A Study of Combination Therapy in Patients With Resectable Liver Cancer (Archer)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Liver Cancer (Primary and Metastatic)
• Intervention / Treatment: Drug: Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei Dai, M.D, PhD; Phone Number: 86 + 13828264321; Email: dwgdmufy@gdmu.edu.cn

Study Locations

• China
  • Guangdong
    • Zhanjiang, Guangdong, China, 524000
      • Affiliated Hospital Of Guangdong Medical University
      • Contact: Wei Dai, MD; Phone Number: +8613828264321; Email: dwgdmufy@gdmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.
• 7. Child-Pugh class A liver function.
• 8. ECOG performance status 0-1.

• 9. Adequate organ function:

  1. ANC ≥1.5 × 10^9/L; Platelet count ≥75 × 10^9/L; Hemoglobin ≥90 g/L.
  2. 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.
  3. INR ≤2.3 or PT prolongation ≤6 seconds.
  4. 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Combination Therapy Followed by Surgery	Drug: Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib; Surgery followed by Hepatic Arterial Infusion Chemotherapy Combined wit Adebrelimab plus Rivoceranib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24 months
OS	Overall survival (OS) after treatment, defined as the time from the start of treatment to death from any cause	24 months
R0 rate	R0 rate, defined as the proportion of patients who accomplish the complete resection of tumor with pathologically confirmed negative margin	24 months
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	24 months

Collaborators and Investigators

• Sponsor: Affiliated Hospital of Guangdong Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: June 25, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 6, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathological Conditions, Signs and Symptoms; Neoplasm Metastasis; Liver Neoplasms; apatinib
• Other Study ID Numbers: PJKT2026-198

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No