SIRT Followed by CIS-GEM Chemotherapy Versus CIS-GEM Chemotherapy Alone as 1st Line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

• Status: Active, not recruiting
• Trial end date: 2021-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the benefit of applying Selective Internal Radiation Therapy (SIRT) using SIR-Spheres Y-90 resin microspheres prior to receiving systemic chemotherapy treatment (cisplatin-gemcitabine, or CIS-GEM) in patients with unresectable intrahepatic cholangiocarcinoma. Half of the patients will be randomized to CIS-GEM chemotherapy plus SIRT, and half of the patients will be randomized to CIS-GEM alone.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sirtex Medical
• Treatments: Cisplatin; Gemcitabine

Criteria

Inclusion Criteria:

• Willing, able and mentally competent to provide written informed consent.

• Aged 18 years or older.

• Histologically or cytologically confirmed unresectable and non-ablatable intrahepatic cholangiocarcinoma.

• Liver-only or liver predominant intrahepatic cholangiocarcinoma. Patient are permitted to have loco-regional lymph node involvement defined as: portal LNpara aortic LNlesions < 1 cm if these lung lesions are positron emission tomography (PET) negative.

• Chemotherapy naïve. Adjuvant chemotherapy is not permitted.

• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

• Adequate hematological function defined as:

Hemoglobin >/= 10g/dL White Blood Cell count (WBC) >/= 3.0 x 10^9/L Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L Platelet count >/= 100,000/mm^3 - Adequate liver function defined as: Total bilirubin/= 30 g/L

• Adequate renal function defined as: Serum urea and serum creatinine < 1.5 times upper limit of normal (ULN) Creatinine clearance >/= 45 ml/min (calculated with Cockcroft-Gault Equation)

• Life expectancy of at least 3 months without any active treatment

• Female patients must either be postmenopausal, sterile (surgically or radiation- or chemically-induced), or if sexually active use an acceptable method of contraception during the study.

• Male patients must be surgically sterile or if sexually active must use an acceptable method of contraception during the study.

• Considered suitable to receive either regimen in the clinical judgement of the treating investigator.

Exclusion Criteria:

• Patients with only non-measurable lesions in the liver according to RECIST criteria

• Incomplete recovery from previous liver surgery, e.g. unresolved biliary tree obstruction or biliary sepsis or inadequate liver function

• Biliary stent in situ

• Main trunk Portal Vein Thrombosis (PVT)

• Ascites, even if controlled with diuretics. (A minor peri-hepatic rim of ascites detected at imaging is acceptable).

• Mixed hepatocellular carcinoma - intrahepatic cholangiocarcinoma (HCC-ICC) disease

• History of prior malignancy. Exceptions include in-situ carcinoma of the cervix treated by cone-biopsy/resection, non-metastatic basal and/or squamous cell carcinomas of the skin, recurrent intra-hepatic cholangiocarcinoma post local treatment or any early stage (stage 1) malignancy adequately resected with curative intent at least 5 years prior to study entry

• Suspicion of any bone metastasis/metastases or central nervous system metastasis/metastases on clinical or imaging examination.

• Prior internal or external radiation delivered to the liver.

• Pregnancy; breast feeding.

• Participation within 28 days prior to randomization, in an active part of another clinical study that would compromise any of the endpoints of the study.

• Evidence of ongoing active infection that may affect treatment feasibility or outcome.

• Prior Whipple's procedure.