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CompletedLast updated: 4 April 2024

SIRCCA: This phase III trial is evaluating the benefit of adding radiotherapy (SIRT) to systemic chemotherapy (CIS-GEM) as a first line treatment in patients with Intrahepatic Cholangiocarcinoma (a type of liver cancer)Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

Clinical summary

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. Randomized patients will be followed until death, withdrawal of consent, or until end of study.

Conditions

This trial is treating patients with Intrahepatic Cholangiocarcinoma.

Cancer

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

SIRCCA

More information

Trial Identifiers

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Trial sponsor

Sirtex Medical Limited

Scientific Title

Prospective, Multicenter, Randomized, Controlled Study Evaluating SIR-Spheres Y-90 Resin Microspheres Preceding Cisplatin-gemcitabine (CIS-GEM) Chemotherapy Versus CIS-GEM Chemotherapy Alone as First-line Treatment of Patients With Unresectable Intrahepatic Cholangiocarcinoma

Eligibility

Inclusion

  • 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 LN </= to 2 cm and/or para aortic LN </= to 1.5 cm in longest diameter, and/or up to 2 indeterminate lung lesions < 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 umol/L (1.75 mg/dL) Albumin >/= 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

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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