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OncoMatch/Clinical Trials/NCT06031285

Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial

Is NCT06031285 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Sintilimab for hepatocellular carcinoma.

Phase 2RecruitingSun Yat-sen UniversityNCT06031285Data as of Jun 2026Location: China

Treatment: SintilimabAlthough resection provided survival benefit for selected HCC patients with PVTT, the recurrence rate is still high for those patients. It is still unknown whether perioperative Sintilimab, a PD-1antibody, plus bevacizumab biosimilar and TACE-HAIC will improve the survival for those patients. We initialed this phase 2 clinical trial to prove the perioperative therapy.

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Extracted eligibility criteria

Treatments studied

Immunotherapy

Sintilimab

Cancer type

Hepatocellular Carcinoma

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

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 antibody therapy

The patient has previously received other anti-PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1

Lab requirements

Blood counts

The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration)

Kidney function

The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration)

Liver function

Child-Pugh score ≤ 6 points (Child-Pugh A)

Cardiac function

Uncontrolled cardiac clinical symptoms or diseases, such as: NYHA level 2 or higher heart failure, unstable angina pectoris, myocardial infarction occurred within 1 year, clinically significant supraventricular or ventricular arrhythmia requires treatment or intervention , QTc>450ms (male); QTc>470ms (female)

Child-Pugh score ≤ 6 points (Child-Pugh A); The functions of vital organs meet the following requirements (no blood components, cell growth factors and other corrective treatment drugs are allowed within 14 days before the first administration)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT06031285 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

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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