A Study of Combination Therapy in Patients With Resectable Liver Cancer

NCT07684040 | Not Yet Recruiting Phase 2

• 1 other identifier: PJKT2026-198
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Liver Cancer (Primary and Metastatic)

Outcome Measures

Primary Outcomes (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.

  24 months

Secondary Outcomes (4)

• OS

  24 months

• R0 rate

  24 months

• pCR rate

  24 months

• ORR

  24 months

Study Arms (1)

Combination Therapy Followed by Surgery

EXPERIMENTAL

Drug: Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib

Interventions

Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib DRUG

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

Combination Therapy Followed by Surgery

Eligibility Criteria

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

You may qualify if:

• \. Voluntarily signed written informed consent.
• \. Age ≥18 years; male or female.
• \. Histologically, cytologically, or clinically confirmed hepatocellular carcinoma (HCC) according to EASL/AASLD criteria.
• \. CNLC stage Ib, IIa, IIb, or IIIa HCC (excluding patients with main portal vein tumor thrombus).
• \. Presence of vascular invasion and no extrahepatic metastasis, including PVTT (Vp1-Vp3), HVTT, or IVCTT.
• \. No prior systemic treatment for HCC, including chemotherapy, targeted therapy, or immunotherapy.
• \. Child-Pugh class A liver function.
• \. ECOG performance status 0-1.
• \. 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.
• \. 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.
• \. 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.

You may not qualify if:

• \. Intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed hepatocellular carcinoma, fibrolamellar carcinoma, or any other active malignancy within the past 5 years (except HCC).
• \. Severe allergy to iodinated contrast agents that prevents HAIC treatment.
• \. Planned or prior organ transplantation or allogeneic bone marrow transplantation.
• \. Treatment with another investigational drug within 28 days before study treatment.
• \. Current or prior central nervous system metastases.
• \. History of hepatic encephalopathy.
• \. Current interstitial pneumonitis or interstitial lung disease.
• \. Active autoimmune disease or history of autoimmune disease with risk of recurrence.
• \. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 14 days before study treatment.
• \. Severe infection within 4 weeks before study treatment.
• \. Gastrointestinal bleeding within 6 months before study treatment or a known risk of gastrointestinal bleeding.
• \. Known hereditary or acquired bleeding disorders or thrombotic tendency.
• \. Uncontrolled clinically significant cardiac disease or symptoms.
• \. Moderate or severe ascites requiring therapeutic drainage or paracentesis.
• \. Major vascular disease within 6 months before study treatment.

Sponsors & Collaborators

• Affiliated Hospital of Guangdong Medical University: lead

Study Sites (1)

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524000, China

Location

MeSH Terms

Conditions

Liver Neoplasms; Neoplasm Metastasis

Interventions

apatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wei Dai, M.D, PhD

CONTACT

86 + 13828264321; dwgdmufy@gdmu.edu.cn

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: June 25, 2026
• First Posted: July 6, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): October 1, 2030
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)