Hepatectomy Combined With Camrelizumab and Apatinib in CNLC Stage IIIb HCC

NCT05062837 | Unknown Phase 2 DMC

• 1 other identifier: HCCA-HCC
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

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

  2 years

Secondary Outcomes (1)

• Objective response rate of extrahepatic target lesions

  6 months

Study Arms (1)

Hepatectomy Combined With Camrelizumab and Apatinib

EXPERIMENTAL

Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments.

Drug: Hepatectomy Combined With Camrelizumab and Apatinib

Interventions

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.

Hepatectomy Combined With Camrelizumab and Apatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);
• Known severe allergic reactions to PD-1 mab;
• Within 7 days of enrollment, body temperature of unknown etiology ≥ 38.5℃ or white blood cell count \> 15 x 109/L;
• Patients with hemorrhagic diseases (including but not limited to moderate/severe esophagogastric varices, gastrointestinal bleeding, hemorrhagic gastric ulcer, hemoptysis \> 2.5 ml per day) within 3 months of enrollment;For cases with positive occult blood in stool, occult blood should be reexamined, and gastroenteroscopy should be performed if necessary);
• Arterial or venous thrombosis, such as cerebrovascular accident (transient ischemic attack, cerebral hemorrhage, cerebral infarction, etc.), deep venous thrombosis and pulmonary infarction, etc., 6 months before enrollment;
• Those who have a history of alcohol or psychotropic drug abuse and cannot get rid of it or have mental disorders;
• Breast-feeding women;
• Autoimmune diseases in active stage or previous autoimmune diseases (such as autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism, etc.);
• Were using immunosuppressant or hormone therapy 2 weeks before enrollment;
• Grade 1 CTCAE was not recovered after less than 5 drug half-lives with the last use of molecular targeted therapy or due to adverse events caused by previous therapy;
• Complicated with hepatic encephalopathy or brain metastasis;
• Hypertension beyond drug control (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);

Sponsors & Collaborators

• Guangxi Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Guangxi Medical University Cancer Hospital

Nanning, 530021, China

RECRUITING

Related Publications (4)

• Xu J, Shen J, Gu S, Zhang Y, Wu L, Wu J, Shao G, Zhang Y, Xu L, Yin T, Liu J, Ren Z, Xiong J, Mao X, Zhang L, Yang J, Li L, Chen X, Wang Z, Gu K, Chen X, Pan Z, Ma K, Zhou X, Yu Z, Li E, Yin G, Zhang X, Wang S, Wang Q. Camrelizumab in Combination with Apatinib in Patients with Advanced Hepatocellular Carcinoma (RESCUE): A Nonrandomized, Open-label, Phase II Trial. Clin Cancer Res. 2021 Feb 15;27(4):1003-1011. doi: 10.1158/1078-0432.CCR-20-2571. Epub 2020 Oct 21.

  PMID: 33087333 BACKGROUND

• Finn RS, Ikeda M, Zhu AX, Sung MW, Baron AD, Kudo M, Okusaka T, Kobayashi M, Kumada H, Kaneko S, Pracht M, Mamontov K, Meyer T, Kubota T, Dutcus CE, Saito K, Siegel AB, Dubrovsky L, Mody K, Llovet JM. Phase Ib Study of Lenvatinib Plus Pembrolizumab in Patients With Unresectable Hepatocellular Carcinoma. J Clin Oncol. 2020 Sep 10;38(26):2960-2970. doi: 10.1200/JCO.20.00808. Epub 2020 Jul 27.

  PMID: 32716739 BACKGROUND

• Finn RS, Qin S, Ikeda M, Galle PR, Ducreux M, Kim TY, Kudo M, Breder V, Merle P, Kaseb AO, Li D, Verret W, Xu DZ, Hernandez S, Liu J, Huang C, Mulla S, Wang Y, Lim HY, Zhu AX, Cheng AL; IMbrave150 Investigators. Atezolizumab plus Bevacizumab in Unresectable Hepatocellular Carcinoma. N Engl J Med. 2020 May 14;382(20):1894-1905. doi: 10.1056/NEJMoa1915745.

  PMID: 32402160 BACKGROUND

• Huang JT, Zhong JH, Zhang J, Gong WF, Ma L, Li LQ, Xiang BD. Hepatectomy combined with apatinib and camrelizumab for CNLC stage IIIb hepatocellular carcinoma: a phase II trial protocol. BMJ Open. 2023 Sep 28;13(9):e067730. doi: 10.1136/bmjopen-2022-067730.

  PMID: 37770273 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

camrelizumab; apatinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Bang-De Xiang, Ph.D

  Guangxi Medical University Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bang-De Xiang, Ph.D

CONTACT

+86 771 5301253; xiangbangde@gxmu.edu.cn

Jian-Hong Zhong, Ph.D

CONTACT

15296561499; zhongjianhong@gxmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Tumor response will be assessed with revised Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and mRECIST. All imaging data were independently assessed by one radiologist who is blinded to the clinical data and one hepatologist who is not blinded to the clinical data.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangxi Medical University Cancer Hospital

Model Details: Hepatectomy Combined With Camrelizumab and Apatinib

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: September 30, 2021
• Study Start: June 1, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 23, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)