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External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.

Phase 1/Phase 2
18 Years
Open (Enrolling)
Liver Cancer

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Trial Information

External Beam Radiotherapy for Unresectable Hepatocellular Carcinoma. A Multicenter Phase I/II Trial.


- To assess the feasibility and safety of radiotherapy (RT) in patients with
hepatocellular carcinoma. (Phase I)

- To assess the safety and efficacy of RT in these patients. (Phase II)

- To generate reproducible peptide patterns of the serum proteome or specific serum sub
proteomes in these patients.

- To assess changes in the proteome or sub proteome patterns after RT in these patients.

- To detect peptides that discriminate between before and after RT in these patients.

- To identify these discriminating peptides in these patients.

OUTLINE: This is a multicenter, phase I dose-escalation study followed by a phase II study.

Patients undergo radiotherapy (RT) once daily, five days a week, for 6 weeks.
Intensity-modulated, 3-dimensional conformal, or fractionated stereotactic RT may be used.

After completion of study therapy, patients in the phase I portion are followed for 1 year
and patients in the phase II portion are followed for 3 years.

Inclusion Criteria


- Histologically, cytologically, or radiologically confirmed hepatocellular carcinoma

- Clinical stage T2-4, N0-1, M0 (stage II, IIIA, IIIB, IIIC) OR unresectable T1,
N0-1, M0 (stage I) disease

- M1 disease allowed in phase I if at least 90% of the tumor load (volume) is
in the liver

- Measurable disease (at least one liver lesion that can be measured in at least one
dimension as ≥ 10 mm in multislice CT scan/MRI)

- Volumetry of liver tumor and residual liver tissue: residual liver volume (= total
liver volume - gross tumor volume) has to be ≥ 800 mL and ≥ 40% of total liver volume

- No operable disease (with curative intent or planned liver transplantation)

- No presence of clinical ascites


- WHO performance status 0-2

- Cirrhosis Child-Pugh class A or B (Child-Pugh score of ≤ 9)

- Hemoglobin ≥ 100 g/L

- ANC ≥ 1,200/mm³

- Platelet count ≥ 50,000/mm³

- ALT and AST ≤ 7 times upper limit of normal (ULN)

- AP ≤ 10 times ULN

- Bilirubin ≤ 50 μmol/L

- INR ≤ 2

- Creatinine clearance ≥ 50 mL/min

- Functional left kidney (scintigraphy mandatory for phase I, phase II only if

- Lipase ≤ 2 times ULN (phase I only)

- Able to tolerate proton-pump inhibitors or H2 antagonists during radiation therapy

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 4 months after
completion of study therapy

- No prior malignancy allowed, except for the following:

- Adequately treated cervical carcinoma in situ

- Adequately treated localized nonmelanoma skin cancer

- Any other malignancy from which patient has been disease-free for 5 years

- No presence of medically uncontrolled encephalopathy

- No myocardial infarction within the past 6 months

- No esophageal varices ≥ grade 3, with red signs, or bleeding within the past 3 months

- No symptoms of colitis, enteritis, esophagitis, fistula, gastritis, ileus, necrosis,
perforation, stricture, or ulcer

- No severe anorexia, constipation, dehydration, diarrhea, or vomiting

- No serious underlying medical condition that, in the opinion in the investigator,
would preclude study participation (e.g., active autoimmune disease or uncontrolled

- Portal vein thrombosis allowed

- No psychiatric disorder precluding understanding of information on study related
topics or giving informed consent

- No nutritional intake < 1500 calories per day (corrected)

- No weight loss ≥ 15 % within the past 3 months


- At least 8 weeks since prior transarterial chemoembolization (TACE), radiofrequency
ablation, or radiotherapy (RT) unless progressive disease was documented after this

- At least 21 days since prior and no other concurrent treatment with experimental

- At least 21 days since prior and no other concurrent treatment on another clinical

- At least 21 days since prior and no other concurrent anticancer therapy

- No prior RT to the abdomen or caudal chest

- Prior RT to pelvis allowed

- Prior RT to chest must be above D5 vertebra

- Portal vein embolization ligation or pre-RT TACE allowed

- No concurrent treatment with steroids or non-steroidal anti-inflammatory drugs during
RT (proton-pump inhibitor allowed)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose-limiting toxicity (Phase I)

Outcome Time Frame:

during RT or within 30 days after the last RT dose, is a DLT.

Safety Issue:


Principal Investigator

Diana Naehrig, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Unviersitaetsspital Basel


Switzerland: Ethikkommission

Study ID:

SAKK 77/07



Start Date:

November 2008

Completion Date:

December 2016

Related Keywords:

  • Liver Cancer
  • advanced adult primary liver cancer
  • localized unresectable adult primary liver cancer
  • adult primary hepatocellular carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular