OncoMatch/Clinical Trials/NCT05882370
TIPS Plus Cadonilimab in Advanced HCC with Tumor Thrombosis-associated Portal Hypertension:a Prospective, Single-arm, Phase II Study
Is NCT05882370 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cadonilimab for hepatocellular carcinoma.
Treatment: Cadonilimab — The purpose of this study is to evaluate the efficacy and safety of transjugular intrahepatic portosystemic shunt (TIPS) plus Cadonilimab (a PD-1/CTLA-4 bispecific antibody) in advanced hepatocellular carcinoma (BCLC-C Stage) accompanied by tumor thrombosis-associated portal hypertension.
Check if I qualifyExtracted eligibility criteria
Cancer type
Hepatocellular Carcinoma
Disease stage
Required: Stage BCLC-C (BCLC)
BCLC-C stage accompanied by tumor thrombosis-associated portal hypertension
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: targeted therapy
Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past
Cannot have received: immunotherapy
Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past
Cannot have received: anti-PD-1 therapy
The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1
Cannot have received: molecular targeted therapy (apatinib)
or has previously received apatinib therapy
Cannot have received: radiotherapy
Exception: less than 4 weeks before the study medication
Patients who have previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication
Cannot have received: chemotherapy
Exception: less than 4 weeks before the study medication
Patients who have previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication
Cannot have received: hormone therapy
Exception: less than 4 weeks before the study medication
Patients who have previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication
Cannot have received: surgery
Exception: less than 4 weeks before the study medication
Patients who have previously received radiotherapy, chemotherapy, hormone therapy, and surgery, after the completion of the treatment (last medication) and less than 4 weeks before the study medication
Cannot have received: molecular targeted therapy
Exception: less than 5 drug half-lives before the study medication
molecular targeted therapy (including other oral targeted drugs used in clinical trials) is less than the first study medication <5 drug half-lives
Lab requirements
Blood counts
Absolute neutrophil count ≥ 1.5×10^9/L; Platelet ≥ 50×10^9/L; Hemoglobin ≥ 60 g/L
Kidney function
Serum creatinine ≤ 1.5×ULN
Liver function
Child-Pugh score ≤ 13 points; Bilirubin ≤ 2×ULN; ALT and AST ≤ 5×ULN; Serum albumin ≥ 28 g/L
Cardiac function
QTc ≤ 450ms (male); QTc ≤ 470ms (female); NYHA level <2 heart failure; no unstable angina; no MI within 1 year; no clinically significant arrhythmia requiring intervention
The functions of vital organs meet the following requirements... see inclusion 10 and exclusion 9
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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