Sintilimab Plus Bevacizumab as Adjuvant Therapy in HCC Patients at High Risk of Recurrence After Curative Resection

Immunotherapy Clinical Trial

— DaDaLi  

Official title:

A Phase III, Randomized, Open-lable, Multi Center Study of Sintilimab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Curative Hepatic Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04682210
• Other study ID #: B2020-280-01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: December 2020
• Est. completion date: December 2024

Study information

• Verified date: December 2020
• Source: Sun Yat-sen University
• Contact: Zhongguo Zhou
• Phone: 020-87343585
• Email: 54757370[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open label, multi-center, randomized, controlled phase III study, to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in hepatocellular carcinoma (HCC) patients who are at high risk of recurrence after radical resection

Description:

There is no stardard adjuvant treatment for HCC. This study is to to evaluate the efficacy and safety of sintilimab plus bevacizumab as adjuvant therapy in HCC patients who are at high risk of recurrence after radical resection.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 246
• Est. completion date: December 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with a first diagnosis of HCC who have undergone a curative resection

• Radiologic evidence of disease free =4 weeks after complete surgical resection

• Full recovery from surgical resection or post-operative transarterial chemoembolization before randomization

• Randomization needs to occur within 12 weeks of the date of surgical resection

• High risk for HCC recurrence as protocol defined

• Child-Pugh Score, Class A

• ECOG performance status 0 or 1

• No prior systemic anticancer therapy for HCC

• Adequate hematologic and organ function

Exclusion Criteria:

• Known fibrolamellar HCC, sarcomatoid HCC or mixed cholangiocarcinoma and HCC

• Evidence of residual, recurrent, or metastatic disease at randomization

• History of hepatic encephalopathy or organ transplantation

• Patients who are in the waiting list for liver transplantation

• Patients with Vp4 portal vein thrombosis

• Prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or other immunotherapy

• Pregnant or lactating women

Related Conditions & MeSH terms

• Adjuvant Therapy
• HCC
• Immunotherapy
• Recurrence

Intervention

Drug:
• Sintilimab
Sintilimab 200mg IV Q3W
• Bevacizumab
Bevacizumab 7.5mg/kg IV Q3W

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-free Survival (RFS)	RFS is defined as the time from randomization to the first documented occurrence of local, regional, or metastatic HCC as determined by the investigator, or death due to any cause (whichever occurs first).	up to 36 months after randomization
Secondary	Overall Survival (OS)	OS is defined as the time from the date of randomisation until death due to any cause	up to 48 months after randomization
Secondary	RFS Rate at 12 and 24 months	RFS rate defined as the proportion of patients without recurrence or death from any cause at 12 and 24 months after randomization.	at 12 and 24 months after randomization
Secondary	OS Rate at 24 and 36 Months	OS rate defined as the proportion of patients who have not experienced death from any cause at 24 and 36 months after randomization.	at 24 and 36 months after randomization
Secondary	TTR(time to recurrence)	TTR is defined as the time the date of randomisation until first documented disease recurrence.	up to 36 months after randomization
Secondary	Adverse Events (AEs)	The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v5.0 from the date of randomization to 90 days after last dose of study treatment.	up to 48 months after randomization