CompletedPhase 2

Neoadjuvant Anti-PD1 in HCC

Hong Kong20 participantsStarted 2020-07-03

Plain-language summary

This is a phase 2, single-arm trial designed to assess the clinical benefit of treatment with nivolumab administered in patients with untreated, borderline resectable HCC.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed written informed consent form prior to the screening procedures.
✓. Age ≥ 18 years.
✓. Histological proof of HCC.
✓. Willingness to undergo a pre-dosing fresh tumour biopsy. Patients for whom fresh biopsy may not be feasible will be ineligible for enrollment.
✓. Intermediate or locally-advanced HCC (according to HKLC tumour status categorization) with the option of resection for potential cure as assessed by surgeon.
✓. Child-Pugh score ≤ 7 with no symptomatic ascites or ascites requiring therapeutic paracentesis.
✓. ECOG performance status ≤ 1.
✓. Life expectancy of ≥ 12 weeks.

Exclusion criteria

✕. Patients who have history of organ transplantation.
✕. History of allergy or hypersensitivity to study drug components.
✕. Patients who have active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition adequately treated with hormonal replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger or deemed by the investigator not to affect safety assessment.
✕. Patients with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to start of study treatment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
✕. Patients who have received prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or any other antibody targeting T cell co-regulatory pathways).
✕. Receipt of any cancer therapy in the pre-operative period.
✕. Treatment with botanical preparations (e.g., herbal supplements or traditional Chinese medicine) intended for general health support or to treat the disease under study within 2 weeks prior to treatment.
✕. Active, acute, or chronic clinically significant infections requiring therapy with the exception of hepatitis B or C virus infection. Patients with chronic HBV infection must be on antiviral therapy and have HBV DNA \< 500 IU/ml. Active or chronic co-infection with hepatitis B and C, or hepatitis B and D is not allowed.

What they're measuring

Pathological tumour response rate

Timeframe: After surgery (normally 6 weeks after the start of nivolumab)

Trial details

NCT IDNCT05471674

SponsorDr Tan-to CHEUNG

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

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