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A Study of Combination Therapy in Patients With Resectable Liver Cancer

ConditionLiver Cancer (Primary and Metastatic)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAffiliated Hospital of Guangdong Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Hepatic Arterial Infusion Chemotherapy Combined with Adebrelimab Plus Rivoceranib

    Drug

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

Treatment groups

68 Participants
are divided into 1 treatment group
Group A: Combination Therapy Followed by SurgeryExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
24 months

Secondary outcomes

1

OS

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

Time frame
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

Time frame
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

Time frame
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

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Affiliated Hospital of Guangdong Medical University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: