Selective Internal Radiation Therapy and Capecitabine (chemotherapy) treatment for liver cancer

A multicenter open-label randomized controlled prospective phase II study evaluating the efficacy of Selective Internal Radiation Therapy (Yttrium-90 glass microspheres) combined with Capecitabine in the neoadjuvant setting of Operable intrahepatic CHOlangiocarcinoma - S7-PRODIGE-SIROCHO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001575-16-FR

Enrollment

Registered

2021-09-02

Start date

2021-11-29

Completion date

Unknown

Last updated

2024-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients having operable intrahepatic cholangiocarcinoma MedDRA version: 20.0 Level: LLT Classification code 10073077 Term: Intrahepatic cholangiocarcinoma System Organ Class: 100000004864

Interventions

Trade Name: CAPECITABINE ACCORD Product Name: CAPECITABINE ACCORD Pharmaceutical Form: Coated tablet Trade Name: THERASPHERE Product Name: THERASPHERE Pharmaceutical Form: Radiopharmaceutical precurs

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age > 18 years-old, ECOG Performance Status 5cm - Multifocal lesion deemed resectable, validated by a Surgical Review Board Patient information and signature of informed consent or legal representative. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 22

Exclusion criteria

Exclusion criteria: Cirrhosis, Inadequate haematological, hepatic, renal and coagulation functions: - Haemoglobin = 8,5 g/dl - Neutrophils 34 µmol/L - ASAT/ALAT > 5 x ULN - Creatinine clearance 2,3 ULN - TCA > 1,5 x ULN - Uracil blood level >16 ng/mL Respiratory insufficiency, Comorbidity precluding surgical resection, such as severe heart disease Other invasive malignancies in the past 3 years, Patient participate to an interventional study that tests another medical intervention before surgery.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess efficacy of the combination of neoadjuvant SIRT and capecitabine in neoadjuvant setting of patients with a resectable cholangiocarcinoma;Secondary Objective: To assess the safety of the neoadjuvant combination of SIRT and capecitabine To assess the quality of life related to health of the patients treated by the combination of SIRT and capecitabine;Primary end point(s): Frequency of subjects with adequate surgical margins, defined as the number of resections AND margin = 5mm; Frequency of subjects actually resected; Frequency of subjects with R0 and R1 resection; Frequency of subjects with an observed objective response; Mean percentage of tissue with necrosis in resected specimen; Disease-Free Survival (DFS); Overall Survival (OS). ;Timepoint(s) of evaluation of this end point: Disease-Free Survival (DFS) : will be measured from surgery to, depending on what comes first, (local or distant) recurrence or death from any cause ; Overall Survival (OS) : will be measured from randomization to death from any cause.	—

Measure

Time frame

Main Objective: To assess efficacy of the combination of neoadjuvant SIRT and capecitabine in neoadjuvant setting of patients with a resectable cholangiocarcinoma;Secondary Objective: To assess the safety of the neoadjuvant combination of SIRT and capecitabine To assess the quality of life related to health of the patients treated by the combination of SIRT and capecitabine;Primary end point(s): Frequency of subjects with adequate surgical margins, defined as the number of resections AND margin = 5mm; Frequency of subjects actually resected; Frequency of subjects with R0 and R1 resection; Frequency of subjects with an observed objective response; Mean percentage of tissue with necrosis in resected specimen; Disease-Free Survival (DFS); Overall Survival (OS). ;Timepoint(s) of evaluation of this end point: Disease-Free Survival (DFS) : will be measured from surgery to, depending on what comes first, (local or distant) recurrence or death from any cause ; Overall Survival (OS) : will be measured from randomization to death from any cause.

—

Secondary

Measure	Time frame
Secondary end point(s): Frequency of adverse events ; Scores from self-questionnaires.;Timepoint(s) of evaluation of this end point: Frequency of adverse events : from inclusion to 6 months after surgery ; Scores from self-questionnaires : from baseline until the end of follow-up.	—

Countries

France

Contacts

Public ContactCellule Promotion de la DRC

Centre Régional de lutte contre le cancer Eugène Marquis

promotion@rennes.unicancer.fr330299253165

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026