Multiple clinical trials evaluate therapeutic strategies and supportive management for gastrointestinal malignancies and rectal disorders, such as locally advanced rectal cancer, colon cancer, and low anterior resection syndrome. Ranging from Phase 1 to Phase 2 alongside protocols where phase classification is not applicable, trial statuses currently encompass recruiting, active not recruiting, and not yet recruiting. These studies are sponsored by academic institutions and clinical centers, including The First Hospital of Jilin University, Innovacion en Cirugía Vigo, and Korea University Anam Hospital.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05998122 | Not yet recruiting | Locally Advanced Rectal Cancer|Total Neoadjuvant Treatment|Anti-PD-1 |
The First Hospital of Jilin University |
2023-09-01 | Phase 2 |
| NCT05368168 | Recruiting | Rectal Disorders|Low Anterior Resection Syndrome|Low Anterior Resection |
Innovacion en Cirugía Vigo |
2022-06-03 | Not Applicable |
| NCT04906044 | Active not recruiting | Tislelizumab|Locally Advanced Rectal Cancer|Total Neoadjuvant Treatment|PD-1 |
The First Hospital of Jilin University |
2021-06-01 | Phase 1 |
| NCT05046756 | Recruiting | Colon Cancer |
Korea University Anam Hospital|National IT Industry Promotion Agency |
2021-05-11 | Not Applicable |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).