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

NCT03406299 | Completed Phase 2 DMC

• 1 other identifier: T3217
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the following items in patients with locally advanced and metastatic biliary tract cancer receiving SLOG or GC treatment, Primary objective: 6-month progression-free survival rate Secondary objectives: Objective response rate Disease control rate (Objective response rate (ORR) + stable disease ≧ 12 weeks) Progression-free Survival Overall survival Safety profile Biomarker study

Conditions

Biliary Tract Neoplasms

Keywords

SLOG

Outcome Measures

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.

  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 (5)

• tumor response

  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 .

• Overall survival

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

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

  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 .

• Safety profile

  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 .

• Biomarker study

  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 .

Study Arms (2)

SLOG regimen

EXPERIMENTAL

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

GC regimen

ACTIVE COMPARATOR

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

Tegafur DRUG

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

Also known as: S-1

SLOG regimen

Leucovorin DRUG

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

Also known as: Folinic acid

SLOG regimen

Oxaliplatin DRUG

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

Also known as: oxalic

SLOG regimen

Gemcitabine DRUG

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

SLOG regimen

Cisplatin DRUG

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

GC regimen

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologically confirmed, advanced or metastatic biliary tract carcinoma (including intrahepatic bile duct, hilum bile duct, extrahepatic bile duct and gallbladder), except ampulla vater cancer or combined hepatocholangiocarcinoma.
• presence of at least one measurable tumor lesion which is defined as lesions that can be accurately measured in at least 1 dimension with longest diameter (LD) ≥20 mm using conventional techniques or ≥10 mm with spiral CT and MRI; measurable lymph nodes must be≥15 mm in the short axis.
• Patients must have no history of prior chemotherapy for Biliary Tract Cancer, except those delivered as adjuvant setting that completed at least 6 months before documentation of recurrence by imaging study.
• Patients with prior radiotherapy are eligible if the irradiated area does not involve the only source of measurable / evaluable disease.
• Patients' baseline Eastern Cooperative Oncology Group (ECOG)performance status must be less than or equal 1.
• Patients' life expectancy must be 12 weeks or greater.
• Patients' age must be more than or equal 20 years old.
• Patients must have adequate bone marrow function, defined as white blood cell (WBC) count ≥3,500/ul, absolute neutrophil count (ANC) 1,500/ul, and platelet count ≥100,000/ul.
• Patients must have adequate liver function and adequate renal function, defined as the following: serum alanine (ALT) 3 times upper normal limit, serum total bilirubin level less than or equal 2.0 mg/dL, and creatinine clearance rate (CCr) ≥ 60 mL/min ((based upon 24-hour urine collection or calculated by Cockcroft-Gault formula).
• Patients with biliary obstruction and adequate drainage procedures before enrollment are eligible.
• Patients must agree to have indwelling venous catheter implanted.
• Women or men of reproductive potential should agree to use an effective contraceptive method.
• All patients must be informed of the investigational nature of this study and must sign and give written informed consent.

You may not qualify if:

• Patients who have major abdominal surgery, radiotherapy or other investigating agents within 4 weeks are not eligible. Patients who have palliative radiotherapy for bony metastasis will be eligible 2 weeks after the completion of radiotherapy.
• Patients with central nervous system metastasis
• Patients with active infection
• Pregnant or breast-nursing women
• Patients with active cardiopulmonary disease or history of ischemic heart disease
• Patients who have peripheral neuropathy \> Grade I of any etiology, presence of grade 2 or above ascites or pleural effusion, or ≥ grade 2 of diarrhea.
• Patients who have serious concomitant systemic disorders incompatible with the study, i.e. poorly controlled diabetes mellitus, auto-immune disorders, cirrhosis of the liver, and the rest will be at the discretion of in-charged investigator.
• Patients who have other prior or concurrent malignancy except for adequately treated in situ carcinoma of cervix or adequately treated basal cell carcinoma of skin, or any malignancy remains disease-free for 3 or more years after initial curative treatment
• Patients who are under biologic treatment for their malignancy

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (1)

Taiwan Cooperative Oncology Group, National Health Research Institutes

Taipei, Taiwan

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Tegafur; S 1 (combination); Leucovorin; Oxaliplatin; Gemcitabine; Cisplatin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Fluorouracil; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Li-Tzong Cheng, PHD

  National Health Research Institute, Cancer Research

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2018
• First Posted: January 23, 2018
• Study Start: April 19, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)