TQB2450 Combined With Anlotinib Hydrochloride in the Perioperative Treatment of Hepatocellular Carcinoma Hydrochloride Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With a High Risk of Recurrence or Metastasis

Chinese Academy of Medical Sciences20 enrolled

Overview

In this study, single cell transcriptome sequencing will be performed on the tissue samples punctured and the surgically resected specimens to explore the gene mutation sites related to efficacy

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Patients With Resectable Hepatocellular Carcinoma Who Are at High Risk of Recurrence or Metastasi

Interventions

Anlotinib hydrochloride capsules＋ TQB2450 injectionDRUG

Anlotinib hydrochloride capsules is a new type of small molecule multi-target tyrosine kinase inhibitor against angiogenesis. TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Voluntary participation and written informed consent; 2. Age: 18-75 years old;ECOG PS：0-1；The expected survival is more than 6 months; 3. No gender limitation; 4. Histologically confirmed hepatocellular carcinoma; 5. Meet resectable surgical criteria; 6. Child-Pugh:A or B; 7. According to RECIST 1.1, there is at least one evaluable lesion that has not been treated; Exclusion Criteria: 1. Fibrolamellar HCC, sarcomatoid HCC, or mixed bile duct cell-HCC is known to exis; 2. Preoperative systemic treatment including chemotherapy, targeted therapy and immunotherapy;Preoperative local treatment including radiotherapy, interventional therapy and ablative therapy; 3. No radical resection could be performed after adequate imaging evaluation; 4. Present or present with other malignant tumors within 3 years.Two conditions were eligible for inclusion: 5 consecutive years of disease-free survival (DFS) for other malignancies treated with a single operation;Cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)\]; 5 . There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 6\. Hepatitis B combined with hepatitis C; 7. Patients with portal hypertension have high bleeding risk considered by the researcher, or gastroscopy or gastroscopy confirmed red signs, or gastroscopy found active ulcers with high bleeding risk;

Locations (1)

Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Pathological complete response rate (pCR)

No histologic evidence of malignancy or only the ingredients of carcinoma in situ was found in primary tumors.

Time frame: 6 months

Overall response rate (ORR)

Objective response rate refers to the percentage of complete (CR) or partial response (PR) subjects determined by the investigator based on RECIST 1.1 .

Time frame: through study completion, an average of 6 months

Secondary Outcomes

Progression free survival(PFS)

Disease control rate refers to the percentage of subjects with a disease stabilization (SD) of 6 weeks or greater in complete response, partial response, or at least 6 weeks, as determined by RECIST 1.1.

Time frame: through study completion, an average of 1 year

Overall survival (OS)

It is defined as the time from randomization to death from any cause during the course of the study

Time frame: through study completion, an average of 1 year

The incidence and severity of AE

AE is any adverse medical event that occurs in a subject participating in a clinical trial that may or may not have a causal relationship with the treatment.An AE can be any adverse and unexpected signs (including abnormal laboratory results), symptoms, or diseases that are time-related to the use of the study drug, whether or not the study drug is considered relevant.

Time frame: through study completion, an average of 1 year

The incidence and severity of SAE

When subjects were tested with drug adverse events of comply with the following one or more than a standard as a serious adverse event (SAE) : death, life-threatening, permanent or severe disability or loss of function, subjects requiring hospitalization or extend the length of hospital stay, congenital anomaly, or birth defects, subsequent pregnancy happen (natural or artificial abortion, the pregnancy is terminated because of medical reasons) and other important medical event (no threat to life or death, but may endanger patients or may lead to interventions are needed to prevent this happen).

Data from ClinicalTrials.gov

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