Clinical trial · Interventional
Bortezomib in Intrahepatic Cholangiocellular Carcinoma
Bortezomib in Treating Patients With Intrahepatic Cholangiocellular Carcinoma Featuring PTEN Deficiency
NCT03345303CI-TRIAL-00030388unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the efficacy and safety of second-line treatment of bortezomib in advanced intrahepatic cholangiocarcinoma patients.Half of participants will receive bortezomib while the other half will receive best supporting care.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intrahepatic Cholangiocarcinoma | Intrahepatic Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Bortezomib treatment
- description
- 'Bortezomib Injectable Solution
- interventionNames
- Drug: Bortezomib
- type
- NO_INTERVENTION
- label
- supportive care
- description
- supportive care
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- at least 2 months
- description
- Objective response rate include response from stable disease to complete response based on RECIST 1.1
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a histologic or cytologic diagnosis of intrahepatic cholangiocarcinoma with stage IV; 2. Have progressed after at least 2 cycles of systematic chemotherapy therapy(gemcitabine+cisplatin/gemcitabine+oxaliplatin); 3. The previous treatment and the present trial registration must be at least 2 weeks apart, and they must have recovered from any toxicity of a previous treatment; 4. Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1; 5. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; Life expectancy of at least 12 weeks; 6. Normal liver,kidney and bone marrow function; 7. Subjects who understand and voluntarily signed a written informed consent form. Exclusion Criteria: 1. History of other malignancy within 3 years. Patients with central nervous system metastases or brain metastasis 2. There is any contraindication to use Bortezomib 3. Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, within 30 days after major surgery, uncontrolled high blood pressure medication, III-IV level cardiac insufficiency, severe liver and kidney dysfunction). 4. A previous history of Interstitial pulmonary disease, drug-induced interstitial disease, radiation pneumonitis requiring hormonal therapy or active interstitial lung disease with any clinical evidence. 5. Pregnant or lactating women. 6. History of radiation within 4 weeks prior to enrollment.
References
Publications (1)
- DERIVEDZeng TM, Jiang TY, Yang G, Cheng Z, Lou C, Wei W, Tao CJ, Hu S, Wang H, Cui XW, Tan YX, Dong LW, Wang HY, Yuan ZG. Bortezomib in previously treated phosphatase and tension homology-deficient patients with advanced intrahepatic cholangiocarcinoma: An open-label, prospective and single-centre phase II trial. Clin Transl Med. 2024 May;14(5):e1675. doi: 10.1002/ctm2.1675. PMID 38689424