 | Unknown | Pancreatic Cancer | Advanced | Phase 3 | Drug testing |
DCR, PFS, OS, PDCOs success rate, Correlation |
100 | 2021-06-01 |
| NCT04777604 | Not yet recruiting | Pancreatic Cancer | All stage | NA |
Drug testing/ Prognosis |
OS | 300 | 2021-03-01 |
| NCT04736043 | Recruiting | Pancreatic Cancer | All stage | NA |
Drug testing/ Prognosis |
OS | 300 | 2021-01-31 |
| NCT04469556 | Active | Pancreatic Cancer |
Advanced/ Metastasis |
Phase 2 | Treatment comparison | PFS, ORR, OS, Correlation | 150 | 2020-10-14 |
| NCT03990675 | Unknown | Pancreatic Cancer | All stage | NA | PDCOs Establishment | PDCOs success rate | 50 | 2018-12-01 |
| NCT03544255 | Unknown | Pancreatic Cancer | All stage | NA | Drug screening | PDCOs success rate, Correlation | 50 | 2018-05-01 |
| NCT03500068 | Unknown | Pancreatic Cancer | Metastasis | NA | PDCOs Establishment | PDCOs success rate, Biomarkers | 30 | 2017-09-04 |
| NCT03140592 | Unknown | Pancreatic Cancer | All stage | NA | PDCOs Establishment | PDCOs success rate | 300 | 2015-01-14 |
| NCT06519500 | Recruiting | Gastroenteropancreatic Neuroendocrine Tumor | All stage | NA | PDCOs Establishment | PDCOs success rate | 40 | 2023-03-03 |
| NCT06246630 | Recruiting | Pancreatic Neuroendocrine Tumor | Advanced | NA | Drug testing | PDCOs success rate, ORR, PFS, OS, Correlation | 20 | 2024-04-03 |
| NCT04927611 | Unknown | Gastroenteropancreatic Neuroendocrine Tumor | All stage | NA | PDCOs Establishment | PDCOs success rate, TME | 200 | 2021-06-06 |
| NCT06332716 | Recruiting | Gastrointestinal Tumors | All stage | Phase 3 | Drug testing | PFS, OS | 68 | 2022-08-26 |
| NCT06077591 | Recruiting |
Liver Cancer/ Colorectal Cancer |
Advanced/Inoperable | Phase 3 | Drug testing | Tumor response, ORR, PFS, OS, PDCOs success rate | 40 | 2024-10-18 |
| NCT05842187 | Unknown |
Pancreatic Cancer/ Gastric Cancer |
Metastasis | NA | Treatment consistency observations | PFS, DCR | 20 | 2023-03-03 |
| NCT05652348 | Recruiting |
Gastric Cancer/ Colorectal Cancer |
All stage | NA | Drug testing |
Sensitivity, DNA/RNA sequence |
48 | 2022-12-08 |
| NCT05384184 | Completed |
Liver Cancer/ Colorectal Cancer |
Metastasis | NA | PDCOs Establishment | PDCOs success rate, Correlation | 48 | 2019-06-06 |
| NCT04611035 | Unknown | Gastrointestinal Cancers | All stage | NA | Drug screening | PDCOs success rate, ORR | 100 | 2020-01-20 |
| NCT03429816 | Completed |
Gastric Cancer/ Esophageal Cancer |
All stage | NA | Drug testing | Correlation, Histological regression, PFS, OS | 120 | 2018-04-15 |
| NCT02436564 | Unknown |
Cholangiocarcinoma/ Liver Cancer/ Pancreatic Cancer |
All stage | NA | PDCOs Establishment | PDCOs success rate | 75 | 2015-05-07 |
Note: Search strategy: A combined search was performed on the ClinicalTrials.gov platform by selecting the disease: Digestive cancer/tumor; and the term: organoids. “Digestive cancer” can be replaced with liver cancer, cholangiocarcinoma, gastric cancer, colorectal cancer, intestinal cancer, esophageal cancer, and pancreatic cancer for comprehensive retrieval. After inclusion and exclusion based on relevance to this article, 60 clinical trials were included for analysis
PDCOs: Patient-derived cancer organoids. DFS: Disease-free survival. ORR: Objective response rate. TRG: Tumor regression grading. RR: Recurrence rate. DCR: Disease control rate. OS: Overall survival. DOR: Duration of Response. PFS: Progression-free survival. RFS: Recurrence-free survival. DFT: Disease free time. PCR: Pathologic complete response. TME: Tumor microenvironment