Nocardia Rubra Cell Wall Skeleton Plus Hepatic Arterial Infusion Chemotherapy, Lenvatinib and Tislelizumab for Advanced Hepatocellular Carcinoma: a Single-center, Single-arm, Non-randomized Clinical Study

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to evaluate the efficacy and safety of Nocardia rubra cell wall skeleton plus hepatic arterial infusion chemotherapy of oxaliplatin, 5-fluorouracil and leucovorin, lenvatinib and tislelizumab in patients with advanced hepatocellular carcinoma (HCC).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Subjects volunteer to participate in the study and agree to sign the informed consent with good compliance and follow-up.

• Subjects are 18 years old or older when signing the informed consent and gender is not limited.

• Subjects were diagnosed with advanced hepatobiliary malignant tumors (clinical stage IV) by imaging and histological examination, including hepatocellular carcinoma, cholangiocarcinoma, ampullary carcinoma, gallbladder carcinoma and mixed carcinoma.

• The disease is not suitable for radical surgery and/or topical treatment, or disease progression occurs after surgery and/or local treatment.

• At least one measurable lesion (according to mRECIST): the measurable lesion has a long diameter ≥ 10 mm or lymphadenpathy has a short diameter ≥ 15 mm in spiral CT scan.

• Patients fail after at least one systemic failure, including surgery, intervention, radiotherapy, chemotherapy and targeted therapy and require palliative treatment.

• Definition of treatment failure: Disease progression during treatment or relapse after treatment, such as after at least once radical or palliative resection surgery, revenue recurrence or progression after intervention therapy or radiotherapy. Intervention therapy or oxaliplatin treatment must be more than 1 cycle, and molecular targeted therapy must more than ≥14 days.

• Definition of intolerance: Grade ≥IV hematologic toxicity, or grade ≥III non- hematologic toxicity, or grade ≥ II damage of heart, liver and kidney during treatment.

• The ECOG score is 0-2 within 1 week before enrollment.

• Liver function assessment: Child-Pugh Grade A or mild Grade B (≤ 7 points), BCLC stage B-C.

• More than 2 weeks from first-line system treatment failure to sign informed consent for this study, and adverse events returned to normal (NCI-CTCAE ≤ I).

• Estimated survival time ≥ 6 months.

• HBV DNA \<2000 IU/ml (104 copies/ml).

• Hematology and organ function are sufficient based on the following laboratory results within 14 days prior to the treatment of this study:

• Whole blood cell examination (no blood transfusion within 14 days, no G-CSF use and no drugs use): Hb≥90g/L, ANC≥1.5×10\*9/L, PLT≥80×10\*9/L.

• Biochemical examination (no ALB infused within 14 days): ALB≥29 g/L, ALT and AST\<5×ULN, TBIL≤1.5×ULN, creatinine≤1.5×ULN (only one of albumin and bilirubin has 2 points with Child-Pugh score).

• Tumor tissue must be available for biomarker analysis prior to the first dose of treatment, If not available, participants can consult the investigator for enrollment agreement.

• Note: If an unstained section is submitted, the new section should be submitted to the laboratory within 14 days.

Locations
Other Locations
China
Hepatic Surgery Center, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITING
Wuhan
Contact Information
Primary
Wan-guang Zhang, M.D.
wgzhang@tjh.tjmu.edu.cn
86-27-83665213
Backup
Ze-yang Ding, M.D.
zyding@tjh.tjmu.edu.cn
86-27-69378710
Time Frame
Start Date: 2022-09-01
Estimated Completion Date: 2025-02-28
Participants
Target number of participants: 30
Treatments
Experimental: Nocardia rubra cell wall skeleton (N-CWS) Plus HAIC, Lenvatinib and Tislelizumab
N-CWS 400μg hypodermic injected every week (Q1W) for 4 weeks, following by N-CWS 400μg hypodermic injected Q4W. Hepatic arterial infusion of oxaliplatin , fluorouracil, and leucovorin every 3 weeks. Lenvatinib 12 mg (or 8 mg) once daily (QD) oral dosing. Tislelizumab 200mg intravenously every 3 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: BeiGene, Geneplus-Beijing Co. Ltd., Yuce Biotechnology Co., Ltd., Simcere Pharmaceutical Co., Ltd, Chinese Cooperative Group of Liver Cancer, Geneis, Haplox Biotechnology Co., Ltd., Chen Xiao-ping Foundation for the Development of Science and Technology of Hubei Province, M&R Pharm
Leads: Wan-Guang Zhang

This content was sourced from clinicaltrials.gov