Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A … (NCT06031285) | Clinical Trial Compass
RecruitingPhase 2
Perioperative Sintilimab Plus Bevacizumab Biosimilar and TACE-HAIC for HCC Patients With PVTT: A Phase-2 Clinical Trial
China43 participantsStarted 2023-09-01
Plain-language summary
Although 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Clinically diagnosed or pathologically confirmed resectable advanced hepatocellular carcinoma, at least one measurable focus without local treatment (according to mRECIST requirements);
* Child-Pugh score ≤ 6 points (Child-Pugh A);
* BCLC staging is stage C; PVTT classification is combined with PVTT (VP1-2), and a single lesion in the liver (or multiple lesions with diameter) ≤ 10cm of primary liver cancer.
* Newly diagnosed patients who have not received targeted therapy or immunotherapy in the past;
* ECOG score: 0～1 (see Annex 1 for ECOG scoring criteria);
* Expected survival period ≥ 12 weeks;
* 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):
Exclusion Criteria:
* The patient has any active autoimmune disease or a history of autoimmune disease;
* The patient is using systemic therapy or local treatment for HCC before enrollment;
* Severe allergic reaction to other monoclonal antibodies;
* Those with a known history of central nervous system metastasis or hepatic encephalopathy;
* Patients whose liver tumor burden is greater than 50% of the total liver volume, or who have received liver transplantation in the past;
* Ascites with clinical symptoms, those who need puncture, drainage, or those who have received ascites drainage within the past 3 months, except those who have only a small amount of a…