UnknownPhase 2

Study of S-1 Oxaliplatin (SOX) for Biliary Tract Cancer (BTC) (Ampullary Adenocarcinoma)

China40 participantsStarted 2010-08

Plain-language summary

To evaluate efficacy and safety of S-1 Oxaliplatin (SOX) regimen to patients with unresectable, metastatic or locally advanced biliary tract or ampullary adenocarcinoma.

Who can participate

Age range18 Years – 74 Years

SexALL

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Inclusion criteria

✓. Informed consent has been signed by the subject itself;
✓. Aged over 18;
✓. With a definite pathological or cytological diagnosis of adenocarcinoma;
✓. No pre-treatment (including radiotherapy, chemotherapy, immunotherapy, etc.). For recurrent cases, if the subjects have received adjuvant chemotherapy without S-1 or L-OHP after surgery and the time to the end date of adjuvant chemotherapy is over 6 months, they can also be enrolled;
✓. Enhanced helical CT or MRI scanning shows a target lesion over 1cm within 14 days before enrollment
✓. Within 7 days before enrollment, baseline blood routine and biochemical indicators meet the following criteria:
✓. Can receive oral administration;
✓. Karnofsky(KPS) score ≥ 70 points;

Exclusion criteria

✕. Patients with a severe drug allergy history (including mildly allergic to L-OHP, 5-FU, FT207, 5-HT3 receptor antagonist);
✕. Patients who participated or are participating in other clinical trials within 4 weeks before enrollment;
✕. Patients who have received blood transfusion, blood products and hematopoietic factor preparations such as G-CSF within 15 days before enrollment;
✕. Patients who have undergone a surgery within 15 days before enrollment, and its effects have not been eliminated;
✕. Patients with diarrhea;
✕. Patients with a complication of active infection (infection causes a fever above 38 ℃);
✕. Patients accompanied by dysphagia, complete or incomplete gastrointestinal obstruction, active gastrointestinal bleeding and perforation, etc. that cause difficulty in taking S-1 orally;
✕. Patients with severe liver disease (e.g. active hepatitis, cirrhosis, etc.), renal insufficiency, severe lung disease (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.), or uncontrollable diabetes, hypertension and other chronic systemic diseases;

What they're measuring

objective response rate

Timeframe: 2 years

Trial details

NCT IDNCT01180153

SponsorPeking University Cancer Hospital & Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-08

Contact for this trial

Jie Li, Doctor

010-88121122 xiaotong10241@sina.com

View on ClinicalTrials.gov More Biliary Tract Cancer trials