Prospective Cohort Study on the Clinical Trajectory of Resected Hepatocellular Carcinoma

• Register: ClinicalTrials.gov
• Last refreshed on: 21 June 2021
• Main ID: NCT03267641
• Date of registration: 28/08/2017
• Prospective Registration: No
• Primary sponsor: National Cancer Centre, Singapore
• Public title: Prospective Cohort Study on the Clinical Trajectory of Resected Hepatocellular Carcinoma PLANET
• Scientific title: A Multi-National Cohort Study On The Impact Of Intra-Tumoural Genomic Heterogeneity And The Immune Micro-Environment On The Clinical Trajectory Of Resected Hepatocellular Carcinoma
• Date of first enrolment: May 16, 2016
• Target sample size: 86
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03267641
• Study type: Observational

Countries of recruitment

Malaysia, Philippines, Singapore, Thailand

Contacts

• Name: Pierce Chow, MD, PhD
• Affiliation: National Cancer Centre, Singapore

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male and female patients, 21 to 80 years of age at the time of signature of the
informed consent form.

2. Histologically proven HCC after liver resection. Combined
hepatocellular-cholangiocarcinoma can be included.

3. HCC limited to the liver with no extra-hepatic metastasis on CT or MRI of the abdomen
and chest (defined as lymph node <2 cm, lung nodules < 1 cm, farther lymph nodes < 2
cm) according to the AASLD criteria65.

4. R0 or R1 resection on histology.

5. Eligibility according to tumour size:

1. Large tumour >= 5 cm (preferred)

2. Smaller tumours >=2cm and < 5cm

3. Multifocal tumours - maximum of 3 total tumours with size >=2cm detected from
CT-scan. Detection of <1cm tumour intra-operatively or upon histologic
examination following resection can be ignored. For multiple satellite nodules
(>=2cm) that are detected intraoperatively, harvest ALL satellite nodules (>/=
2cm). DNA/RNA will be extracted from cases confirmed to be
HCC/hepato-cholangiocarcinoma by histology. A MAXIMUM of 3 samples with the best
quality are to be used for the analysis.

6. Child-Pugh = 7 points without clinical ascites before surgery.

7. ECOG performance status 0-1 before surgery.

8. Scheduled for liver resection within 6 weeks.

9. The patient has received no anti-cancer specific treatment for HCC eg. previous liver
resection, loco-regional therapy (e.g. RFA, TACE, SIRT), radiotherapy, immunotherapy,
chemotherapy or neo-adjuvant chemotherapy other than the planned surgery. However,
patient who has received previous HCC resection more than 5 years ago is deemed to
have a de-novo liver tumour and therefore can be included.

10. Adequate bone-marrow reserve, renal function and hepatic function as assessed by
standard laboratory criteria:

- Absolute neutrophil count = 1.0 x 10^9/L

- Platelet count = 50 x 10^9/L

- Haemoglobin = 9.0 g/dL

- INR = 2.0

- Serum creatinine = 1.5 times the Upper Limit of Normal (ULN)

- Albumin = 2.5 g/dL

- Total bilirubin = 1.5 times the ULN

- Alanine transaminase (ALT) = 2.5 times the ULN

- Aspartate transaminase (AST = 2.5 times the ULN

Exclusion Criteria:

1. Single lesion < 2 cm at the time of tumour resection.

2. The patient has previous or concomitant malignancies at other sites, except
effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or
effectively treated malignancy that has been in remission for over 5 years and highly
likely to have been cured.

3. Encephalopathy

4. The patient has received a major organ allograft.

5. The patient is known to be positive for the Human Immunodeficiency Virus (HIV).

6. The patient has an uncontrolled bleeding disorder.

7. The patient has uncontrolled congestive heart failure or hypertension, unstable heart
disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia
at the time of enrolment.

8. The patient has psychiatric or addictive disorders that may compromise his/her ability
to give informed consent, or to comply with the study procedures.

9. The patient has other concurrent severe medical problems, unrelated to the malignancy,
that would significantly limit full compliance with the study or expose the patient to
unacceptable risk.

10. The patient has received any investigational or non-registered medicinal product (drug
or vaccine) within the 30 days preceding the date of enrolment, or plans to receive
such a drug during the study period.

11. For female patients: the patient is pregnant or lactating.

12. Insufficient DNA/RNA for genome analysis at baseline

13. Insufficient cells for immunology analysis at baseline (Singapore sites only)



Age minimum: 21 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hepatocellular Carcinoma

Primary Outcome(s)

Time to recurrence [Time Frame: From date of Complete Response (CR) to first recurrence of HCC, up to 3 years]

Secondary Outcome(s)

Disease-free Survival [Time Frame: From date of CR to first recurrence of HCC or death, due to any cause, up to 3 years]

Disease-free Specific Survival [Time Frame: From date of CR to first recurrence of HCC or death, due to HCC, up to 3 years]

Overall Survival [Time Frame: From diagnosis to date of death due to any cause, up to 3 years]

Secondary ID(s)

AHCC07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Singapore Clinical Research Institute