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

Sun Yat-sen University

Status and phase: Not yet enrolling; Phase 3

Conditions: Immunotherapy; Adjuvant Therapy; HCC

Treatments: Drug: Bevacizumab; Drug: Sintilimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04682210

B2020-280-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 246 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

246 participants in 2 patient groups

Arm A

Experimental group

Description:

sintilimab 200mg + bevacizumab 7.5mg/kg IV Q3W

Treatment:

Drug: Sintilimab

Drug: Bevacizumab

Arm B

No Intervention group

Description:

Active surveillance