Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb Hepatocellular Carcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: t
View:

• 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;

• ICG R15 \< 10%;

• ECOG PS 0 or 1 score;

• Estimated survival time ≥6 months;

• Hematological indexes should meet the following conditions: hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5×109/L; Platelet ≥80×109/L; Total bilirubin ≤1.5×ULN; ALT 3 x ULN or less;AST 3 x ULN or less; Alkaline phosphatase (AKP) ≤2.5×ULN; Serum albumin ≥28 g/L; Serum creatinine ≤1.5×ULN;

• The patient is unwilling to receive TACE or radiotherapy;

• For women of childbearing age, contraceptive measures (such as intrauterine devices, contraceptive tablets or condoms) should be used during the clinical trial until 3 months after the clinical trial ends; Serum or urine HCG test was negative for women of childbearing age within 72 hours prior to study enrollment. Effective contraception should be used during the study period and for three months after the end of the study for male patients with fertile partners.

Locations
Other Locations
China
Guangxi Medical University Cancer Hospital
RECRUITING
Nanning
Contact Information
Primary
Bang-De Xiang, Ph.D
xiangbangde@gxmu.edu.cn
+86 771 5301253
Backup
Jian-Hong Zhong, Ph.D
zhongjianhong@gxmu.edu.cn
15296561499
Time Frame
Start Date: 2021-06-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 62
Treatments
Experimental: Hepatectomy Combined With Camrelizumab and Apatinib
Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments.
Related Therapeutic Areas
Sponsors
Leads: Guangxi Medical University
Collaborators: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov