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

NCT05976568 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: QL1706-308
• Study Type: interventional
• Target: 668
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

• Objective Response Rate (ORR) (Phase II)

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

  Up to approximately 4 years

• Incidence of Adverse Events (AEs) (Phase II)

  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.

  Up to approximately 4 years

• Overall Survival (OS) (Phase III)

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

  Up to approximately 4 years

Secondary Outcomes (10)

• Objective Response Rate (ORR)

  Up to approximately 4 years

• Disease Control Rate (DCR)

  Up to approximately 4 years

• Duration of Response (DOR)

  Up to approximately 4 years

• Progression-free Survival (PFS)

  Up to approximately 4 years

• Time to progression (TTP)

  Up to approximately 4 years

Study Arms (4)

Arm 1

EXPERIMENTAL

QL1706 in combination with bevacizumab and chemotherapy

Drug: QL1706; Drug: Bevacizumab; Drug: Oxaliplatin injection; Drug: Capecitabine

Arm 2

EXPERIMENTAL

QL1706 in combination with bevacizumab

Drug: QL1706; Drug: Bevacizumab

Arm 3

EXPERIMENTAL

QL1706 in combination with chemotherapy

Drug: QL1706; Drug: Oxaliplatin injection; Drug: Capecitabine

Arm 4

ACTIVE COMPARATOR

Sintilimab in combination with bevacizumab

Drug: Bevacizumab; Drug: Sintilimab

Interventions

QL1706 DRUG

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

Arm 1; Arm 2; Arm 3

Bevacizumab DRUG

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

Arm 1; Arm 2; Arm 4

Oxaliplatin injection DRUG

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

Arm 1; Arm 3

Capecitabine DRUG

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

Arm 1; Arm 3

Sintilimab DRUG

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

Arm 4

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, 211199, China

Location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Bevacizumab; Oxaliplatin; Capecitabine; 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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jia Fan

  Fudan University

  PRINCIPAL INVESTIGATOR

• Shukui Qin

  Nanjing Tianyinshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian Gao

CONTACT

+8613304321400; jian7.gao@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: September 1, 2023
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 4, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)