Iparomlimab and Tuvonralimab Injection (QL1706) Combined With Bevacizumab for Postoperative Adjuvant Therapy in Hepatocellular Carcinoma (HCC) With High Risk of Recurrence

NCT06958484 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: XYFY2025-KL117-01
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluation of the efficacy and safety of Iparomlimab and Tuvonralimab Injection (QL1706) in combination with bevacizumab for postoperative adjuvant treatment of HCC with high-risk recurrence risk

Conditions

HCC - Hepatocellular Carcinoma; Adjuvant Treatment

Outcome Measures

Primary Outcomes (1)

• One-year recurrence-free survival rate

  From enrollment to the end of treatment at 1 year

Secondary Outcomes (3)

• Relapse-Free Survival at 6 months, RFS6

  From enrollment to the end of treatment at 6 months

• Relapse-Free Survival, RFS

  From enrollment to through study completion, an average of 1 year

• Time To Relapse, TTR

  From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first,assessed up to 24 months

Study Arms (1)

Iparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab

EXPERIMENTAL

Drug: Iparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab

Interventions

Iparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab DRUG

The patients with high-risk recurrence will be treated with Iparomlimab and Tuvonralimab Injection (QL1706) in combination with bevacizumab for postoperative adjuvant treatment .

Iparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate in this study and sign the informed consent form;
• Age 18-100 years old, male or female;
• Hepatocellular carcinoma confirmed by histopathology, cytology or imaging;
• CNLC PHASE I-II;
• After surgical resection or local ablation, the intraoperative pathology shows that there is no residual resection margin, or R0 is confirmed by imaging within 4\~8 weeks after surgery;
• Have at least one high-risk recurrence factor:
• (Definition of high-risk recurrence factors: Definition of high-risk recurrence factors: after radical surgery: presence of a single tumor \>5 cm in diameter; Number of tumors\>=3; concomitant vascular invasion (microvascular invasion or Vp1-2); Tumor grade III-IV; Post-ablation: 1. Single tumor \>2cm but \<= 5cm; 2. Multiple tumors: 2-4, all tumors \<= 5 cm); 7. ECOG PS score: 0\~1 points; 8. Child-Pugh Liver Function Rating: Grade A (\< = 6 points) 9. Expected survival time \>=12 months; 10. The laboratory test values within 3 days before the first dose meet the following requirements:
• Routine blood test: (except for hemoglobin, no blood transfusion, no use of granulocyte colony-stimulating factor \[G-CSF\], no correction with medication within 2 weeks prior to screening):
• Absolute neutrophil count \>=1.5×10\^9/L; Platelets \>=75×10\^9/L; Hemoglobin \>=90 g/L;
• Biochemical examination:
• serum albumin \>=30g/L; Serum total bilirubin \< = 1.5×ULN; ALT and AST \<= 3×ULN; Serum creatinine \< = 1.5×ULN; or Cr clearance \>50 mL/min
• International normalized ratio (INR) \< = 1.2 or prothrombin time (PT) outside the range of normal controls \< = 2 seconds;
• urine protein \<2 (if urine protein \>=2, 24-hour (h) urine protein quantification can be performed, and 24-hour urine protein quantification \<1.0g can be enrolled); 11. If you have hepatitis B virus (HBV) infection, if HBsAg is positive, you need to test for HBV-DNA, and the HBV-DNA needs to be \<2000 IU/mL (if the site only has a copy/mL testing unit, it must be \< 104 copy/mL); For subjects with HBV-DNA\>=2000 IU/mL, at least 1 week of antiviral therapy (only nucleosides such as entecavir, tenofovir disoproxil fumarate, and tenofovir alafenol tablets are allowed) prior to the first dose, and the viral copy number decreased by more than 10-fold (1 lg) compared to before the first dose. For patients with HBV infection, antiviral therapy is required throughout the study. Hepatitis C virus (HCV)-RNA positive subjects must be on antiviral therapy as per treatment guidelines; 12. Women of childbearing potential must have a negative pregnancy test (βHCG) before starting the first dose. Women of childbearing potential and men (sexually active with women of childbearing potential) must agree to contraception during treatment and within 6 months of the last dose.

You may not qualify if:

• It is known that there are fibrotic plate HCC, sarcomatoid HCC or mixed-type cholangiocarcinoma and HCC;
• There is evidence of residual, recurrent or metastatic disease;
• History of hepatic encephalopathy;
• Previous receipt of allogeneic stem cell or solid organ transplantation, or on the waiting list for liver transplantation;
• Any treatment before HCC resection or ablation, including systemic treatment (including experimental drugs) and local treatment, such as TACE; and subjects who received more than one cycle of adjuvant TACE treatment after surgical resection;
• Within 5 years before the first medication, there is a history of malignant tumors other than HCC, with negligible risk of metastasis or death (such as 5-year OS rate \> 90%), such as fully treated cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer;
• Co-infection with HBV and HCV, co-infection with HBV and delta hepatitis virus infection;
• History of idiopathic pulmonary fibrosis, organizing pneumonia (such as obliterative bronchiolitis), drug-induced pneumonia or idiopathic pneumonia, or chest CT scan at screening shows evidence of active pneumonia;
• Active tuberculosis;
• History of autoimmune diseases or immunodeficiency diseases, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome or multiple sclerosis;
• Severe infection within 4 weeks before the first medication, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia;
• Received oral or intravenous antibiotic treatment within 2 weeks before the first medication;
• Use of non-steroidal anti-inflammatory drugs (NSAIDs) for daily treatment of chronic diseases;
• Have bleeding predisposition or significant evidence of coagulation dysfunction (without anticoagulant treatment);
• Currently or recently using aspirin or full-dose oral or intravenous anticoagulants;

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2025
• First Posted: May 6, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share