pharma · Acute Myeloid Leukemia · Breast Cancer
The First People's Hospital of Lianyungang
First People's Hospital is a pharma organization headquartered in SAN DIEGO, CA, CN. Primary therapeutic focus areas include Acute Myeloid Leukemia, Breast Cancer, Gastric Cancer, Multiple Myeloma, Esophageal Squamous Ce
Phase 2 · other · Cholangiocarcinoma
This program represents a Phase 2 radiotherapy study for cholangiocarcinoma sponsored by The First People's Hospital of Lianyungang. The program was terminated as of March 21, 2025. The clinical trial (NCT04866836) investigated radiotherapy as a treatment modality for cholangiocarcinoma, a rare biliary tract malignancy
Internal code Hepatobiliary Center
This program represents a Phase 2 radiotherapy study for cholangiocarcinoma sponsored by The First People's Hospital of Lianyungang. The program was terminated as of March 21, 2025. The clinical trial (NCT04866836) investigated radiotherapy as a treatment modality for cholangiocarcinoma, a rare biliary tract malignancy with limited therapeutic options. The sponsor's strategy focused on evaluating radiotherapy efficacy in this indication through controlled clinical investigation. The program has concluded without advancement to Phase 3, and no regulatory approvals or commercial milestones have been disclosed. The termination status indicates the sponsor has discontinued further development of this specific radiotherapy protocol for cholangiocarcinoma at this time.
Cholangiocarcinoma represents a significant unmet medical need, with limited curative treatment options and poor prognosis in advanced disease. The disease affects the bile ducts and carries high mortality rates, particularly when diagnosed at advanced stages. Radiotherapy represents a potential therapeutic approach for patients who may not be candidates for surgical resection or chemotherapy alone. The development of effective radiotherapy protocols could expand treatment options for cholangiocarcinoma patients and improve outcomes in a disease area with few approved therapies. However, the termination of this Phase 2 program suggests that the radiotherapy approach investigated did not meet efficacy or safety thresholds required for continued development. The competitive landscape for cholangiocarcinoma treatment remains limited, with few disease-specific approved therapies, making any successful radiotherapy protocol potentially significant. The termination of this trial indicates that alternative approaches or modifications to radiotherapy protocols may be necessary to advance treatment in this indication. Understanding why this program was terminated provides valuable intelligence for other sponsors considering radiotherapy development in cholangiocarcinoma.
This program evaluated radiotherapy as a treatment modality for cholangiocarcinoma. Radiotherapy represents a non-pharmacological intervention using ionizing radiation to target malignant cells. The specific radiotherapy protocol, dosing regimen, and technical parameters are not disclosed in available facts. The program was conducted at the Hepatobiliary Center of The First People's Hospital of Lianyungang, indicating a specialized institutional focus on biliary tract malignancies. No mechanism of action, molecular target, or specific radiotherapy technology (e.g., intensity-modulated radiotherapy, stereotactic body radiotherapy) has been disclosed. The modality is classified as 'other,' reflecting its non-small molecule, non-biologic nature. No patent status, manufacturing partner, or licensing arrangements have been disclosed.
Also known as: bile duct cancer, intrahepatic bile duct cancer (cholangiocarcinoma), CC, CCA, Cholangiocar.- intra/extrahepatic, Cholangiocellular carcinoma
Prevalence: Point prevalence: 1-9 / 100 000 (Worldwide) — source: Orphanet, validated.
A carcinoma that arises from the intrahepatic biliary tree (intrahepatic cholangiocarcinoma) or from the junction, or adjacent to the junction, of the right and left hepatic ducts (hilar cholangiocarcinoma). Grossly, the malignant lesions are solid, nodular, and grayish. Morphologically, the vast majority of cases are adenocarcinomas. Signs and symptoms include malaise, weight loss, right upper quadrant abdominal pain, and night sweats. Early detection is difficult and the prognosis is generally poor.
ClinicalTrials.gov lists 92 registered studies for Bile Duct Cancer (AACT aggregate).
Phase breakdown: NA (44), PHASE2 (21), PHASE1 (13), PHASE1/PHASE2 (4), PHASE4 (4), PHASE2/PHASE3 (3), PHASE3 (3)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0019087), Orphanet — cholangiocarcinoma, NCT00183846, NCT00280709, NCT00356161, NCT00579865, NCT00624182, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
Phase 2 trial initiated
NCT04866836 Phase 2 radiotherapy study for cholangiocarcinoma initiated at The First People's Hospital of Lianyungang.
Program terminated
Phase 2 radiotherapy program for cholangiocarcinoma terminated; no advancement to Phase 3 or regulatory filing disclosed.
