Table 4 List of clinical trials investigating PDTOs for functional precision testing
From: Clinical translation of patient-derived tumour organoids- bottlenecks and strategies
Gastrointestinal System | |||||||||
|---|---|---|---|---|---|---|---|---|---|
Pancreatic Cancer | |||||||||
| Â | Identifiers | Status | Stage of Cancer | Histology | Method of Tissue Acquisition | Drugs | Life Expectancy | Inclusion Criteria | Exclusion Criteria |
1 | NCT04931394 | Recruiting | Early | - Pancreatic Carcinoma - Pancreatic Adenocarcinoma - Mucinous Adenocarcinoma - Adenosquamous Carcinoma | Surgical Resection | Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan |  > 90 days | Complete R0 resection for pancreatic cancer with no evidence of malignant ascites, peritoneal metastases or distant metastases | Cannot tolerate targeted chemotherapy and targeted therapy |
Severely Impaired Organ Function | |||||||||
2 | NCT04931381 | Recruiting | Locally advanced/ metastatic | - Pancreatic Carcinoma - Pancreatic Adenocarcinoma - Mucinous Adenocarcinoma - Adenosquamous Carcinoma | Core needle biopsy | Gemcitabine, 5-fluorouracil, Paclitaxel, Oxaliplatin, Irinotecan |  > 90 days | Patient must have a tumour lesion that is amenable to a core needle biopsy | Cannot tolerate targeted chemotherapy and targeted therapy |
Severely Impaired Organ Function | |||||||||
Breast Cancer | |||||||||
3 | NCT04450706 | Recruiting | Metastatic | HER2-negative Breast Cancer | Tumour Biopsy | Docetaxel, Cyclophosphamide, Adriamycin, Methotrexate, 5-fluorouracil, Paclitaxel |  > 6 months | Metastatic or recurrent unresectable breast cancer: | Unable to undergo biopsy safely |
Triple-negative breast cancer without prior treatment in the metastatic setting | Severely Impaired Organ Function | ||||||||
Willing and able to undergo a baseline biopsy. Safely undergo tumour biopsy | Diagnosis of any other malignancy within 2Â years | ||||||||
Successful acquisition of a tissue sample containing ≥ 20% tumor content | |||||||||
4 | NCT03544047 | Unknown | 2–3 | Breast Cancer | Surgical Resection, Tumour Biopsy | Paclitaxel, Trastuzumab |  > 6 months | No prior treatment | Unable to obtain sufficient tumor organizer by operation or biopsy |
According to the RECIST standard, the lesion was measured (the diameter of the primary lesion was greater than 1.0Â cm or the short diameter of the lymph node was greater than 1.5Â cm) | History of other malignancies | ||||||||
Metastatic lesions or primary lesions can obtain surgical tissue or adequate biopsy tissue | Severely Impaired Organ Function | ||||||||
5 | NCT05177432 | Not yet recruiting | All | Breast Cancer of any subtype | Tumour Biopsy | 10–12 anti-cancer drugs (Alpelisib, transtuzumab-emtansine and others not specified) |  > 12 weeks | • At least 1 tumour lesion (primary or metastatic) amenable to fresh biopsy • At least 1 measurable tumour lesions based on RECIST 1.1 criteria • Has documented progressive disease from last line of therapy • Has received at least 1 line of palliative systemic therapy | • Male Breast Cancer • Pregnancy • Secondary Primary Malignancy • Contraindication to anti-cancer therapy in drug screening panel • Treatment within last 30 days with any other drug Concurrent administration of other tumour therapies |
| Â | Respiratory System | ||||||||
| Â | Lung Cancer | ||||||||
6 | NCT05136014 | Enrolling by Invitation | All | Lung Cancer Lung Adenocarcinoma EGFR Activating Mutation KRAS Mutation-Related Tumors Non Small Cell Lung Cancer | Surgical Resection | Osimertinib |  > 30 days | With non small cell lung cancer of any stage undergoing surgical resection at the Nancy University Hospital | • Hepatitis • HIV •Pregnancy |
| Â | Urinary System | ||||||||
| Â | Bladder Cancer | ||||||||
7 | NCT05024734 | Not yet recruiting | Early (non muscle invasive) | intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) | Tumour Biopsy | Epirubicin Mitomycin Gemcitabine Docetaxel |  > 24 months | • Histologically confirmed intermediate risk non muscle-invasive urothelial carcinoma of the bladder (pTa low grade) Patients Representative fresh tumor specimen for PDO generation and drug screen | • Known previous high grade and/or high risk non muscle-invasive bladder cancer • Previous Intravesical biological/immuno (BCG) therapy • Severe infection within 4 weeks prior to cycle 1, day 1 • Contraindication for frequent catheterization Voiding dysfunction |
| Â | Different Cancers | ||||||||
| Â | Head and Neck, Colorectal, Breast, Ovarian Cancer | ||||||||
8 | NCT04279509 | Recruiting | All | Histological or cytological diagnosis of head and neck squamous cell carcinoma (HNSCC), colorectal, breast or epithelial ovarian cancer | Tumour Core Biopsy, Blood Sampling | 5-fluorouracil, carboplatin, cyclophosphamide, docetaxel, doxorubicin, gemcitabine, irinotecan, oxaliplatin, paclitaxel and vinorelbine. etoposide, ifosfamide, methotrexate, pemetrexed and topotecan |  > 12 weeks | At least 1 tumour lesion (primary or metastatic) amenable to fresh biopsy | Pace of cancer progression requiring commencement of anti-cancer therapy within 4 to 6 weeks |
At least 1 measurable tumour lesions based on RECIST 1.1 criteria | Severely Impaired Organ Function | ||||||||
Able to wait at least 4 to 6Â weeks before initiating the next line of anti-cancer therapy | Â | ||||||||
Has received at least 2 lines of palliative systemic therapy | Â | ||||||||