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Not yet recruitingNCT06958484Updated May 6, 2025

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

A Phase 2 interventional study of Iparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab in HCC - Hepatocellular Carcinoma and Adjuvant Treatment, sponsored by The Affiliated Hospital of Xuzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-06.

Sponsored by The Affiliated Hospital of Xuzhou Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
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Study 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

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Conditions studied

  • HCC - Hepatocellular Carcinoma
  • Adjuvant Treatment
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In context

Carcinoma, Hepatocellular

3,249 studies on the registry are indexed under Carcinoma, Hepatocellular; 974 are open to participants now.

This study's planned enrollment of 60 is close to the median of 55 across 2,347 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

The Affiliated Hospital of Xuzhou Medical University is the lead sponsor of 70 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Voluntarily participate in this study and sign the informed consent form;
  2. Age 18-100 years old, male or female;
  3. Hepatocellular carcinoma confirmed by histopathology, cytology or imaging;
  4. CNLC PHASE I-II;
  5. 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;
  6. 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:

  1. 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;

  2. 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

  3. International normalized ratio (INR) \< = 1.2 or prothrombin time (PT) outside the range of normal controls \< = 2 seconds;
  4. 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.

Exclusion criteria

Exclusion Criteria:

  1. It is known that there are fibrotic plate HCC, sarcomatoid HCC or mixed-type cholangiocarcinoma and HCC;
  2. There is evidence of residual, recurrent or metastatic disease;
  3. History of hepatic encephalopathy;
  4. Previous receipt of allogeneic stem cell or solid organ transplantation, or on the waiting list for liver transplantation;
  5. 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;
  6. 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;
  7. Co-infection with HBV and HCV, co-infection with HBV and delta hepatitis virus infection;
  8. 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;
  9. Active tuberculosis;
  10. 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;
  11. Severe infection within 4 weeks before the first medication, including but not limited to hospitalization due to complications of infection, bacteremia or severe pneumonia;
  12. Received oral or intravenous antibiotic treatment within 2 weeks before the first medication;
  13. Use of non-steroidal anti-inflammatory drugs (NSAIDs) for daily treatment of chronic diseases;
  14. Have bleeding predisposition or significant evidence of coagulation dysfunction (without anticoagulant treatment);
  15. Currently or recently using aspirin or full-dose oral or intravenous anticoagulants;
  16. Hemorrhage events due to untreated or incompletely treated esophageal and/or gastric varices within 6 months before the first medication;
  17. Major vascular diseases (such as aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the first medication;
  18. Inadequate control of arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure >= 90 mmHg) (based on the average value of >= 2 measurements of BP readings), allowing the above parameters to be achieved through the use of antihypertensive treatment; previous occurrence of hypertensive crisis or hypertensive encephalopathy;
  19. Significant uncontrolled or symptomatic hypercalcemia (ionized calcium > 1.5 mmol/L, calcium > 12 mg/dL, or corrected serum calcium > ULN) within 6 months before the first medication;
  20. Within 3 months of having severe cardiovascular diseases (such as NYHA class II or above heart disease, myocardial infarction or cerebrovascular accident), unstable arrhythmias or unstable angina pectoris;
  21. Clinically significant ascites;
  22. Within 6 months before the first medication, having a history of intra-abdominal inflammation, including but not limited to peptic ulcer, diverticulitis or colitis;
  23. Within 6 months before the first medication, having a history of abdominal or tracheoesophageal fistula, gastrointestinal perforation or intra-abdominal abscess;
  24. Severe, non-healing or ruptured wounds, active ulcers or untreated fractures;
  25. Performed hollow needle biopsy or other minor surgeries within 3 days before the first medication, excluding the placement of vascular access devices. 26. Within 4 weeks prior to the first administration of the drug, underwent major surgery, or was expected to undergo major surgery during the study period;

27. Had previously used systemic immunostimulants or immune checkpoint blockade therapy; 28. Was expected to receive systemic immunosuppressive drugs (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-α [TNF-α] preparations) within 2 weeks prior to the first administration of the drug, or was expected to receive systemic immunosuppressive drugs during the study treatment period; 29. Was vaccinated with live vaccines within 30 days prior to the first administration of the drug, or was expected to receive such vaccines during the treatment period or within 5 months after the last administration; 30. Was known to be allergic to any study drug or excipients; 31. Was contraindicated from using the investigational drug, or had any other diseases, metabolic disorders, physical examination findings, or clinical laboratory findings that might affect the interpretation of results or place the patient at a high risk of treatment complications; 32. Had other factors considered by the investigator as unsuitable for participation in the study.

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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Iparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab

    Drug: Iparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab

Interventions

  • DrugIparomlimab and Tuvonralimab Injection (QL1706) plus bevacizumab

    Drug page: Iparomlimab/Tuvonralimab

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

06

What researchers measure

Primary outcomes

  1. One-year recurrence-free survival rate

    Time frame: From enrollment to the end of treatment at 1 year

Secondary outcomes

  1. Relapse-Free Survival at 6 months, RFS6

    Time frame: From enrollment to the end of treatment at 6 months

  2. Relapse-Free Survival, RFS

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

  3. Time To Relapse, TTR

    Time frame: 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

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2025; primary completion for Oct 2026, 17 months later.

Of 328 non-industry phase 2 interventional studies under Carcinoma, Hepatocellular, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 74. This study's planned 17 months is below that.

Counting every sponsor, half of 404 studies reached it within 44 months; a quarter within 31 and three quarters within 70.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 21, 2025
First posted
May 6, 2025
StartEst.
May 1, 2025
Primary completionEst.
Oct 1, 2026
CompletionEst.
Dec 31, 2027
Last update
May 6, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06958484
Lead sponsor
The Affiliated Hospital of Xuzhou Medical University
Responsible party
Sponsor
First posted
May 6, 2025
Start date
May 1, 2025 (estimated)
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
May 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Iparomlimab/Tuvonralimab

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