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Anlotinib + Benmelstobart + HAIC in Unresectable HCC: A Phase II Study

ConditionUnresectable Hepatocellular Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University

About this trial

To evaluate the efficacy and safety of anlotinib combined with benmelstobart and HAIC as first-line treatment for unresectable hepatocellular carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 18 and 75 years, regardless of gender.

Confirmed diagnosis of unresectable hepatocellular carcinoma (HCC) according to both the China Liver Cancer (CNLC) staging criteria and the American Association for the Study of Liver Diseases (AASLD) clinical diagnostic criteria.

At least one measurable lesion as defined by the following criteria: the longest diameter ≥ 10 mm for non-nodal lesions, or the short-axis diameter ≥ 15 mm for nodal lesions; confirmed unresectable HCC; Child-Pugh liver function score ≤ 7.

Naive to any local (ablation, hepatic arterial embolization/infusion therapy, liver transplantation) or systemic therapy (chemotherapy and/or molecular targeted therapy, immunotherapy; antiviral therapy excluded) for HCC at initial diagnosis, or patients with intrahepatic recurrence after previous radical resection.

Disqualifiers

Histologically confirmed fibrolamellar HCC, sarcomatoid HCC, or combined hepatocellular-cholangiocarcinoma (HCC-ICC).

Symptomatic moderate to massive pleural effusion/ascites.

Obstructive jaundice, liver failure, or hepatic encephalopathy.

Patients with a second primary cancer or multiple malignancies, except for HCC, carcinoma in situ of the cervix, and non-melanoma skin cancer, or a history of other malignancies previously diagnosed and explicitly cured for at least 5 years with no evidence of subsequent recurrence.

Trial design

Design model

Single group

Treatments tested in this trial

  • anlotinib combined with benmelstobart and HAIC

    Drug

    HAIC with FOLFOX (oxaliplatin 85 mg/m², leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² bolus followed by 2400 mg/m² over 23 h) plus oral anlotinib 10 mg (d1-14) and intravenous benmelstobart 1200 mg (d1) every 3 weeks

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Experimental: anlotinib combined with benmelstobart and HAICExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

objective response rate (ORR)

ORR as assessed by the investigator using RECIST v1.1 criteria

Time frame
12 months

Secondary outcomes

1

ORR (mRECIST)

ORR as assessed by the investigator using mRECIST

Time frame
12 months
2

progression free survival (PFS)

PFS was defined as the time from the start of treatment to the date of first documentation of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or date of death, whichever occurred first.

Time frame
up to 24 months
3

overall survival (OS)

OS is the time interval from the start of treatment to death due to any reason or loss of follow-up

Time frame
up to 24 months
4

Surgical conversion rate

The proportion of patients with initially unresectable hepatocellular carcinoma who become eligible for surgical resection after treatment, relative to all enrolled and treated patients.

Time frame
up to 12 months

Other outcomes

Sponsors and contacts

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

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Lead sponsor

Source ClinicalTrials.gov
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