Numerous clinical trials evaluate the therapeutic potential of lobaplatin across Phase 1 through Phase 4 studies, focusing on solid tumors including recurrent ovarian cancer, triple-negative breast cancer, small cell lung carcinoma, esophageal carcinoma, and advanced osteosarcoma. Primarily sponsored by academic medical centers, university hospitals, and research associations, these trials frequently evaluate combination chemotherapeutic regimens. The overall portfolio encompasses various recruitment statuses, including actively recruiting, completed, enrolling by invitation, and unknown.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07093931 | NOT_YET_RECRUITING | Breast Cancer |
Shandong Cancer Hospital and Institute |
2025-08-01 | PHASE4 |
| NCT06688175 | ENROLLING_BY_INVITATION | Nasopharyngeal Neoplasms; Elderly; Chemotherapy |
The First Affiliated Hospital of Xiamen University |
2024-11-13 | PHASE2 |
| NCT05766605 | UNKNOWN | Hepatocellular Carcinoma Resectable |
Zhujiang Hospital |
2023-01-01 | PHASE3 |
| NCT05701436 | UNKNOWN | Liver, Cancer of, Primary Resectable |
Zhujiang Hospital |
2022-09-01 | PHASE3 |
| NCT05780294 | NOT_YET_RECRUITING | Nasopharyngeal Carcinoma; Leucogen; Chemotherapy; Myelosuppression |
Sun Yat-sen University |
2023-04-01 | PHASE3 |
| NCT06169410 | UNKNOWN | Advanced Gastric Cancer |
Yang Jianjun, PhD |
2023-12-30 | PHASE4 |
| NCT06714383 | RECRUITING | Osteosarcoma |
Peking University People's Hospital |
2024-11-13 | PHASE2 |
| NCT06586242 | RECRUITING | Esophageal Cancer |
Xijing Hospital |
2023-04-03 | PHASE2 |
| NCT06198465 | UNKNOWN | Adebrelimab; Esophageal Cancer; Perioperative Period |
Xijing Hospital |
2024-03-30 | PHASE2 |
| NCT06170697 | UNKNOWN | Head and Neck Squamous Cell Carcinoma |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
2023-03-01 | PHASE2 |
| NCT04845490 | UNKNOWN | Colorectal Cancer; Chemotherapy Effect; Surgery; Metastasis; Survival |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2022-09-01 | PHASE2 |
| NCT03371693 | UNKNOWN | Ovarian Cancer; Ovary Neoplasm; Ovarian Neoplasms; Epithelial Ovarian Cancer; Ovarian Cancer, Epithelial; Hyperthermic Intraperitoneal Chemotherapy(HIPEC) |
Zhongnan Hospital |
2017-09-30 | PHASE3 |
| NCT05546255 | UNKNOWN | Triple Negative Breast Cancer |
Chinese Academy of Medical Sciences |
2020-06-01 | PHASE2 |
| NCT04808466 | UNKNOWN | Gastric Cancer; Chemotherapy Effect; Surgery; Metastasis; Survival |
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
2021-09-18 | PHASE2 |
| NCT03221608 | UNKNOWN | Colorectal Neoplasms |
Sixth Affiliated Hospital, Sun Yat-sen University |
2017-08-01 | PHASE3 |
| NCT03613597 | UNKNOWN | Small-cell Lung Cancer |
Guizhou Medical University |
2018-06-01 | PHASE2 |
| NCT03700359 | UNKNOWN | Small Cell Lung Carcinoma |
The First Affiliated Hospital of Guangzhou Medical University |
2019-03-01 | PHASE2 |
| NCT03613753 | UNKNOWN | Small-cell Lung Cancer |
ShengFa Su |
2018-06-01 | PHASE2 |
| NCT03210389 | UNKNOWN | Recurrent Nasopharyngeal Carcinoma |
Sun Yat-sen University |
2017-07 | PHASE2 |
| NCT03117257 | UNKNOWN | Locally Advanced Head and Neck Squamous Cell Carcinoma |
Guiyang Medical University |
2016-08-19 | PHASE2 |
| NCT02301091 | UNKNOWN | Hepatocellular Carcinoma |
Ming Zhao |
2014-10 | PHASE3 |
| NCT03413436 | COMPLETED | Esophageal Cancer |
Henan Cancer Hospital |
2018-01-31 | PHASE4 |
| NCT03188497 | COMPLETED | Acute Toxic Effects; Tumor Responses |
Fifth Affiliated Hospital, Sun Yat-Sen University |
2016-06-22 | PHASE1 |
| NCT02972320 | UNKNOWN | Extensive Stage Small Cell Lung Cancer |
Yunpeng Liu |
2016-06 | PHASE2 |
| NCT02099396 | UNKNOWN | Lobaplatin and Gemcitabine in Combination, Second-line Treatments on Advanced Osteosarcoma |
China Association of Osteosarcoma Chemotherapy |
2014-04 | PHASE2; PHASE3 |
| NCT01483300 | UNKNOWN | Breast Cancer |
Harbin Medical University |
2011-11 | PHASE2 |
| NCT01851746 | Unknown status | Recurrent Ovarian Cancer |
Wuhan University |
2013-03 | -- |
| NCT01034683 | UNKNOWN | Esophageal Carcinoma |
Taian Cancer Hospital |
2009-12 | PHASE3 |
(data from https://clinicaltrials.gov, updated on 2025-07-30)
Check the
Lobaplatin (D-19466)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
Note: Technical data last updated: Sep 1, 2026.