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Clinical study for apatinib mesylate treated with gemcitabine combined with platinum for treatment failure of bile duct tumor

Clinical study for apatinib mesylate treated with gemcitabine combined with platinum for treatment failure of bile duct tumor

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018332
Enrollment
Unknown
Registered
2018-08-02
Start date
2018-08-09
Completion date
Unknown
Last updated
2018-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Biliary tract tumor

Interventions

Case series:apatinib

Sponsors

Shanghai Dongfang Department of Hepatobiliary Surgery Hospital precision Medicine Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. pathology or cytology is diagnosed as intrahepatic cholangiocarcinoma or extrahepatic cholangiocarcinoma; 2. according to the RECIST standard (see Appendix 1), measurable assessment can be made; 3. aged from 18 to 75 years; 4. WHO/ECOG physical strength score (see Appendix 2) reached 0-2; 5. there were at least 2 cycles of GP chemotherapy before; 6. enough bone marrow hematopoietic reserve (white blood cell count > 3 x 10^9/L, platelet count > 90 x10^9/L); 7. adequate liver bilirubin (equal to or less than 1.5 times the upper limit of normal (ULN); 8. adequate renal reserve (creatinine clearance > 60 ml/min; creatinine <120 mu mol/L); 9. no heart failure and uncontrolled chest pain. No myocardial infarction occurred within 12 months before the start of the study; 10. the letter of informed consent was signed.

Exclusion criteria

Exclusion criteria: 1. in the 3 years before the start of the study, there were two malignant tumors or other tumors accompanied by metastasis of brain or meninges; 2. there are contraindications related to the use of apatinib, such as severe hypertension, high bleeding risk, and severe nephrotic syndrome; 3. with chronic diarrhea or colitis or inflammatory conditions, effects of systemic administration of untreated good occlusion or sub block; 4. infection activity or other serious infections that may hinder patients from receiving planned treatment. For example, long term uncontrolled destruction of biliary tract bacterial cholangitis; 5. cardiac insufficiency, unstable angina pectoris, congestive heart failure, acute myocardial infarction and serious uncontrollable arrhythmia within the first 6 months of the group.

Design outcomes

Primary

MeasureTime frame
Progression Free survival;

Secondary

MeasureTime frame
Overall survival;Remission rate;Quality of life;Adverse event;

Countries

China

Contacts

Public ContactZhengang Yuan

Shanghai Orient Department of Hepatobiliary Surgery Hospital

489623019@QQ.COM+86 13764973787

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026