The competitive landscape for cholangiocarcinoma treatment is limited. The facts provided list competitors primarily focused on antiinfective agents (tobramycin and related antibiotics) rather than cholangiocarcinoma-specific therapies, indicating a data mismatch or cross-indication analysis. Approved antiinfective competitors include TIGECYCLINE ACCORD (Amneal Pharma Europe Ltd, 70S ribosome inhibitor), QUINSAIR (Teva Pharma GmbH, DNA gyrase inhibitor), VIBATIV (Theravance Biopharma Ireland Limited), VABOREM (Amneal Pharma Europe Ltd, penicillin-binding protein inhibitor), COLOBREATHE (Essential Pharma Limited, cell membrane inhibitor), CUBICIN (MAIA Biotechnology, cell membrane inhibitor), SIVEXTRO, DORIBAX, ZINFORO, ARIKAYCE, CAYSTON, and ZAVICEFTA. These agents are not indicated for cholangiocarcinoma and represent a different therapeutic class. The termination of this radiotherapy program suggests that alternative approaches, including systemic chemotherapy, targeted therapies, or immunotherapy, may represent more promising development pathways for cholangiocarcinoma treatment.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| TIGECYCLINE ACCORD | Amneal Pharma Europe Ltd | Bacterial 70S ribosome inhibitor | approved |
| QUINSAIR | Teva Pharma GmbH | DNA gyrase inhibitor | approved |
| VIBATIV | Theravance Biopharma Ireland Umited | — | approved |
| VABOREM | Amneal Pharma Europe Ltd | Bacterial penicillin-binding protein inhibitor | approved |
| COLOBREATHE | Essential Pharma Limited | Cell membrane inhibitor | approved |
| CUBICIN | MAIA Biotechnology | Cell membrane inhibitor | approved |
| SIVEXTRO | — | Bacterial 70S ribosome inhibitor | approved |
| DORIBAX | — | Bacterial penicillin-binding protein inhibitor | approved |
| ZINFORO | — | Bacterial penicillin-binding protein inhibitor | approved |
| ARIKAYCE | — | Bacterial 70S ribosome inhibitor | approved |
| CAYSTON | — | Bacterial penicillin-binding protein inhibitor | approved |
| ZAVICEFTA | — | Bacterial penicillin-binding protein inhibitor | approved |
| PEMIGATINIB | — | Fibroblast growth factor receptor 2 inhibitor | Approved |
| INFIGRATINIB PHOSPHATE | — | Fibroblast growth factor receptor inhibitor | Approved |
| FUTIBATINIB | — | Fibroblast growth factor receptor inhibitor | Approved |
| TORIPALIMAB | — | Programmed cell death protein 1 antagonist | Phase 3 |
| TISLELIZUMAB | — | Programmed cell death protein 1 inhibitor | Phase 3 |
| TEGAFUR | — | Thymidylate synthase inhibitor | Phase 3 |
| PACLITAXEL | — | Tubulin inhibitor | Phase 3 |
| LENVATINIB MESYLATE | — | Vascular endothelial growth factor receptor inhibitor | Phase 3 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
Regulatory status for this radiotherapy program is not yet disclosed. The program was terminated on March 21, 2025, prior to any regulatory filing or approval. No FDA, EMA, PMDA (Japan), or NMPA (China) regulatory submissions or approvals have been reported. The trial was registered on ClinicalTrials.gov as NCT04866836 but no regulatory pathway designation (e.g., Breakthrough Therapy, Fast Track) has been disclosed. Regulatory intelligence regarding the reason for termination, safety or efficacy findings that prompted discontinuation, and any regulatory feedback from health authorities is not available in the disclosed facts.
This Phase 2 program evaluated radiotherapy for cholangiocarcinoma, a rare malignancy of the bile ducts, sponsored by The First People's Hospital of Lianyungang.
The program was terminated on March 21, 2025, and is no longer in active development.
Cholangiocarcinoma is a rare cancer arising from the epithelial cells of the bile ducts, with limited treatment options and poor prognosis in advanced disease.
The program was in Phase 2 clinical development when it was terminated.
The First People's Hospital of Lianyungang sponsored this program through its Hepatobiliary Center.
The program is registered as NCT04866836 on ClinicalTrials.gov.
The specific reasons for termination have not been disclosed; likely causes include insufficient efficacy, unacceptable safety profile, or failure to meet primary endpoints.
The specific radiotherapy modality, dosing regimen, and technical parameters have not been disclosed in available facts.
Results have not yet been reported; the program was terminated before results disclosure.
No regulatory approvals from FDA, EMA, PMPA, or NMPA have been disclosed for this specific radiotherapy protocol.
Treatment options include surgical resection, chemotherapy, targeted therapies, and radiotherapy; however, curative options are limited, particularly in advanced disease.
Specific competing radiotherapy programs for cholangiocarcinoma are not disclosed in the available facts.
Cholangiocarcinoma has limited curative treatment options, poor prognosis in advanced stages, and few approved disease-specific therapies, representing a significant unmet medical need.
No partner or licensing arrangement has been disclosed; the program appears to have been solely sponsored by The First People's Hospital of Lianyungang.
The First People's Hospital of Lianyungang is located in Lianyungang, China.
Future revival would require a new clinical program by this or another sponsor; the current program termination suggests the specific protocol investigated did not meet development criteria.
Radiotherapy → Drug → Target → Indication → Company → Trials → Competitors
Program Termination Implications: The termination of this Phase 2 radiotherapy program for cholangiocarcinoma on March 21, 2025, indicates that the investigational radiotherapy protocol did not meet predefined efficacy, safety, or futility thresholds required for Phase 3 advancement. Without disclosed results, the specific reasons for termination remain unclear but likely include insufficient efficacy, unacceptable toxicity, or failure to meet primary endpoints.
Competitive Implications: The termination reduces the near-term pipeline for cholangiocarcinoma radiotherapy approaches. Sponsors pursuing radiotherapy in this indication should carefully evaluate the factors that led to this program's discontinuation to inform protocol design and patient selection strategies.
Future Catalysts: Publication of Phase 2 results or retrospective analysis of why this program was terminated would provide valuable scientific intelligence. Alternative radiotherapy technologies, patient selection biomarkers, or combination approaches with systemic therapy may represent future development opportunities in cholangiocarcinoma.
Expected Milestones: No further clinical milestones are expected from this terminated program. Future development in cholangiocarcinoma radiotherapy would require initiation of a new protocol by this or another sponsor.
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Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.