HAIC Combined With Sintilimab Plus Bevacizumab Biosimilar for Advanced Hepatocellular Carcinoma (TASK-03)

NCT06860490 | Recruiting Phase 2

• 1 other identifier: TASK-03
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate HAIC combined with Sintilimab plus bevacizumab biosimilar for advanced hepatocellular carcinoma.

Conditions

Hepatocellular Carcinoma (HCC)

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  PFS is defined as the time from study treatment to disease progression or all-cause death as assessed by the investigator (whichever occurs first)

  max 24 months

Secondary Outcomes (7)

• Objective Response Rate (ORR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Disease control rate (DCR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Duration of Response (DOR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Time to Response (TTR) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 24 months

• Overall survival (OS) evaluated by the investigator per Response Evaluation Criteria in Solid Tumors Version 1.1

  max 42 months

Study Arms (2)

HAIC+sintilimab+bevacizumab

EXPERIMENTAL

HAIC in combination with Sintilimab plus bevacizumab biosimilar

Drug: Sintilimab; Drug: Bevacizumab Biosimilar; Procedure: HAIC

Sintilimab+bevacizumab

ACTIVE COMPARATOR

Sintilimab plus bevacizumab biosimilar

Drug: Sintilimab; Drug: Bevacizumab Biosimilar

Interventions

Sintilimab DRUG

Sintilimab will be administered by IV, 200 mg on day 1 of each 21 day cycle.

HAIC+sintilimab+bevacizumab; Sintilimab+bevacizumab

Bevacizumab Biosimilar DRUG

Bevacizumab biosimilar will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle.

HAIC+sintilimab+bevacizumab; Sintilimab+bevacizumab

HAIC PROCEDURE

FOLFOX regimen (oxaliplatin, 85 mg/m2 from hour 0-2 on day 1; leucovorin, 400 mg/m2 from hour 2-3 on day 1; and fluorouracil, 400 mg/m2 bolus at hour 3 on day 1 and 2,400 mg/m2 over 24 hours) via infusion via the hepatic artery. HAIC was repeated once every 3 weeks for up to four cycles. Sintilimab plus bevacizumab will be administered 1-3 days after HAIC.

HAIC+sintilimab+bevacizumab

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained.
• Age ≥ 18 years at time of study entry.
• Barcelona Clinic Liver Cancer stage C, or stage B not amenable to curative or locoregional therapies.
• HCC confirmed by radiology, histology or cytology.
• No prior systemic therapy for HCC.
• At least one measurable site of disease as defined by RECIST1.1criteria with spiral CT scan or MRI.
• Child-Pugh scores 5-7, performance status (PS) ≤ 2 (ECOG scale).
• Subjects with chronic HBV infection must have HBV DNA viral load \< 100 IU/mL at screening. In addition, they must be on antiviral therapy per regional standard of care guidelines prior to initiation of study therapy.
• Life expectancy of at least 12 weeks.
• Adequate blood count, liver-enzymes, and renal function: absolute neutrophil count ≥ 1,500/L, platelets ≥60 x103/L; Total bilirubin ≤ 3x upper normal limit; Aspartate Aminotransferase (SGOT), Alanine aminotransferase (SGPT) ≤ 5 x upper normal limit (ULN); International normalized ratio (INR) ≤1.25; Albumin ≥ 31 g/dL; Serum Creatinine ≤ 1.5 x institutional ULN or creatinine clearance (CrCl) ≥ 30 mL/min (if using the Cockcroft-Gault formula)
• Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial.
• Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment, adherence to contraceptive measures, scheduled visits and examinations including follow up.

You may not qualify if:

• Patients on a liver transplantation list or with advanced liver disease.
• History of cardiac disease, including clinically significant gastrointestinal bleeding within 4 weeks prior to start of study treatment
• Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months Prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
• Prior systemic anti-cancer therapy OR endocrine- OR immunotherapy.
• Prior treatment with HAIC.
• Radiotherapy administered less than 4 weeks prior to study treatment start.
• Major surgery within 4 weeks of starting the study treatment OR subjects who have not recovered from effects of major surgery.
• Patients with second primary cancer, except adequately treated basal skin cancer or carcinoma in-situ of the cervix.
• Immunocompromised patients, e.g. patients who are known to be serologically positive for human immunodeficiency virus (HIV).
• Previous treatment in the present study (does not include screening failure).
• Any condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study Treatment or interpretation of patient safety or study results, including but not limited to: a) history of interstitial lung disease b) Hepatitis B Virus (HBV) and Hepatitis C Virus (HCV) coinfection (i.e double infection) c) known acute or chronic pancreatitis d) active tuberculosis e) any other active infection (viral, fungal or bacterial) requiring systemic therapy f) history of allogeneic tissue/solid organ transplant g) diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of treatment. h) Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Exceptions: Subjects with vitiligo, hypothyroidism, diabetes mellitus type I or resolved childhood asthma/atopy are an exception to this rule. Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study. Subjects with Hashimoto thyroiditis, hypothyroidism stable on hormone replacement or psoriasis not requiring treatment are not excluded from the study. i) Live vaccine within 30 days prior to the first dose of treatment or during study treatment. j) History or clinical evidence of Central Nervous System (CNS) metastases Exceptions are: Subjects who have completed local therapy and who meet both of the following criteria: I. are asymptomatic and II. have no requirement for steroids 6 weeks prior to start of treatment. Screening with CNS imaging (CT or MRI) is required only if clinically indicated or if the subject has a history of CNS.
• Medication that is known to interfere with any of the agents applied in the trial.
• Any other efficacious cancer treatment except protocol specified treatment at study start.
• Patient has received any other investigational product within 28 days of study entry.
• Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-PD L1, anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor (TNFR) family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

sintilimab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Peng Wang, MD

CONTACT

86-21-64041990; peng_wang@fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: March 18, 2025
• Primary Completion (Estimated): March 10, 2027
• Study Completion (Estimated): March 10, 2028
• Last Updated: April 21, 2026

Record last verified: 2026-04

Locations

CN (1)