Phase II Randomized Trial of SLOG vs GC in Locally Advanced or Metastatic Biliary Tract Cancer

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• Biliary Tract Neoplasms 482

Keywords

• SLOG

Study arms

• Experimental
  SLOG regimen

  Arm 1 interventions : SLOG regimen: treatment for every 14 days as one cycle Tegafur (S-1) 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day) Leucovorin 30 mg/b.i.d., day 1-7; Oxaliplatin 85 mg/m2 in 250 mL of 5% Glucose, given as 2-hour intra- venous infusion, day 1; Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate (FDR, 10 mg/m2/min) infusion, day 1; After the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin

  Drug: Tegafur · Drug: Leucovorin · Drug: Oxaliplatin · Drug: Gemcitabine

• Active comparator
  GC regimen

  Arm 2 interventions : GC regimen: treatment for every 21 days as one cycle Gemcitabine 1000 mg/m2 in 100 mL of normal saline, IV drip for 30 mins on D1 and D8 Cisplatin 25 mg/m2 in 250ml of normal saline, IV drip for 2 hours on D1 and D8

  Drug: Cisplatin

Interventions

• DrugTegafur

  Tegafur(S-1) 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day)

  Also known as: S-1

• DrugLeucovorin

  Leucovorin 30 mg/b.i.d., day 1-7

  Also known as: Folinic acid

• DrugOxaliplatin

  Oxaliplatin 85 mg/m2 in 250 mL of 5% Glucose, given as 2-hour intra- venous infusion, day 1

  Also known as: oxalic

• DrugGemcitabine

  Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate (, 10 mg/m2/min) infusion, day 1; After the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin. in SLOG arm. Gemcitabine 1000 mg/m2 in 100 mL of normal saline, IV drip for 30 mins on D1 and D8 ，in GC arm

  Also known as: Gemmis

• DrugCisplatin

  Cisplatin 25 mg/m2 in 250ml of normal saline, IV drip for 2 hours on D1 and D8

Primary outcomes

1. 6-month progression-free survival rate

   Tumor response will be evaluated by Response Evaluation Criteria in Solid Tumors (RECIST)Guidelines version 1.1.

   Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .

Secondary outcomes

1. tumor response

   Efficacy evaluations: objective tumor response according to RECIST 1.1

   Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .

2. Overall survival

   Overall survival: defined as the time from the date of first study treatment to the date of patient death, due to any cause, or to the last date the patient was known to be alive. The primary analysis population for the overall survival will be per-protocol population. The endpoint will also be analyzed in the intent-to-treat population. Kaplan-Meier estimates will be calculated for the overall survival.

   Time frame: Overall survival will be assessed. From date of registration until the date of death, assessed up to 60 months.

3. Disease control rate (Objective response rate (ORR) + stable disease ≧ 12 weeks)

   Efficacy evaluations: objective tumor response according to RECIST 1.1

   Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .

4. Safety profile

   Adverse events (AEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4 (CTCAE v4).All required pre-treatment and interim data should be available and the physician must have made a designation as to response if a re-evaluation has been performed and the grade of toxicity if any has occurred。

   Time frame: From date of registration to the date of disease progression or date of death from any cause, whichever came first, assessed up to 26 weeks .

5. Biomarker study

   evaluated for biomarkers, including inflammatory cytokine (TGF-β, hepatocyte growth factor (HGF), interleukin (IL)-6, IL-8, IL-1, CXCL-1, Chemokine (C-X-C motif) ligand 3(CXCL-3), and stromal-derived factor (SDF)...etc). Tumor DNA will be extracted from formalin-fixed paraffin-embedded(FFPE) slides for p53, CDKN2A and AT-rich interactive domain-containing protein 1A (ARID1A) mutation which were reported to be correlated with chemotherapy resistance

   Time frame: From date of registration to the date of disease progression or date of death from any cause or date of unacceptable toxicity or date of patient's refusal , whichever came first, assessed up to 26 weeks .

Individual participant data

Plan to share: No