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NCT Number: NCT05976568

A Study of QL1706 in Combination With Bevacizumab and/or Chemotherapy as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

The purpose of this study is to assess the efficacy and safety of QL1706 in combination with bevacizumab and/or chemotherapy versus sintilimab in combination with bevacizumab as first-line treatment in patients with advanced hepatocellular carcinoma.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nanjing Tianyinshan Hospital, Nanjing, Jiangsu, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects participate voluntarily and sign informed consent.
  • Age ≥ 18 and ≤ 80 years old, male or female.
  • Histological or cytological or clinical diagnosis of HCC
  • Barcelona Clinic Liver Cancer stage C. BCLC stage B, not suitable for radical surgery and/or local treatment.
  • No prior systemic therapy for HCC.
  • Child-Pugh ≤7 , no history of hepatic encephalopathy.

Exclusion criteria

  • Histologically or cytologically documented fibrolamellar hepatocellular carcinoma, sarcoma-like hepatocellular carcinoma, cholangiocarcinoma, etc.
  • History of malignancy other than HCC within 5 years prior to the start of study treatment.
  • History of liver transplantation, or planned to receive liver transplantation.
  • Moderate or severe ascites with clinical symptoms that require drainage, uncontrolled or moderate or severe pleural and pericardical effusion.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Involvement of both the main portal vein and the left and right branches by portal vein tumor thrombus, or of both the main trunk and the superior mesenteric vein concurrently, or of inferior vena cava.

Treatment and study plan

QL1706

Drug

7.5 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

Bevacizumab

Drug

15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle

Oxaliplatin injection

Drug

85 mg/m2 administered as IV infusion on Day 1 of each 21-day cycle

Capecitabine

Drug

1000 mg/m2 orally twice daily for 14 days continuous dosing followed by a 7-day break of each 21-day cycle

Sintilimab

Drug

200 mg administered as IV infusion on Day 1 of each 21-day cycle

Primary outcomes

  1. Objective Response Rate (ORR) (Phase II)

    Time frame: Up to approximately 4 years

    ORR was assessed by investigators per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1).

  2. Incidence of Adverse Events (AEs) (Phase II)

    Time frame: Up to approximately 4 years

    An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product.

  3. Overall Survival (OS) (Phase III)

    Time frame: Up to approximately 4 years

    OS was defined as the time from randomization to death due to any cause.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 4 years

    ORR was assessed by investigators per RECIST 1.1

  2. Disease Control Rate (DCR)

    Time frame: Up to approximately 4 years

    DCR was assessed by investigators per RECIST 1.1

  3. Duration of Response (DOR)

    Time frame: Up to approximately 4 years

    DOR was assessed by investigators per RECIST 1.1

  4. Progression-free Survival (PFS)

    Time frame: Up to approximately 4 years

    PFS was assessed by investigators per RECIST 1.1

  5. Time to progression (TTP)

    Time frame: Up to approximately 4 years

    TTP was assessed by investigators per RECIST 1.1

  6. Objective Response Rate (ORR)

    Time frame: Up to approximately 4 years

    ORR was assessed by investigators per mRECIST

  7. Disease Control Rate (DCR)

    Time frame: Up to approximately 4 years

    DCR was assessed by investigators per mRECIST

  8. Duration of Response (DOR)

    Time frame: Up to approximately 4 years

    DOR was assessed by investigators per mRECIST

  9. Progression-free Survival (PFS)

    Time frame: Up to approximately 4 years

    PFS was assessed by investigators per mRECIST

  10. Time to progression (TTP)

    Time frame: Up to approximately 4 years

    TTP was assessed by investigators per mRECIST

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Gao

CONTACT

[email protected]

+8613304321400

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase II/III, Randomized, Open-label, Multi-center Study to Evaluate the Efficacy and Safety of QL1706 in Combination With Bevacizumab and/or Chemotherapy Versus Sintilimab in Combination With Bevacizumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2023
Registry last updated
Aug 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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