Clinical trial · Interventional
A Study of Second-line Treatment With Apatinib for Advanced Intrahepatic Cholangiocarcinoma
Single Arm, Exploratory and Open Clinical Trial of Second-line Therapy With Apatinib Mesylate in Advanced Cholangiocarcinoma
NCT03521219CI-TRIAL-00032855unknownPhase 2ClinicalTrials.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)
The propose of this study is to confirm safety and efficacy of Apatinib monotherapy in patients with advanced cholangiocarcinoma.
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 |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Apatinib
- description
- Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
- interventionNames
- Drug: Apatinib
Primary outcomes (1)
- measure
- Disease Control Rate (DCR)
- timeFrame
- 1 month
- description
- the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease
Secondary outcomes (3)
- measure
- Progression-free Survival
- timeFrame
- 24 month
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Ages 18-65 years; 2. Eastern Cooperative Oncology Group performance score (ECOG): 0-2; 3. Estimated survival time \> 3 months; 4. Patients with recurrent or metastatic cholangiocarcinoma with histologic or cytological diagnosis; 5. Previous first-line GP programmes failed, or were not able to withstand first-line treatment; 6. At least one measurable lesion \[spiral CT scan ≥ 10 mm (CT scan thickness not greater than 5mm)\], Measurable lesions were not treated with radiotherapy or other topical treatments unless progress was achieved after treatment was completed (RECIST version 1.1); 7. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥ 1.5×109/L, PLT ≥ 75×109/L, HB ≥ 8 g/dL,ALB ≥2.8g/dL,TBIL ≤ 3×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Cr clearance ≥ 50 mL/min;Thyroid function is normal; 8. No serious history of drug allergy; 9. Subjects volunteered for the study. Sign informed consent, good compliance, with follow-up. Exclusion Criteria: 1. Patients have received targeted therapy; 2. 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); 3. Coagulation dysfunction (INR\> 1.5, PT\> ULN +4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment; 4. Urine routine showed that urine protein ≥++ or the urine protein in 24 hours\>1.0 g; 5. Pregnant or lactating women; 6. History of other malignancy within 5 years except for effectively treated skin basal cell carcinoma, cutaneous squamous cell carcinoma and / or effectively excised orthotopic cervical and / or breast cancer; 7. The researchers judged other conditions that might affect clinical research and the outcome of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.