OncoMatch/Clinical Trials/NCT07018518
PIN in Combination With Anti-PD1 in Previously Treated Primary Hepatocellular Carcinoma
Is NCT07018518 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies PIN +anti-PD1 for hepatocellular carcinoma.
Treatment: PIN +anti-PD1 — In this single-center,open-label, phase I study, the safety and efficacy of PIN in combination with programmed cell death protein antibody (anti-PD1) therapeutic regimen will be evaluated in patients with refractory primary advanced hepatocellular carcinoma(HCC) . A total of 25 to 30 patients are planned to be enrolled and receive PIN plus anti-PD1 combined treatment. It aims to: 1).assess the safety and antitumor effects of the above combined treatment regimen. 2).detect the dynamic changes and molecular characteristics of PIN-induced CD8+ T cells with special phenotype in peripheral blood (PB) and transformation of tumor microenvironment (TME) after the treatment with PIN. 3).evaluate the immunological or clinical predictive biomarkers for toxicity and efficacy.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard therapies (including targeted therapy and immunotherapy) — advanced/metastatic
refractory/relapsed after and/or intolerant of standard therapies (including targeted therapy and immunotherapy) or for which no subsequent standard therapy exists
Cannot have received: cytotoxic chemotherapy
Received cytotoxic chemicals...within 4 weeks or 5 half-lives before enrollment
Cannot have received: monoclonal antibody
Received...monoclonal antibodies...within 4 weeks or 5 half-lives before enrollment
Cannot have received: immunotherapy
Received...immunotherapy...within 4 weeks or 5 half-lives before enrollment
Cannot have received: radiation therapy
Received radiotherapy within 3 months before enrollment
Lab requirements
Blood counts
ANC ≥ 1 x 10^9/L, Platelet count ≥50 x 10^9/L, Hgb ≥ 80g/L
Kidney function
Serum creatinine ≤1.5 ULN or creatinine clearance ≥60 mL/min
Liver function
AST and ALT ≤5 x ULN; Total serum bilirubin ≤3 x ULN
Cardiac function
Ejection fraction ≥ 50%, no evidence of pericardial effusion by ECHO, no clinically significant ECG findings
Adequate organ function as defined by the following criteria: ANC ≥ 1 x 10^9/L, Platelet count ≥50 x 10^9/L, Hgb ≥ 80g/L; Serum creatinine≤1.5 ULN or creatinine clearance ≥60 mL/min; AST and ALT ≤5 x ULN; Total serum bilirubin ≤3 x ULN; Cardiac ejection fraction ≥ 50%, no evidence of pericardial effusion as determined by an echocardiogram (ECHO), and no clinically significant electrocardiogram (ECG) findings; INR ≤ 1.5 x ULN, APTT ≤ 1.5 x ULN; Baseline oxygen saturation >91% on room air.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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