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EMPHATICNCT06434493

Evaluation of Combined Modality Protons and Hepatic Transplantation for Hilar Cholangiocarcinoma

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 1 year 5 months later.

See at-risk trials from The Christie NHS Foundation Trust

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Nov 1, 2029 Show 8 more changesShow less
    • Recruitment opened
    • Start date changed from estimate of Nov 1, 2024 to Oct 3, 2025
    • Eligibility criteria expanded, about 18 words
    • Study sites: 0 to 2
    • Interventions: Cisplatin & Gemcitabine intravenous chemotherapy (Drug), Concurrent oral capecitabine chemotherapy (Drug), Orthotropic Liver Transplant… to Cisplatin & Gemcitabine intravenous chemotherapy (Drug), Concurrent oral capecitabine chemotherapy (Drug), Orthotropic Liver Transplant…
    • Secondary endpoints: details revised at 1 of 16 entries
    • Study description revised
    • Publications: details revised at 3 of 3 entries
  2. Start date: Jun 1, 2024 to Nov 1, 2024
    • Primary completion date: Jan 1, 2028 to Jun 1, 2028
    • Study completion date: Jan 1, 2029 to Jun 1, 2029
    v2
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Incidence of Common Toxicity Criteria for recording Adverse Events (CTCAE) Grade 3 and above toxicity
Timeframe: Up to 90 days post neoadjuvant chemo-radiation.
Proportion of patients who undergo a successful liver transplant
Timeframe: 90 days post transplant.

Secondary (16)

Number of patients completing planned radiotherapy
Incidence of severe treatment related side effects
1 year post completion of neoadjuvant therapy cancer-related mortality
1 year post transplant overall survival
1 year post transplant graft survival
Show 11 moreShow less
1 year post listing patient survival
Disease free survival from transplant
Recurrent cancer within 6 months of transplant
Cancer control at time of transplant
Cancer control at time of removal from transplant list
Transplant complication rates
Patient pathway
Time to completion of neoadjuvant chemo-PBT treatment to liver transplant
Time spent on transplant waiting list
Referral rates
Recruitment rates

Arms and interventions

Proton Beam TherapyExperimental

All patients to be offered neoadjuvant proton beam therapy to a dose of 45 Gray (Gy) in 15 fractions over 3 weeks, with a tumour boost to 67.5 Gray (Gy), and alongside concurrent oral capecitabine 625mg/m2 twice daily on radiation days.

Radiation: Proton Beam Therapy

Drugs: Concurrent oral capecitabine chemotherapy, Cisplatin & Gemcitabine intravenous chemotherapy

Procedures: Orthotropic Liver Transplant

Sites

2 sites in 1 country