Clinical trial · Interventional
A Study to Investigate Apatinib Combined Capecitabine on Adjuvant Therapy of Biliary Carcinoma
Apatinib Combined Capecitabine Versus Capecitabine Alone for Adjuvant Therapy in Patients After Biliary Carcinoma Surgery: a Prospective Randomized Controlled Study
NCT03609489CI-TRIAL-00034258unknownPhase 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)
It is a prospective,parallel study to investigate the saftety and efficacy of Apatinib combined Capacitabine in the adjuvant treatment of the biliary cancinoma after operation.
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 |
|---|---|---|---|
| Biliary Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| Capecitabine | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Test Group
- description
- Apatinib combined with Capetabine
- interventionNames
- Drug: Capecitabine
- Drug: Apatinib
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Capecitabine
- interventionNames
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Fully aware of the research and voluntarily signed informed consent (informed consent must be signed prior to the execution of any required test procedure); * Patients received removal of biliary tract cancers that have been confirmed by histology or cytology, including intrahepatic bile duct carcinoma (IHCC), extrahepatic bile duct cancer (EHCC), and gallbladder cancer(GBC); * Normal function of major organs that meets the following criteria: Blood routine examination: HB≥90 g/L; ANC≥1.5×109/L; PLT≥60×109/L; Biochemical examination: ALB ≥29 g/L; ALT and AST\<2.5ULN; TBIL ≤2ULN; Creatinine≤1.5ULN; * ECOG physical condition scores 0 or 1; * Fertile male or female patients volunteer to use effective contraception methods during the research period, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. * Fertile and non-lactational female who show negative in serum or urine pregnancy test within 7 days before inclusion for the study. Exclusion Criteria: * Those who received approved or on-going anti-tumor therapy within 4 weeks before the research; * Those who received other anti-angiogenic tyrosine kinase inhibitors or monoclonal antibodies that had been approved or under study before the research; * Abnormal laboratory tests that have significant clinical implication; * International normalized ratio (INR) ≥ 1.5 or partially activated prothrombin time (APTT) ≥ 1.5 × ULN; * The patient's current serum potassium, serum magnesium, or serum calcium is below the normal reference range of laboratory test (whether supplemented or not), or \>CTCAE grade 1; * Patients currently suffering from hypertension that cannot be controlled with drugs; * The researchers conclude electrolyte abnormalities that are clinically significant; * There is severe bleeding or hemoptysis in the past or at current stage, or there are thromboembolic events within 12 months; * Cardiovascular diseases that are clinically significant; * ECG showed QTcB interval ≥ 480 milliseconds in resting state; * Suffering from other malignant tumors in the past 5 years, excluding basal cell carcinoma or squamous cell carcinoma after receiving radical surgery, or carcinoma in situ of cervix; * Active or uncontrollable serious infection (≥ CTCAE grade 2 infection), including but not limited to human immunodeficiency virus (HIV) infection; * Known history of liver disease with evident significance; * The patient currently has brain metastasis or spinal compression, except individual cases.
References
Publications (1)
- DERIVEDLuvira V, Satitkarnmanee E, Pugkhem A, Kietpeerakool C, Lumbiganon P, Pattanittum P. Postoperative adjuvant chemotherapy for resectable cholangiocarcinoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD012814. doi: 10.1002/14651858.CD012814.pub2. PMID 34515993