Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC (NCT04912765) | Clinical Trial Compass
RecruitingPhase 2
Neoantigen Dendritic Cell Vaccine and Nivolumab in HCC and Liver Metastases From CRC
Singapore60 participantsStarted 2021-04-15
Plain-language summary
This is a single arm phase II study of adjuvant intra-dermal NA DC vaccine combined with intravenous nivolumab in patients with resectable HCC (group A) or CRLM (group B) planned for curative surgery (with/without local ablation).
Who can participate
Age range21 Years
SexALL
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Inclusion criteria
✓. Up to three tumours, at least one with a diameter \> 3cm
✓. More than three tumours, none with a diameter \> 5 cm
✓. Recurrent HCCs are permitted if they were previously treated with curative intent (e.g. by surgery or ablative methods) and with liver-limited recurrence fulfilling criteria (a) and (b)
✓. There are no other sites of metastases aside from the liver confirmed by imaging studies (contrast-enhanced CT chest, abdomen and pelvis or contrast-enhanced CT chest and MRI abdomen and pelvis and other suspected sites of disease, and bone scans if indicated) at least 12 weeks prior to study enrolment AND
✓. The liver metastases are amenable and planned for curative surgical resection with or without the addition of local ablation AND
✓. The primary colorectal tumour had previously been resected or is amendable and planned for surgical resection.
✓. Non-HBV non-HCV related HCC
✓. HBV-HCC:
Exclusion criteria
✕. Known fibrolamellar HCC, sarcomatoid HCC, or mixed cholangiocarcinoma and HCC.
✕. Any evidence of tumour metastasis or co-existing malignant disease.
✕. Participants showing evidence of macrovascular invasion on imaging tests.
✕
What they're measuring
1
24-month Relapse Free Survival
Timeframe: Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years
2
Induced immune response against vaccinated NAs
Timeframe: Time from liver resection to first documented disease recurrence or death by any cause, up to 2 years