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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 (Jun 2026). This Phase 2 trial studies Cadonilimab for hepatocellular carcinoma.

Phase 2RecruitingFei GaoNCT05882370Data as of Jun 2026Location: China

Treatment: CadonilimabThe 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.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Cadonilimab

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)

Demographics

Ages ≤ 75

Prior therapy

Max 1 prior line

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.

Frequently asked questions

Is NCT05882370 currently recruiting?

Yes, this trial is currently recruiting patients.

Are there prior therapy exclusions?

Yes. Prior targeted therapy, immunotherapy, anti-PD-1 therapy disqualifies patients from enrollment.

What disease stage is eligible?

Stage BCLC-C is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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