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Liver Cancer (Primary and Metastatic)Phase 2ArcherNCT07684040

A Study of Combination Therapy in Patients With Resectable Liver Cancer

A Phase 2 study testing Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib in people with Liver Cancer (Primary and Metastatic), run by Affiliated Hospital of Guangdong Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of an initial combination treatment strategy followed by surgery in patients with cancer. Eligible participants will receive combination therapy prior to surgical intervention. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Cancer (Primary and Metastatic)
What is being tested?
Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
1 Aug 2026to 1 Oct 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Voluntarily signed written informed consent.
  • 2. Age ≥18 years; male or female.
  • 3. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) according to EASL/AASLD criteria.
  • 4. CNLC stage Ib, IIa, IIb, or IIIa HCC (excluding patients with main portal vein tumor thrombus).
  • 5. Presence of vascular invasion and no extrahepatic metastasis, including PVTT (Vp1-Vp3), HVTT, or IVCTT.
  • 6. No prior systemic treatment for HCC, including chemotherapy, targeted therapy, or immunotherapy.
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  • 7. Child-Pugh class A liver function.
  • 8. ECOG performance status 0-1.
  • 9. Adequate organ function:
  • ANC ≥1.5 × 10^9/L; Platelet count ≥75 × 10^9/L; Hemoglobin ≥90 g/L.
  • Albumin ≥30 g/L; Total bilirubin ≤1.5 × ULN; ALT, AST, and ALP ≤5 × ULN; Serum creatinine ≤1.5 × ULN or creatinine clearance >50 mL/min.
  • INR ≤2.3 or PT prolongation ≤6 seconds.
  • Urine protein <2+; if ≥2+, 24-hour urine protein <1.0 g.
  • 10. For patients with active HBV infection, effective antiviral therapy is required, with HBV DNA ≤2000 IU/mL or a ≥10-fold reduction after antiviral treatment.
  • 11. Women of childbearing potential must have a negative pregnancy test before enrollment and agree to use effective contraception during the study and for 6 months after study completion. Male participants must also use effective contraception during the study and for 6 months after study completion.

Who cannot join

  • 1. Intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, fibrolamellar carcinoma, or any other active malignancy within the past 5 years (except HCC).
  • 2. Severe allergy to iodinated contrast agents that prevents HAIC treatment.
  • 3. Planned or prior organ transplantation or allogeneic bone marrow transplantation.
  • 4. Treatment with another investigational drug within 28 days before study treatment.
  • 5. Current or prior central nervous system metastases.
  • 6. History of hepatic encephalopathy.
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  • 7. Current interstitial pneumonitis or interstitial lung disease.
  • 8. Active autoimmune disease or history of autoimmune disease with risk of recurrence.
  • 9. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before study treatment.
  • 10. Severe infection within 4 weeks before study treatment.
  • 11. Gastrointestinal bleeding within 6 months before study treatment or a known risk of gastrointestinal bleeding.
  • 12. Known hereditary or acquired bleeding disorders or thrombotic tendency.
  • 13. Uncontrolled clinically significant cardiac disease or symptoms.
  • 14. Moderate or severe ascites requiring therapeutic drainage or paracentesis.
  • 15. Major vascular disease within 6 months before study treatment.
  • 16. Inability to swallow oral medication, malabsorption syndrome, or any condition affecting gastrointestinal absorption.
  • 17. Known hypersensitivity to any study drug, its excipients, monoclonal antibodies, or anti-angiogenic agents.
  • 18. Any other serious acute or chronic medical condition, psychiatric disorder, or laboratory abnormality that may increase study risk, interfere with study results, or make the patient unsuitable for participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Dai, M.D, PhD contact

86 + 13828264321

dwgdmufy@gdmu.edu.cn

China1 site

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524000

    Wei Dai, MD, +8613828264321, dwgdmufy@gdmu.edu.cn

Other trials in China

About this study

Official title: A Prospective Single-arm Clinical Study Evaluating the Efficacy and Safety of Hepatic Resection After Initial Hepatic Arterial Infusion Chemotherapy Combined With Adebrelimab Plus Rivoceranib in Patients With Initially Resectable Hepatocellular Carcinoma

This is a prospective, single-arm clinical study designed to evaluate the efficacy and safety of an initial combination treatment strategy followed by surgery in patients with cancer. Eligible participants will receive combination therapy prior to surgical intervention. Patients who meet predefined surgical criteria will undergo hepatic resection. Following surgery, additional treatment may be administered according to the investigator's assessment. The primary objective is to evaluate time to treatment failure (TTF). Secondary objectives include evaluation of pathological response, resection outcomes, progression-related outcomes, survival outcomes, and safety.

Being tested
Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib
Medical subject headings
Liver Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus RivoceranibDrug

    Surgery followed by Hepatic Arterial Infusion Chemotherapy Combined wit Adebrelimab plus Rivoceranib

Study groups in NCT07684040
Study groupRoleWhat they receive
Combination Therapy Followed by SurgeryExperimentalNot described
Receives: Drug: Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Treatment Failure

    Time from initiation of treatment to treatment failure, including disease progression resulting in inability to undergo surgery, recurrence/metastasis after surgery, or death from any cause.

    Measured: 24 months

Secondary outcomes (4)

  1. OS

    Overall survival (OS) after treatment, defined as the time from the start of treatment to death from any cause

    Measured: 24 months

  2. R0 rate

    R0 rate, defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin

    Measured: 24 months

  3. pCR rate

    Pathological complete regression (pCR) rate, defined as the proportion of patients with no evidence of vital residual tumor cells on the complete resected specimen. pCR status will be analyzed by local pathologists at each site

    Measured: 24 months

  4. ORR

    Objective response rate (ORR) , defined as the proportion of patients with a complete response (CR) or partial response (PR), as determined by the investigator according to RECIST v1.1 and HCC mRECIST

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion1 Jul 2030 (estimated)
  4. Study completion1 Oct 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07684040
Sponsor's protocol ID
PJKT2026-198
Acronym
Archer
Status last verified
Jun 2026
First submitted
25 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib in people with Liver Cancer (Primary and Metastatic), run by Affiliated Hospital of Guangdong Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Wei Dai, M.D, PhD (86 + 13828264321, dwgdmufy@gdmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Treatment Failure (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07684040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

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