None listed
Conditions
Interventions
Drug : 1)Co administration group
- Gemcitabine : 1,000 ?/? IV at trial day 1, 8, 22, 29, 43, 50
- Cisplatin : 25 ?/? IV at trial day 1, 8, 22, 29, 43, 50
- Bojungikgi-tang : Twice a day during 63 days
Sponsors
Daegu Catholic University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosed as metastatic and progressing cholangiocarcinoma of non surgical resection cases, or the caese of incompletly resection worthy of on going checked by CT scans by gemcitabine with cisplatin therapy after 3, 6 or 9 periods of anticancer theparies. 2) Below ECOG performance(Eastern Cooperative Oncology Group) 2 3) Age above 20 and less than 80 4) No cognition deficit 5) Spontaneously agree to join, and sign to the consent form by him or herself of guardians 6) Can be observed during trial periods.
Exclusion criteria
Exclusion criteria: 1) Cholangiocarcinoma patients scheduled to be operated after anticancer therapies 2) Need to be surgically operated due to gastrointestinal obstruction 3) Hypertension not controlled by medicins 4) Above 3.4 mg% of serum creatinine 5) allergic or sensitive to Bojungikgi-tang 6) No agreement to the consent form 7) In pregnant or breast feeding state, or expecting a baby during the trial periods. 8) Taking another clinical trial medicines whithin one month 9) Except above cases, the cases of not going on judged by PI or the person in charge 10) No agreement to this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EORTC QLQ-C30,Pain rating scale,weight gain, analgesics,megesterol acetate,Anti-emetics | — |
Secondary
| Measure | Time frame |
|---|---|
| NCI CTCAE: Hematologic (CBC), GI toxicity(vomiting), renal toxicity (BUN/cr), LFT,RECIST and WHO Criteria(PD,SD,PR) | — |
Countries
Korea, Republic of
Contacts
Public ContactHo
Daegu Catholic University Medical Center
Outcome results
None listed