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

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Treatments: Cisplatin; Gemcitabine; Leucovorin; Oxaliplatin; Tegafur

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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