Sintilimab+Bevacizumab+TACE vs. Lenvatinib+TACE for Advanced HCC

NCT05985798 | Recruiting Phase 3

• 1 other identifier: MIIR-13
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

This study is conducted to evaluate the efficacy and safety of sintilimab, bevacizumab plus TACE (Sin-Bev-TACE) compared with lenvatinib plus TACE (Len-TACE) for patients with advanced stage hepatocellular carcinoma (HCC).

Conditions

Hepatocellular Carcinoma Non-resectable

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  The time from date of randomization to death due to any cause.

  4 years

Secondary Outcomes (4)

• Progression free survival (PFS)

  4 years

• Objective response rate (ORR)

  4 years

• Disease control rate (DCR)

  4 years

• Adverse Events (AEs)

  4 years

Study Arms (2)

Sin-Bev-TACE

EXPERIMENTAL

Sintilimab, bevacizumab plus TACE

Drug: Sin-Bev-TACE

Len-TACE

ACTIVE COMPARATOR

Lenvatinib plus TACE

Drug: Len-TACE

Interventions

Sin-Bev-TACE DRUG

Sintilimab (200mg I.V. q3w) and bevacizumab (7.5mg/kg I.V. q3w) are administered at 3-7 days after the first TACE. The study treatment of sintilimab and bevacizumab will last up to 24 months. TACE can be repeated on demand.

Sin-Bev-TACE

Len-TACE DRUG

Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight \<60kg) P.O. qd will be started at 3-7 days after the first TACE. TACE will be repeated on demand.

Len-TACE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced HCC (BCLC stage C) with diagnosis confirmed pathologically or clinically
• Disease amenable to TACE
• No prior systemic therapy, TACE, transcatheter arterial radioembolization (TARE), transcatheter arterial embolization (TAE), hepatic arterial infusion chemotherapy (HAIC) or radiation therapy for HCC
• Child-Pugh class A
• Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
• Life expectancy of at least 3 months
• At least one measurable intrahepatic lesion
• Adequate organ and hematologic function
• Patients with active hepatitis B are allowed, but they need to receive antiviral treatment to achieve a HBV DNA\<10\^2 IU/mL
• Patients with hepatitis C need to finish the anti-HCV treatment

You may not qualify if:

• Tumor thrombus involving main portal vein or both the first left and right branch of portal vein
• Vena cava invasion
• Central nervous system metastasis
• History of hepatic encephalopathy
• History of organ and cell transplantation
• Uncontrolled ascites, hydrothorax or pericardial effusion
• Prior esophageal and/or gastric varices bleeding within 6 months prior to initiation of study treatment
• Presence of known severe (G3) varicose veins in endoscopy within 3 months before the first dose. Evidence of portal hypertension (including the finding of splenomegaly in imaging studies) with a high risk of bleeding assessed by the investigator
• Presence of any life-threatening bleeding events within the past 3 months, including the need for transfusion, surgery or local treatment, and continuous medication therapy
• Any arterial or venous thromboembolic events within 6 months, including myocardial infarction, unstable angina, cerebrovascular accident or transient cerebral ischemic attack, pulmonary embolism, deep vein thrombosis, or any other history of serious thromboembolism. Presence of implantable venous port or catheter-derived thrombosis, or superficial venous thrombosis, barring stable thrombosis following the conventional anticoagulation treatment. Prophylactic use of low-dose low-molecular-weight heparin (e.g., enoxaparin 40 mg/day) is permitted.
• A 10-day consecutive dosing of aspirin (\> 325 mg/day) or other drugs, e.g., dipyridamole and clopidogrel, known to inhibit the platelet function within 2 weeks before the first dose
• Uncontrolled hypertension after the optimal medical treatment, history of hypertensive crisis or hypertensive encephalopathy.
• Symptomatic congestive cardiac failure (NYHA Class II-IV). Symptomatic or poorly controlled arrhythmia. History of congenital long QT syndrome or corrected QTc \> 500 ms (calculated using Fridericia formula) during screening
• Serious hemorrhagic tendency or coagulopathy, or currently receiving thrombolytic therapy
• History of gastrointestinal perforation and/or fistula, history of bowel obstruction (including incomplete bowel obstruction requiring parenteral nutrition), extensive bowel resection (partial colectomy or extensive small bowel resection accompanied with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea within the past 6 months

Sponsors & Collaborators

• Second Affiliated Hospital of Guangzhou Medical University: lead
• Affiliated Hospital of Guangdong Medical University: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• Lecong Hospital, Shunde District, Foshan: collaborator
• First People's Hospital of Foshan: collaborator
• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: collaborator

Study Sites (1)

the Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Central Study Contacts

Mingyue Cai, Dr.

CONTACT

+86-20-34156205; cai020@yeah.net

Kangshun Zhu, Dr.

CONTACT

+86-20-34156205; zhksh010@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

CN (1)