Sintilimab Plus Bevacizumab Biosimilar as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Yat-sen University
About this trial
Surgical resection is the preferred therapeutic modality for patients with resectable hepatocellular carcinoma (HCC). However, the recurrence rate of HCC remains up to 70%. Neoadjuvant therapy for HCC could potentially reduce the risk of postoperative recurrence and prolong overall survival. Nevertheless, there is no standard neoadjuvant treatment regimen for HCC to date. In recent years, targeted therapy and immunotherapy are proved to improve the prognosis of advanced HCC patients. Previous study (ORIENT-32) has confirmed that, compared with sorafenib, sintilimab combined with bevacizumab biosimilar can delay tumor progression, reduce the risk of death, and exhibit a favorable safety profile in patients with advanced HCC. Therefore, we conducted a prospective, single-arm phase II study to investigate the efficacy of sintilimab combined with a bevacizumab biosimilar as neoadjuvant therapy in patients with resectable HCC beyond the Milan criteria.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to provide informed consent and willing to sign an approved consent form;
Aged ≥ 18 years;
Clinically diagnosed or pathologically confirmed resectable hepatocellular carcinoma beyond the Milan criteria (CNLC Ib-IIa);
No prior anti-HCC treatment;
Disqualifiers
Known as cholangiocarcinoma (ICC) or mixed hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, and hepatic fibrolamellar carcinoma;
History of organ transplantation or hepatic encephalopathy
Pleural fluid, ascites, and pericardial effusion with clinical symptoms requiring drainage
History of esophageal or gastric variceal bleeding caused by portal hypertension within the past 6 months; Documented severe (Grade 3) varices identified by endoscopy within 3 months prior to enrollment; Evidence of portal hypertension and assessed by the investigator as being at high risk of bleeding.
Trial design
Design model
Single group
Treatments tested in this trial
sintilimab combined with bevacizumab biosimilar
DrugDrug: Sintilimab: 200mg IV Q3W D1 (3 cycles) Drug: Bevacizumab Biosimilar: 15mg/kg, IV, Q3W, D1 (2 cycles)
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: sintilimab combined with bevacizumab biosimilarExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1-year recurrence free survival rate
Defined as the proportion of patients who remain free from any tumor recurrence or death within 1 year after liver resection.
Time frame
Up to 2 years2
Adverse Events (AEs)
Defined as the proportion of patients with AEs assessed by NCI CTCAE v5.0;
Time frame
Up to 2 yearsSecondary outcomes
1
R0 resection rate
Defined as the proportion of patients received R0 resection
Time frame
Up to 2 years2
pathological complete response
Defined as the proportion of patients who had pathological complete response
Time frame
Up to 2 years3
major pathological response
Defined as the proportion of patients who had major pathological response
Time frame
Up to 2 years4
Overall survival
Defined as the interval from the date of enrollment to the date of death or to the date of last follow-up (whichever occurs first)
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov