Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC

ConditionHepatocellular Carcinoma

Trial statusRecruiting

Trial phasePhase 2, Phase 3

Trial typeInterventional

Biological sexAll

Age18-75

SponsorGuangxi Medical University

About this trial

This study intends to prospectively enroll CNLC stage IIIb HCC cases with extrahepatic metastasis and intrahepatic lesions that are expected to be radical resected in several domestic clinical centers, and observe the OS and ORR, DCR, DOR, TTP and PFS of patients receiving hepatectomy combined with apatinib + carrelli pearl treatment.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18

CNLC stage IIIb HCC with extrahepatic metastasis (such as lymph node, lung, bone metastasis, but not brain metastasis) diagnosed by clinical imaging, and at least one measurable metastasis can be used as RECIST V1.1 to observe the objective efficacy of "targeted + immune" therapy on target lesions;

Local tumors of the liver are expected to be radically resected;

Liver function Child-Pugh grade A;

Disqualifiers

Have a history or concurrence of other malignancies, except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;

Have used or are currently using other immunosuppressive or chemotherapy drugs for HCC (including but not limited to atezolizumab, nivolumab, pembrolizumab, tislelizumab, toripalimab, sintilimab, camrelizumab, S-1, etc.);

Patients who have received TACE, radiotherapy or systemic therapy within the past 6 months;

The presence of congenital or acquired immune deficiency diseases (such as HIV positive);

Trial design

Design model

Single group

Treatments tested in this trial

Hepatectomy Combined With Camrelizumab and Apatinib
Drug
Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments.

Treatment groups

62 Participants

are divided into 1 treatment group

Group A: Hepatectomy Combined With Camrelizumab and ApatinibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Overall survival

OS is defined as the time from the hepatectomy to death from any cause.

Time frame

2 years

Secondary outcomes

Objective response rate of extrahepatic target lesions

Objective response rate is defined as the proportion of patients with complete response or partial response.

Time frame

6 months

Sponsors and contacts

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

Guangxi Medical University

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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